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

Catalog Number S-60-150-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Activation Failure (3270)

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

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a mildly calcified, mildly tortuous superficial femoral artery that is 90% stenosed.The lesion was prepped with two 5x200mm and 6x200mm armada 35 balloon at 8 to 12 atmospheres for 2-3 minutes.The 6.0x150mm supera self-expanding stent system (sess) was 2/3 into deploying the stent when it was noted the tip of the delivery catheter separated.The stent was removed with the delivery system under fluoroscopy.An attempt was made to remove the separated tip; however, it was unsuccessful as the unspecified guide wire was not able to push the separated tip as it was firmly entrenched.Therefore, the tip of the delivery system remained embedded, and surgery was performed to remove the separated tip.There was no adverse patient sequela and no clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

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.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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, it is possible that during stent deployment interaction with the mildly calcified, mildly tortuous and 90% stenosed anatomy and/or inadvertent mishandling resulted in the reported tip material separation/noted tip jacket and inner member separations; thus resulting in the reported activation failure and reported difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.The noted shaft kink likely occurred due to handling or during packing for return analysis.The treatment(s) appears to be related to the operational context of the procedure as reportedly an attempt was made to remove the separated tip; however, it was unsuccessful.Therefore, surgery was performed to remove the separated tip.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a mildly calcified, mildly tortuous superficial femoral artery that is 90% stenosed.The lesion was prepped with two 5x200mm and 6x200mm armada 35 balloon at 8 to 12 atmospheres for 2-3 minutes.The 6.0x150mm supera self-expanding stent system (sess) was 2/3 into deploying the stent when it was noted the tip of the delivery catheter separated.The stent was removed with the delivery system under fluoroscopy.An attempt was made to remove the separated tip; however, it was unsuccessful as the unspecified guide wire was not able to push the separated tip as it was firmly entrenched.Therefore, the tip of the delivery system remained embedded, and surgery was performed to remove the separated tip.There was no adverse patient sequela and no clinically significant delay was reported.No additional information was provided.

• 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: 17946477
• MDR Text Key: 325794860
• Report Number: 2024168-2023-11415
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: 08717648211843
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 1101161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Supplement Dates Manufacturer Received: 01/15/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention