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

Catalog Number 42055040-120

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot history record (lhr) 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 investigation was unable to determine a definitive cause for the reported difficulties.It may be possible that forward/pushing movement of the supera delivery system during stent deployment caused the stent to shorten; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The other devices (supera and two emboshield) are filed under separate medwatch report numbers.

Event Description

It was reported that on (b)(6) 2011 a supera stent was successfully implanted in the popliteal artery.On (b)(6) 2020, the patient was hospitalized due to symptoms of peripheral arterial disease and the stent was noted to be re-stenosed.An emboshield nav6 was placed for distal protection; however, it was noticed that the nav6 became stuck with the atherectomy device, so both systems were removed together as a single unit.A new nav6 was placed and new atherectomy systems were used.During use, and after the filter was fully deployed, the nav6 moved proximal on the barewire, but the nav6 was kept in the anatomy and a supera stent was implanted.After stent implantation, the nav 6 was removed.Additional stenosis was noted distal to the implanted stent, so lesion pre-dilatation was performed and a 5.5x40 supera stent was advanced and implanted; however, the stent shortened during deployment.Next a 5.5x60 supera stent was implanted between the two implanted stents to fully treat the lesion and the procedure was completed.There was no reported adverse patient sequela or a clinically significant delay in procedure.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10653300
• MDR Text Key: 213922558
• Report Number: 2024168-2020-08424
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42055040-120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1