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

Model Number	S-50-080-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2024168-2021-10342
• Device Sequence Number: 4777861
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: 08717648211751
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPERA STENT (5.0X40MM)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown