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

Model Number S-50-100-120-P6

Device Problems Stretched (1601); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 an arteriosclerotic occluded long lesion located in the superficial femoral artery (sfa).Pre-dilatation was performed with a 5x100 armada 18 balloon for 3 minutes at 12 atmospheres.Two supera were selected to treat the lesion.The first 6x80mm supera stent was released in the distal part of the lesion without any issue.When deploying the second 5x100mm supera stent in the proximal sfa, half of the supera stent was released as the system locking mechanism became stuck.The physician applied force to pull the delivery sheath to release the stent.After several attempts, the stent was completely released.However the 5x100mm supera stent was severely compressed and stretched within the vessel.No further intervention or actions were performed and the procedure was completed.The delivery system was removed under fluoroscopy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and functional analysis was performed on the returned device.The reported deployment difficulty and resistance with the thumbslide were not confirmed.The reported stent damage was unable to be confirmed as the stent was not returned.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 reported from this lot.The supera instruction for use (ifu) states: ¿should unusual resistance be felt at any time during stent system advancement or stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.¿ in this case, excess force seemed to be a reasonable clinical response to the difficulties encountered.The investigation was unable to determine a cause for the reported difficulties.Based on the reported information, it is possible that the distal sheath of the supera delivery system was restricted or bent in the vessel causing difficulty advancing the thumbslide and partial stent deployment.Additionally, removing the delivery system with force while the stent is partially deployed likely caused the reported stent damage and stretching.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.

• 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: 12499796
• MDR Text Key: 273595703
• Report Number: 2024168-2021-08310
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: S-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 1051961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 40MM COOK SHEATH; 6X80MM SUPERA STENT