MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-60-030-120-P6
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of stenosis is listed in the supera instructions for use, as a known patient effect of peripheral stenting procedures.Based on the information reviewed, there is no indication of a product quality issue.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The additional non-surgical treatment was related to operational context.The additional 2 supera stents referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported that on (b)(6) 2016 three supera stents were deployed in the superficial femoral artery.Due to restenosis observed in the previously treated area, the patient underwent revascularization on (b)(6) 2016.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 5914943
• Report Number: 2024168-2016-05815
• Device Sequence Number: 25958
• Product Code: NIP
• UDI-Device Identifier: 08717648211881
• UDI-Public: (01)08717648211881(17)170731(10)5082161
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: S-60-030-120-P6
• Device Lot Number: 5082161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2016
• Initial Report FDA Received Date: 08/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: SUPERA (X2)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 56