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

Catalog Number S-65-150-120-P6

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/07/2018

Event Type  Injury  

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 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
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7322462
• MDR Text Key: 101831333
• Report Number: 2024168-2018-01650
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: 08975370026399
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 49