MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 42055120-120

Device Problems Entrapment of Device (1212); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the left superficial femoral artery that was both moderately calcified and tortuous and 70% stenosed.The supera stent system was advanced to the lesion without reported issue.During attempted deployment, the lock could not be rotated to the unlock position and while forcefully trying to unlock, the knob was unlocked, but the stent was not deployed.The entire delivery system, including the stent, was extracted surgically.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure and the reported mechanical jam were unable to be replicated in a testing environment due to the condition of the returned device (received with stent deployed).The reported entrapment of device was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.It is possible that the distal sheath of the delivery system was entrapped or bent in the anatomy and/or interaction/manipulation of the device resulted in the noted device damages (bunched inner member, bent outer sheath, kinked tip lumen) resulting in reported mechanical jam (unable to rotate deployment lock) thus resulting in the reported activation failure/ deployment failure; however, without any further case details this could not be confirmed.Additionally, without any further case details a conclusive cause for the reported entrapment cannot be determined.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.The noted cut distal sheath and the treatments appear to be related to the operational context of the procedure as reportedly the whole delivery system including the stent was extracted surgically.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12301829
• MDR Text Key: 265838770
• Report Number: 2024168-2021-07027
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 42055120-120
• Device Lot Number: 0121061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 74