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 Code	Stenosis (2263)
Date of Event	08/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 4.5x60mm supera referenced is being filed under a separate medwatch mfr number.The device was not returned for evaluation.The reported patient effects of restenosis and surgery are listed in the supera instructions for use as known patient effects.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 effects, and the relationship to the product, if any, cannot be determined.The additional treatment (surgery) and hospitalization are related to operational context.
Event or Problem Description
It was reported that the index procedure was on (b)(6) 2016 where two supera stents (4.5 x 60 mm and 4.5 x 100 mm) were implanted in the left superficial femoral artery.On (b)(6) 2016, the patient was returned with in-stent restenosis and the patient was taken for bypass surgery.The patient is doing good.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: 5902332
• Report Number: 2024168-2016-05676
• Device Sequence Number: 13454028
• Product Code: NIP
• UDI-Device Identifier: 08975370026269
• UDI-Public: (01)08975370026269(17)161231(10)02411054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/24/2016

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: 12/31/2016
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 02411054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2016
• Initial Report FDA Received Date: 08/24/2016
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 83 YR