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

Catalog Number S-50-040-120-P6

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

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

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - failure to follow steps.

Event Description

It was reported that the procedure was to treat an 80% stenosed lesion in the moderately calcified right popliteal artery.The lesion was prepped with a 5mm balloon to nominal pressure.A 5.0x40mm supera self-expanding stent system (sds) was advanced without resistance over a command guidewire; however, on deployment the stent did not fully deploy, and the tip broke from the shaft.The entire sds including the partially deployed stent and separated tip was retrieved from the patient by simply pulling the system through the 6f sheath against resistance.The delivery system was removed under fluoroscopy.The procedure was completed at this point.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device (stent returned deployed).The reported difficult to remove 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 identified no other incidents from this lot.Reportedly, the entire sds including the partially deployed stent and separated tip was retrieved from the patient by simply pulling the system through the 6f sheath against resistance.It should be noted that the supera peripheral stent system instructions for use, states: precaution: should unusual resistance be felt at any time during stent system removal, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Although it was noted the physician used force in the attempts to remove the compromised device, this was due to the anatomy and/or other devices interacting with the partially deployed stent, therefore the force applied during removal of the device seemed to be a reasonable clinical response to the difficulties.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the distal sheath of the delivery system was entrapped or bent in the moderately calcified and 80% stenosed anatomy and/or other devices such that the ratchet was unable to properly/fully engage the stent resulting in the reported deployment difficulty/activation failure.Interaction and/or manipulation of the device resulted in the noted device damages (multiple distal sheath bends/kinks, multiple shaft bends) likely contributing to the reported deployment difficulty/activation failure and ultimately resulting in the reported tip separation/noted inner member separation; thus resulting in the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18572684
• MDR Text Key: 333619147
• Report Number: 2024168-2024-01074
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: 08717648211737
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 3062961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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: COMMAND GUIDE WIRE
• Patient Age: 78 YR
• Patient Sex: Female