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

Catalog Number	S-45-120-120-P6
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery (sfa).A guide wire was advanced and pre-dilatation was performed with a balloon.The 4.5x120mm super self-expanding stent system (sess) was implanted.However, thrombus was generated in the target vessel due to poor adherence to the wall and the stent was displaced to the distal end.A snare device was used to remove the stent immediately and the clot subsequently disappeared on its own without surgical intervention.Another 5.5mm supera stent was implanted and completed the procedure.There was no adverse patient sequelae.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported patient-device incompatibility-wall apposition and the reported migration-stent were 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 identified no other incidents from this lot.The reported patient effect of thrombosis is listed in the supera peripheral stent system instructions for use (ifu) as potential adverse effects of peripheral percutaneous intervention.It is possible that during initial deployment the diameter of the stent used was inadvertently undersized for the size of the vessel; thus resulting in the reported patient-device incompatibility wall apposition and ultimately resulted in the reported stent migration; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility wall apposition and the reported stent migration cannot be determined.As there was no damage noted to the device during the inspection prior to use, it is likely that inadvertent mishandling resulted in the noted device damages (pinched sheath, separated tip jacket/inner member).The reported difficulties possibly caused/contributed to the reported patient effects; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.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: 18029941
• Report Number: 2024168-2023-11950
• Device Sequence Number: 6060184
• Product Code: NIP
• UDI-Device Identifier: 08717648226007
• UDI-Public: 08717648226007
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 02/28/2025
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 3032461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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: 7F GUIDING CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown