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

Catalog Number	S-55-100-120-P6
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	09/12/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A partial udi is being reported because the lot number was not provided.The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the stent remains in the anatomy.A review of the job traveler for this product could not be performed and the historical data for the reported lot could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effect of stenosis is listed in the supera instructions for use 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 and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2016, a supera stent was successfully implanted in the superficial femoral artery.On (b)(6) 2016, the patient presented with leg pain.On (b)(6) 2016, a diagnostic angiogram was performed revealing 90% proximal and 50% mid stent restenosis.The patient had angioplasty treatment with a good outcome.There was no reported adverse patient sequela.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: 5968024
• Report Number: 2024168-2016-06258
• Device Sequence Number: 570470
• Product Code: NIP
• UDI-Device Identifier: 08975370026313
• UDI-Public: (01)08975370026313
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/21/2016

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 Catalogue Number: S-55-100-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2016
• Initial Report FDA Received Date: 09/21/2016
• 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: 59 YR
• Patient Weight: 68