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

Catalog Number	S-45-080-120-P6
Health Effect - Clinical Codes	Thrombosis (2100); Claudication (2550)
Date of Event	09/11/2016
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 claudication and thrombosis are listed in the supera instructions for use (ifu) as a known patient effects associated with the use of the device.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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.The other four supera devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that on (b)(6) 2016, 5 supera stents were implanted in the proximal popliteal to the superficial femoral artery (sfa) without reported issue.The patient was provided aspirin and plavix.On (b)(6) 2016, the patient presented to the hospital.The same leg containing the implanted supera stents was cold and painful.Per angiogram, a blood clot was noted in all 5 stents, a total occlusion.The patient was hospitalized and balloon angioplasty was performed using a drug eluting balloon.Tissue plasminogen activator (tpa) was provided overnight.The event resolved without sequela.There was no additional information 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: 5975417
• Report Number: 2024168-2016-06379
• Device Sequence Number: 18975198
• Product Code: NIP
• UDI-Device Identifier: 08975370026252
• UDI-Public: (01)08975370026252(17)170731(10)5081061
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/23/2016

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: 07/31/2017
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 5081061
• 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: 09/23/2016
• 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: 4 IMPLANTED SUPERA STENTS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 62