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

Catalog Number 42055080-120

Device Problems Difficult or Delayed Activation (2577); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2020

Event Type  malfunction  

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 superficial femoral artery that was moderately calcified and mildly tortuous.After lesion preparation, the supera stent system was advanced to the lesion and stent deployment initiated; however, the stent did not fully deploy and would not release from the device.The supera stent system, including the stent were removed without issue.There was no reported adverse patient effect and no clinically significant delay in the procedure.A new supera stent was implanted, without issue, to complete the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment difficulty and partial stent deployment were not confirmed as the stent was not returned and had already been fully deployed.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 complaints.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath of the delivery system was entrapped or bent within the anatomy preventing the ratchet from engaging the stent during the final deployment stroke; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10862731
• MDR Text Key: 217344029
• Report Number: 2024168-2020-09685
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 42055080-120
• Device Lot Number: 0012261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1