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

Catalog Number	S-60-060-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the udi is unknown because the part/lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional steelcore 18 device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).The supera self-expanding stent system (sess) was attempted to be advanced onto the steelcore 18 guide wire when the stent system got stuck and sheared the guide wire causing the guide wire to peel.The devices were removed as a single unit.There was nothing left in the patient.Another steelcore guide wire and supera stent were used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.
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.It is possible that the devices were not coaxially aligned and/or a buildup/coagulation of blood/contrast on the guide wire resulted in the reported difficult to advance and difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4 - catalog # and lot # updated.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to advance and the reported difficult to remove were able 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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the steelcore 18 guide wire resulted in compromising the guidewire flush port; thus resulting in the reported difficult to advance and the reported difficult to remove.Inadvertent mishandling resulted in the noted shaft kink likely causing/contributing to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9- device available for evaluation updated from ¿no¿ to ¿yes¿.H3 - device returned to mfg? updated from ¿no¿ to ¿yes¿.H6 - type of investigation code 4115 removed; investigation findings code 213 removed; investigation conclusions code 67 removed.Component code 525 added; type of investigation code 10 added; investigation findings code 114 added; investigation conclusions code 4311 added.H10 - additional mfg narrative: revised.

• 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: 17453953
• Report Number: 2024168-2023-08437
• Device Sequence Number: 7269917
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: 08717648211805
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 1123061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 12/08/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/22/2023; 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• 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: STEELCORE GUIDE WIRE
• Patient Sex: Unknown