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

Model Number	S-50-100-120-P6
Medical Device Problem Codes	Stretched (1601); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
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.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the 30-40% stenosed anatomy resulted in the stent not being fully deployed from the delivery sheath resulting in the stent being inadvertently retracted with the delivery sheath; thus resulting in the reported stretched stent and the reported activation failure.As reported, a 5x80mm supera stent was used to treat the target lesion and also overlapped the stent in the mid sfa to ensure the stent was secured in the unintended location.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.
Event or Problem Description
It was reported that the procedure was to treat a 30-40% stenosed lesion in the right popliteal artery.After thrombectomy was performed, the 5x100mm super self-expanding stent system (sess) was advanced to the target lesion.Initially, the stent would not release upon advancing the thumb slide.However, the stent was ultimately released from the delivery sheath.But then during removal of the delivery sheath under imaging the stent was noted to being retracted with the delivery sheath.The stent was pulled to the mid superficial femoral artery (sfa), where the stent became implanted slightly stretched; however, still partially in the target lesion and partially in healthy tissue.A 5x80mm supera stent was used to treat the target lesion and also overlapped the stent in the mid sfa to ensure the stent was secured in the unintended location.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.

• 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: 23587827
• Report Number: 2024168-2025-11596
• Device Sequence Number: 13156205
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: (01)08717648211768(17)260731(10)4082761
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 07/31/2026
• Device Model Number: S-50-100-120-P6
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 4082761
• 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: 10/24/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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: .018 COOK ROADRUNNER GUIDE WIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown