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

Catalog Number	S-65-150-120-P6
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 supera instruction for use states that the device is indicated for use in the superficial femoral artery (sfa) and / or proximal popliteal artery.It could not be determined if using the supera in the iliac contributed to the reported difficulties.Based on the reported information, it is likely that the introducer sheath was positioned too close to the supera stent during deployment, contributing to the reported difficulties.The investigation determined that the difficulties were due to operational context.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient underwent a peripheral procedure to treat a target lesion in the moderately calcified and tortuous iliac artery.During deployment, the supera stent deployed in the sheath and pinned the nosecone.The stent delivery system was pulled and the nosecone separated.The stent was fully deploy at the target lesion without further difficulty.A snare was advanced to capture the separated nosecone; however, the nosecone could not be pulled into the sheath.An unspecified covered stent was deployed to crush the nosecone to the vessel wall, proximal to the deployed supera stent and in the lesion that was planned to be stented.There was no clinically significant delay and no adverse patient sequelae.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: 7322462
• Report Number: 2024168-2018-01650
• Device Sequence Number: 110638
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: 08975370026399
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 7091361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/07/2018
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 49