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

Catalog Number	S-55-150-120-P6
Health Effect - Clinical Codes	Pain (1994); Stenosis (2263)
Date of Event	02/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.The lot history record could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of pain and stenosis are listed in the supera instructions for use as known patient effects.Based on the case information, a conclusive cause for the reported patient effects 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) 2017, two supera stents were implanted in the superficial femoral artery (sfa).Several weeks later, the patient had leg pain at rest.Ct scan of the patient found restenosis in the 5.5 diameter supera stent.The 6.0 diameter supera stent was fully patent.The patient will be scheduled for a femoral-popliteal bypass surgery.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: 6347885
• Report Number: 2024168-2017-01420
• Device Sequence Number: 13585297
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: (01)08975370026337
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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 Catalogue Number: S-55-150-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIFESTENT, 6.0 MM SUPERA STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 100