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

Catalog Number	S-45-100-120-P6
Health Effect - Clinical Codes	Stenosis (2263); Diminished Pulse Pressure (2606)
Date of Event	05/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 effect of stenosis is listed in the supera instructions for use (ifu) as a known patient effect of peripheral stenting procedures.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.There is no indication of a product quality issue.
Event or Problem Description
It was reported that on (b)(6) 2016, following predilatation, a supera stent was implanted in the proximal popliteal, heavily calcified lesion without issue.On (b)(6) 2017, during a follow-up visit, the patient presented with poor circulation.Imaging was performed and stenosis was noted in the supera stent.No treatment has yet been reported and there was no hospitalization.Percutaneous transluminal intervention is a possible treatment in the future.There was no additional information provided regarding this issue.

• 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: 6603141
• Report Number: 2024168-2017-04645
• Device Sequence Number: 18984032
• Product Code: NIP
• UDI-Device Identifier: 08975370026269
• UDI-Public: (01)08975370026269(17)180831(10)6091561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/31/2017

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: 08/31/2018
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 6091561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other