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 Codes	Pain (1994); Thrombosis (2100)
Date of Event	07/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient and device codes were coded by the manufacturer.(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.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of thrombosis and pain are listed in the supera instructions for use as known potential patient effect.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional supera devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported that in-stent thrombosis was observed via angiography in the supera stents that were deployed on (b)(6) 2016.The stents were located in the superficial femoral artery and the popliteal.The procedure was successful and without issue.There was no record of existing thrombosis in the patient prior to stenting.The patient was experiencing pain at rest which led to the angiography which took place on (b)(6) 2016 revealing in-stent thrombosis.Thrombolysis was performed and on the following day a non-abbott stent was placed.The patient returned again approximately 1 month later with repeat in-stent thrombosis for which the patient was sent for surgery for an above the knee amputation.It was confirmed that the patient had not been compliant with his post-procedural medication.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: 7139874
• Report Number: 2024168-2017-10067
• Device Sequence Number: 1069733
• Product Code: NIP
• UDI-Device Identifier: 08975370026283
• UDI-Public: 08975370026283
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/21/2017

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-55-040-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/21/2017
• 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: STENT: SUPERA (X2)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 100