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); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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 interaction with the heavily calcified, 70% stenosed anatomy and with the implanted 6x150 mm supera self-expanding stent (ses) in the distal lesion resulted in the tip getting caught in the junction of the two supera stents.Manipulation of the compromised device in attempts to deploy the stent likely resulted in the reported tip material separation.Further manipulation of the compromised device during withdrawal prior to stent deployment ultimately resulted in the reported stretched stent.As reported, surgery was performed to retrieve the separated tip and explant both stents.There was a clinically significant delay in the procedure.Based on the 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 de novo, heavily calcified, moderately tortuous right common iliac artery lesion with 70% stenosis.A 6x150 mm supera self-expanding stent (ses) was implanted without issue in the distal lesion.A 6x120 mm supera ses was also advanced to the target lesion; however, during deployment, the tip got caught at the junction of the two supera stents, causing the tip to separate within the vessel.After detecting the tip separation, the delivery system was withdrawn prior to stent deployment, causing stretching and malformation of the stent.Surgery was performed to retrieve the separated tip and explant both stents.There was a clinically significant delay in the procedure.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: 25318977
• Report Number: 2024168-2026-02167
• Device Sequence Number: 5291862
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: (01)08717648211836(17)270331(10)5042461
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 5042461
• 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: 05/13/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: STENT: 6X150 MM SUPERA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown