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

Catalog Number 42055200-120

Device Problems Difficult to Advance (2920); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.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 heavily tortuous, heavily calcified de novo left superficial femoral artery that was 99% stenosed.Via a retrograde puncture approach on the right common femoral artery (cfa) a crossover sheath was taken over an amplatz wire.Then the lesion was crossed with a command es wire and predilated the lesion with a 5.5x200mm armada 18 balloon and a 6mm balloon at nominal pressure.A 5.5x200mm supera stent was prepared per the instructions for use.The supera was advanced over the command es wire and positioned over the lesion.There was noted resistance when advancing the supera to the lesion but it is unknown what it met resistance with, and the supera ultimately reached the lesion.Deployment of the supera was initiated and the system lock was opened (although noted initially as difficult to unlock) and the thumbslide progressed to the most distal position (although noted initially as difficult to slide) but the last portion of the supera stent was unable to be deployed.It was decided to remove the entire system by progressing the sheath over the stent and removing the entire device.The delivery system was not removed under fluoroscopy.Another 5.5x200mm supera stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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.As there was no reported 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 resistance was met with the heavily tortuous, heavily calcified and 99% stenosed anatomy resulting in the reported difficult to advance and the reported physical resistance (unlocking system lock, difficult to slide thumbslide).Additionally, during stent deployment resistance with the heavily tortuous, heavily calcified and 99% stenosed anatomy likely resulted in the ratchet being unable to properly engage and fully release the stent from the delivery system; thus resulting in reported activation/deployment failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - device status changed from 'yes to no.

Manufacturer Narrative

The device was returned for analysis.The reported activation/deployment failure and the reported difficult to advance were unable to be replicated in a testing environment due to the condition of the returned device.The reported physical resistance/sticking (thumbslide) and the reported physical resistance/sticking (difficult to use) were unable to be confirmed.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.As there was no reported 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 interaction with the heavily tortuous, heavily calcified and 99% stenosed anatomy resulted in the reported difficult to advance and the reported physical resistance (unlocking system lock, difficult to slide thumbslide).Additionally, during stent deployment interaction with the heavily tortuous, heavily calcified and 99% stenosed anatomy likely resulted in the ratchet being unable to properly engage and fully release the stent from the delivery system; thus resulting in the reported activation/deployment failure.Inadvertent mishandling likely resulted in the noted device damages (stretched/kinked inner member, multiple shaft bends) which likely contributed to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9/h3: return status updated.Subsequent to filing the initial reports, the device was received.

• 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: 14311945
• MDR Text Key: 290959582
• Report Number: 2024168-2022-04945
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 42055200-120
• Device Lot Number: 1121561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2021
• 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: 7F BALKEIN CROSSOVER SHEATH; AMPLATZ WIRE; COMMAND ES WIRE