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

Catalog Number	S-55-040-120-P6
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Date of Event	07/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.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 pain and stenosis are listed in the supera instructions for use as known patient effects 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 effects, and the relationship to the product, if any, cannot be determined.The additional non-surgical treatment and hospitalization was related to operational context.
Event or Problem Description
It was reported that on (b)(6) 2015, one supera stent was implanted in the superficial femoral artery.The patient had calf pain and in-stent restenosis on (b)(6) 2016.Laser atherectomy and balloon angioplasty were performed.The condition resolved.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: 5880541
• Report Number: 2024168-2016-05458
• Device Sequence Number: 16297495
• Product Code: NIP
• UDI-Device Identifier: 08975370026283
• UDI-Public: (01)08975370026283(17)160630(10)02368057
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2016

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: 06/30/2016
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 02368057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/16/2016
• 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
• Patient Age: 66 YR