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

Catalog Number S-60-150-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)

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

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The deployment issue, difficulty removing and stent elongation was not confirmed.The tip detachment was confirmed.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 did not indicate a lot specific product issue.The supera instructions for use states: should unusual resistance be felt at any time during stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.In this case, circumstances related to the deployment issue resulted in the need for further intervention and force in the attempt to remove the device.The investigation determined the reported difficulties were due to case circumstances.It is likely that the distal shaft was entrapped or restricted within the anatomy such that the ratchet was unable to engage the remainder of the stent for full deployment resulting in difficulty removing, stent elongation and tip detachment.The damage noted to the distal sheath may also indicate that the distal sheath was entrapped contributing to the deployment issue.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 superficial femoral artery (sfa) with no tortuosity and moderate calcification.A 6.0x150 mm supera self expanding stent system (sess) was advanced via the anterior tibial artery.On deploying the stent, the last 2cm of the stent failed to deploy.The thumbslide would move freely but the ratchet would not catch anymore stent to deploy.After repeated attempts to deploy the stent using the thumbslide, the handle was manually broken to attempt to deploy the stent without the handle.The stent did not deploy further.Stent elongation was noted when force was applied to withdraw the sess against resistance from the anatomy.As a result, posterior tibial artery access was gained and a 6.0 x 200 mm armada 18 percutaneous balloon angioplasty (pta) balloon catheter was advanced distal to the stent.While the balloon was inflated distal to the stent, the sess was removed with force and the stent fully deployed at the target lesion.A tip separation of the sess occurred.The separated tip remained in the diseased lesion distal to the stent.An additional unspecified supera stent was deployed distally via posterior tibial artery access with slight overlap to the implanted stent.The additional stent crushed the separated tip of the sess against the diseased vessel wall and successfully completed the procedure.The procedure was delayed by 60 minutes.There was no reported adverse patient sequela.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: 7794466
• MDR Text Key: 117564938
• Report Number: 2024168-2018-06344
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 8030761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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