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

Model Number	S-60-060-120-P6
Medical Device Problem Codes	Material Separation (1562); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separations were able to be confirmed.The reported mechanical jam was unable to be confirmed.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device (stent previously deployed).Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.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 90% stenosed and steep anatomy resulted in preventing the shaft lumens from moving freely; thus resulting in the reported mechanical jam and the reported activation/deployment failure.Interaction/manipulation of the compromised device resulted in the reported tip and shaft material separations/noted tip/tip lumen/tip jacket material separations.As reported, the nose cone, partially deployed stent, and separated portions were retrieved from the patient anatomy via cut down with nothing remaining in the patient and an unspecified stent was used to complete the procedure.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 performed was to treat a popliteal and superficial femoral artery that is 90% stenosed.An unspecified 5mm balloon was used to prepare the vessel at nominal pressure for 2 minutes.Halfway during the deployment, the 6.0x60mm supera self-expanding stent would not advance when moving the thumbslide.The deployment lock and stent lock were both in the open position with the stent partially deployed, when both the nose cone and shaft broke off in the patient.The nose cone, partially deployed stent, and separated portions were retrieved from the patient anatomy via cut down with nothing remaining in the patient.An unspecified stent was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in 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: 22925718
• Report Number: 2024168-2025-09261
• Device Sequence Number: 9235949
• Product Code: NIP
• UDI-Device Identifier: 08717648211805
• UDI-Public: (01)08717648211805(17)261031(10)4111361
• 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
• 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): 08/29/2025

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-60-060-120-P6
• Device Catalogue Number: S-60-060-120-P6
• Device Lot Number: 4111361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown