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

Model Number S-50-080-120-P6

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 10/21/2021

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified left superficial femoral artery (sfa) that is 100% stenosed.Using a crossover technique from the right sfa a 5.0x40mm supera self-expanding stent system (sess) was deployed at the distal part of the lesion.A 5.0x80mm supera sess was attempted to be deployed mid lesion; however, resistance was noted with the thumbslide and the tip of the supera stuck to the previous implanted stent.Excessive force was applied and the tip separated.The separated tip was retrieved and device was removed form the anatomy.A non-abbott stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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.Reportedly, the 5.0x80mm supera sess was attempted to be deployed mid lesion; however, resistance was noted with the thumbsilde and the tip of the supera stuck to the previous implanted stent.Excessive force was applied and the tip separated.It should be noted that the supera peripheral stent system instructions 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, the stent was partially deployed and the force was required to try to release the stent.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 100% stenosed anatomy resulted in the ratchet being unable to properly engage and release the stent from the delivery system thus resulting in reported activation failure/ deployment failure and the reported mechanical jam.Manipulation as the tip of the supera stuck to the previous implanted stent resulted in the reported difficult to remove and ultimately resulted in the reported material separation.The treatment appears to be related to the operational context of the procedure as the separated tip was retrieved and device was removed from the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12813707
• MDR Text Key: 281972331
• Report Number: 2024168-2021-10342
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 1011861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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: SUPERA STENT (5.0X40MM)
• Patient Outcome(s): Required Intervention