MAUDE Adverse Event Report: ABBOTT VASCULAR INC. SUPERA; Stent, Superficial Femoral Artery

Model Number	S-65-120-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Subsequent to the initial report being filed, it was reported that during removal of the 6.5x120mm supera self-expanding stent system (sess), the partially deployed stent became fully deployed while inside the introducer sheath.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was able to be confirmed as the stent was previously deployed and returned.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.The reported material twisted / bent was unable to be confirmed.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 the circumstances of the procedure as it is likely that interaction with the heavily calcified, 100% stenosed anatomy resulted in the stent to not adhere to the vessel wall, thus resulting in the reported/noted partial stent activation failure.It is likely that during removal, inadvertent interaction with the anatomy and/or other devices resulted in the stent to become fully deployed in the introducer sheath, thus resulting in the reported/noted activation failure ¿ removed deployed, reported material twist/bent, and reported difficult to remove.Further manipulation of the compromised device in attempts to remove the device likely resulted in the noted material separation of the tip jacket from the ratchet stem.The treatment(s) appears to be related to the operational context of the procedure.There was no damage noted to the device during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.

• Brand Name: SUPERA
• Common Device Name: Stent, Superficial Femoral Artery
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 -280
• Manufacturer (Section G): ABBOTT VASCULAR, Reg # 2024168; 26531 ynez road; temecula CA 92591 -462
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591--462 ; +1(951)914-5259
• MDR Report Key: 50145144
• Report Number: 2024168-2026-03086
• Device Sequence Number: 10687226
• Product Code: NIP
• UDI-Device Identifier: 08717648226304
• UDI-Public: (01)08717648226304(17)270831(10)5092661
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: S-65-120-120-P6
• Device Catalogue Number: S-65-120-120-P6
• Device Lot Number: 5092661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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
• Patient Sex: Male
• Patient Weight: 167 LB
• Patient Race: White