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

Catalog Number	S-55-150-120-P6
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa) with heavy calcification.The 5.5x150mm supera self expanding stent system (sess) was deployed and an unspecified balloon was used for post dilatation; however, the stent may have been fractured and elongated but there was no separation noted on angiography.The image was unclear due the heavy calcification.A portion of the stent remained in the target lesion, while a portion of the stent was in healthy tissue; therefore, an unspecified delivery catheter was introduced and another unspecified stent was implanted through the supera to treat the broken portion of the stent and the rest of the target lesion; however, the severe thrombosis was noted and was treated with intra-arterial lysis and the patient was hospitalized.The patient had a follow up on (b)(6) 2023.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 during deployment interactions with the heavily calcified anatomy and/or other devices during post dilatation resulted in the reported stretched-stent and the reported break-stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, the reported difficulties possibly caused/contributed to the reported patient effect; however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.The reported patient effect of thrombosis and stent strut fracture is listed in the supera peripheral stent system instructions for use as potential adverse events.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: 17512028
• Report Number: 2024168-2023-08698
• Device Sequence Number: 20859206
• Product Code: NIP
• UDI-Device Identifier: 08717648226168
• UDI-Public: 08717648226168
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 08/31/2023

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: 11/30/2024
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 2120861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown