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

Catalog Number	S-55-120-120-P6
Health Effect - Clinical Codes	Pain (1994); Claudication (2550); Diminished Pulse Pressure (2606)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.Factors that may contribute to stent deformation, or collapsed stent include, but are not limited to, processing and/or handling in manufacturing, lesion characteristics, procedural technique, product size selection, severe torqueing or kinking of stent (material stress/ fatigue) or interaction with the accessory devices, lesion and/or anatomy.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The reported patient effects of pain and claudication are known potential patient effects as listed in the supera instructions for use (ifu).Based on the case information and related record review, a cause for the collapsed stents could not be determined.The subsequent patient effects and additional therapy, treatment with medication and hospitalization appear to be related to case circumstances.There is no indication of a product quality issue.The other two supera devices are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that on (b)(6) 2017, three supera stents were implanted in the patient's right upper leg.On (b)(6) 2017, the patient experienced severe right leg pain and a cold and blue right leg.Imaging was performed and per physician, all three stents had collapsed.There was no reported stenosis and no reported thrombosis.Medications were provided and, on (b)(6) 2017, another percutaneous intervention was performed as treatment, implanting new unspecified stents within that area.The patient is feeling better but there is still pain.There was no additional information provided regarding this issue.

• 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: 6598897
• Report Number: 2024168-2017-04588
• Device Sequence Number: 16299828
• Product Code: NIP
• UDI-Device Identifier: 08975370026320
• UDI-Public: (01)08975370026320(17)180131(10)6021261
• Combination Product (Y/N): N
• 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: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/30/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 6021261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/30/2017
• 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: 57 YR
• Patient Weight: 78