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 Code	Occlusion (1984)
Date of Event	07/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.The reported patient effect of occlusion is listed in the supera instructions for use as a known potential patient effect associated with the use of the device.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 therapy / nonsurgical treatment is due to case circumstances.
Event or Problem Description
It was reported that the procedure was to treat a left superficial femoral artery.A 5.5 x 40 mm supera stent was implanted on (b)(6) 2015.On (b)(6) 2016 the patient returned with the stent occluded.The occlusion was treated with atherectomy, laser and a balloon catheter.The patient is doing well.There was no clinically significant delay in the procedure.No additional information was received.

• 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: 5855110
• Report Number: 2024168-2016-05239
• Device Sequence Number: 1227477
• 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): 08/08/2016

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: 07/25/2016
• Initial Report FDA Received Date: 08/08/2016
• 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: Required Intervention
• Patient Age: 70 YR