MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	S-55-040-120-P6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in an article that an 86-year-old woman presented with intermittent claudication after 6 months of supera stent implantation.Ultrasonography demonstrated popliteal artery occlusion secondary to supera stent fracture.Fluoroscopy revealed that the stent had fractured at the site closest to the artificial knee joint and might have been in contact with a vessel.In addition, the popliteal artery was slightly deviated medially in the p2 segment, suggesting popliteal artery entrapment syndrome.Because additional stenting was considered a risk for further stent failure, it was decided to complete endovascular treatment with balloon angioplasty alone and then bypass surgery.No additional information was provided.Details are listed in the article titled, "early supera stent fracture after treatment of popliteal artery occlusion caused by artificial knee joint: a case report".
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.It is possible that bending at the artificial knee joint and/or stress/fatigue/repetitive movement due to anatomical conditions resulted in the reported stent break; however, this could not be confirmed.The investigation determined a conclusive cause for the reported stent break cannot be determined.The reported difficulties possibly caused/contributed to the reported patient effects, however a conclusive cause and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4- the udi is not known as the part and lot number were not provided.Attachment article titled, "early supera stent fracture after treatment of popliteal artery occlusion caused by artificial knee joint: a case report".
Additional Manufacturer Narrative
Correction: a4: patient weight added.

• Brand Name: SUPERA
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 21995773
• Report Number: 2024168-2025-04876
• Device Sequence Number: 19911428
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: (01)08717648226069(17)240831(10)2090161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: S-55-040-120-P6
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 2090161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6.0X40MM SUPERA
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 49 KG