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Case Study: A Promising Device Fails in the Market Due to Usability Issues
In March, 2025, FDA announced the Class I recall of the Tack Endovascular System (TES), indicated for treating dissection of the blood vessels after they are widened using a balloon or stent (angioplasty):
Philips is recalling Tack Endovascular Systems due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant. All customers should stop using the Tack Endovascular System immediately. Philips will no longer distribute this system for use.
In an Urgent Field Safety Notice sent to customers, Philips disclosed potential harms to patients:
The following harms were observed or could reasonably be expected: failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
TES was an innovative solution to a tough medical problem - treating dissections below the knee, where complex anatomical variations present unique challenges not easily resolved using conventional stents.
So, what went wrong? Innovative technology, FDA-approved device, excellent safety and effectiveness results in multiple clinical trials. Apparently these were not sufficient for market success.
🎧Listen to this brief audio summary of this case and lessons QA/RA and Clinical professionals can apply in practice.
Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.
Note:
The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. A total of 16 sources were used to generate this summary. Here are a few key resources:
* P180034, Intact Vascular, Inc., Approved April 2019.
* P190027, Intact Vascular, Inc., Approved April 2020.
* Philips Press Releases, Issued April 27, 2020, June 03, 2021, June 13, 2022.
* Philips Urgent Fields Safety Notice, January 2025.
* Anatomy, Bone Pelvis and Lower Limb: Popliteal Artery, https://www.ncbi.nlm.nih.gov/books/NBK537125/.
* Popliteal Artery and Its Branches; AJR 150:435-437, February 1988, 0361 -803X/88/1 502-0435 © American Roentgen Ray Society.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe
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By Casual and informal conversations about practical aspects of medical device risk management.
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In March, 2025, FDA announced the Class I recall of the Tack Endovascular System (TES), indicated for treating dissection of the blood vessels after they are widened using a balloon or stent (angioplasty):
Philips is recalling Tack Endovascular Systems due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant. All customers should stop using the Tack Endovascular System immediately. Philips will no longer distribute this system for use.
In an Urgent Field Safety Notice sent to customers, Philips disclosed potential harms to patients:
The following harms were observed or could reasonably be expected: failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
TES was an innovative solution to a tough medical problem - treating dissections below the knee, where complex anatomical variations present unique challenges not easily resolved using conventional stents.
So, what went wrong? Innovative technology, FDA-approved device, excellent safety and effectiveness results in multiple clinical trials. Apparently these were not sufficient for market success.
🎧Listen to this brief audio summary of this case and lessons QA/RA and Clinical professionals can apply in practice.
Thanks for reading Let's Talk Risk!. This post is public so feel free to share it.
Note:
The audio summary was prepared using Google NotebookLM, an AI-enabled research tool. A total of 16 sources were used to generate this summary. Here are a few key resources:
* P180034, Intact Vascular, Inc., Approved April 2019.
* P190027, Intact Vascular, Inc., Approved April 2020.
* Philips Press Releases, Issued April 27, 2020, June 03, 2021, June 13, 2022.
* Philips Urgent Fields Safety Notice, January 2025.
* Anatomy, Bone Pelvis and Lower Limb: Popliteal Artery, https://www.ncbi.nlm.nih.gov/books/NBK537125/.
* Popliteal Artery and Its Branches; AJR 150:435-437, February 1988, 0361 -803X/88/1 502-0435 © American Roentgen Ray Society.
This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe
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