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

Catalog Number	S-60-080-120-P6
Health Effect - Clinical Codes	Pain (1994); Claudication (2550)
Date of Event	01/03/2018
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.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 pain/claudication and occlusion are listed in the supera instructions for use as 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 6.0 x 100 mm supera device referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure on (b)(6) 2017 was performed to treat lesions located in the superficial femoral and popliteal arteries.There was mild tortuosity and mild calcification present prior to stenting.Two supera stents (6.0 x 80 mm and 6.0 x 100 mm) stents were deployed for treatment of the lesions.On (b)(6) 2018, the patient began experiencing pain at rest and claudication and it was confirmed that both supera stents had occluded.The patient is being reevaluated at this time; however, no treatment has been performed.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).

• 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: 7184626
• Report Number: 2024168-2018-00320
• Device Sequence Number: 1212748
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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: 09/30/2017
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 5102261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/16/2018
• 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
• Patient Age: 70 YR