MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA PERIPHERAL STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number S-65-080-080-P6

Device Problem Material Deformation (2976)

Patient Problems Thrombosis (2100); Claudication (2550)

Event Date 03/03/2020

Event Type  Injury  

Manufacturer Narrative

The reported patient effect of thrombosis is listed in the supera instruction for use as a potential adverse effect of peripheral percutaneous intervention.The device was not returned for evaluation.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of thrombosis is listed in the supera instruction for use as a potential adverse effect of peripheral percutaneous intervention.Based on the information provided, a conclusive cause for the reported stent material deformation and subsequent patient effects could not be determined.It may be possible that the supera stent was subjected to stress/fatigue or repetitive movement due to anatomical conditions and location of the implant; however, this could not be confirmed.The additional therapy/non-surgical treatment, surgical procedure, treatment with medications and hospitalization were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the supera self expanding stent (ses) appeared twisted 7 months after it was implanted in a veign graft bypass popliteal segment.The patient was re-hospitalized and treated with overnight thrombolysis for the blocked graft.There was a thrombus about 10 cm above the stent and was confirmed with angiography.Thrombus was discovered because the patient was experiencing rest pain.It was attempted to untwist the stent with balloon angioplasty as well as placing an additional stent.The patient has been referred to vascular surgery to consider options.The physician remarked that they were pleased with the performance of the ses.No additional information was provided.

Manufacturer Narrative

An abbott vascular medical affairs expert reviewed the details of the case and the angiographic images provided.The results of the review are as follows: the supera self expanding stent has an obvious twist.It is unclear as to whether this happened during deployment or between the placement and return visit to the hospital.The cause is unknown.Based on the information provided and review of the provided angiographic images, a conclusive cause for the reported stent material deformation and subsequent patient effects could not be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9883901
• MDR Text Key: 188405124
• Report Number: 2024168-2020-02939
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-65-080-080-P6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR