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

Catalog Number	S-65-150-120-P6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis (2100); Stenosis (2263); Claudication (2550)
Date of Event	02/11/2019
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.The device was not returned for evaluation.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 thrombosis, claudication and restenosis are listed in the supera instructions for use as known potential patient effects.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 were due to circumstances of the procedure as a non-abbott stent was deployed and sufficiently restored the blood flow.Based on the information reviewed, there is no indication of a product quality issue.The 6.0x100mm supera stent referenced is being filed under a separate medwatch mfr number.
Event or Problem Description
It was reported that a procedure was performed on (b)(6) 2018 to treat a severely calcified right popliteal and superficial femoral artery.A 6.0x100mm supera stent was implanted in the right proximal popliteal, and a 6.5x150mm supera stent was implanted in the right superficial femoral artery (sfa), overlapping the 6.0x100mm supera stent.There were no reported issues during the procedure.The patient was compliant with plavix and aspirin medications following the procedure; however, the dosage is unknown.On (b)(6) 2019, the patient presented with leg claudication and a severely calcified right popliteal and sfa.Angiography discovered restenosis in the previously implanted supera stents and thrombus distal to the stents that shut down both stent segments and resulted in no flow.A non-abbott stent was deployed and sufficiently restored the blood flow.There was no adverse patient sequela, and there was no reported clinically significant delay in the procedure.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: 8376029
• Report Number: 2024168-2019-01536
• Device Sequence Number: 1697500
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: 08717648226328
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: 04/30/2019
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 7051761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/27/2019
• 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: 76 YR
• Patient Weight: 78