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); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a pre-existing dissection in the superficial femoral artery (sfa) with 80% stenosis.The 6 x 120 mm supera self expanding stent system (sess) was advanced to the lesion and during deployment the stent elongated into the sheath and release of the stent was unable to be activated.The nose cone separated.The sheath and a non-abbott implant were removed and a snare was used to retrieve the nose cone.The case was delayed in order to retrieve the nose cone.Non-abbott stents were used to complete the procedure.No additional information was provided.
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 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 during stent deployment, the introducer sheath was too close and the stent inadvertently deployed/elongated in the introducer sheath, ultimately resulting in the reported activation failure.Further manipulation in attempts to remove the compromised device likely resulted in the reported material separation of the nose cone/tip.As reported by the account, the case was delayed and a snare was used to retrieve the nose cone.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.

• 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: 25222350
• Report Number: 2024168-2026-02055
• Device Sequence Number: 9792626
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: (01)08717648211836(17)270930(10)5102161
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/19/2026

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: 5102161
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2025
• 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: 014 COMMAND ES GUIDE WIRE; 6FR 45 CM PINNACLE SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown