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

Model Number	S-60-120-120-P6
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/30/2025
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 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 during device removal inadvertent interaction between the deployed stent and the device tip resulted in the reported stent migration.Further manipulation of the compromised device ultimately resulted in the reported tip material separation.As reported, an additional stent was advance to embed the floating tip to the vessel wall in the popliteal and additional balloon catheter was used to fully post dilate the implanted stent and the target lesion and the procedure was concluded.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 performed to treat a 70% stenosed lesion in the popliteal artery.The vessel was predilated using a 4x150mm and 6x200mm non-abbott balloon, with no atherectomy noted.Following this a 6.0x120mm supera peripheral self-expanding stent (ses) was advanced through a 6fr 45cm sheath and over a 018 command guidewire (gw) to the lesion and deployed at the the target lesion.It was noted that the stent was fully deployed with the thumb slide advanced to the distal portion of the handle with the distal end of the sheath being located at a substantial distance away with proximal ended of the stent in the popliteal and the distal end of the sheath in the common femoral artery.However following withdrawal under fluoroscopy with the handle in the locked position, it was noted that the stent migrated to the superficial femoral artery (sfa) and was located within a stent that was previously implanted during the procedure.In additional the cone tip of the delivery catheter was noted to be separated and floating in the sfa.Therefore an additional stent was advance to embed the floating tip to the vessel wall in the popliteal and additional balloon catheter was used to fully post dilate the implanted stent and the target lesion and the procedure was concluded.There were no adverse patient sequela nor clinical delay reported.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: 22288168
• Report Number: 2024168-2025-06299
• Device Sequence Number: 12878496
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: (01)08717648211836(17)270228(10)5030361
• 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
• 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): 06/18/2025

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 Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 5030361
• 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: 05/30/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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: GUIDEWIRE: 18 COMMAND GUIDEWIRE; SHEATH: 6FR 45CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG