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

Catalog Number S-50-080-120-P6

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual inspection was performed on the returned device.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 deployment issue and difficulty removing was unable to be confirmed as the stent had already been fully deployed.The tip separation was confirmed.It is likely that the distal sheath was bent or entrapped within in the anatomy such that the ratchet was unable to properly engage the stent causing the partial deployment.The investigation determined the reported difficulties were likely related to circumstances of the procedure.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 procedure was to treat a lesion in the popliteal artery.The vessel was pre-dilated with a 5.0 mm drug coated balloon.A 6fx45cm guide sheath was used.During deployment of the 5 x 80 mm supera stent system the stent did not fully deploy, it partially deployed.The device was retracted back into the sheath and resistance was felt with the sheath.The nose cone (tip) broke off inside the sheath when attempting to remove the device.The device, tip, and sheath were removed together as a single unit.The decision was made to discontinue the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.There was no additional information 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: 7435936
• MDR Text Key: 105693788
• Report Number: 2024168-2018-02833
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 7081461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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
• Treatment: SHEATH: 6FX45CM DESTINATION
• Patient Age: 58 YR
• Patient Weight: 82