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

Model Number	S-55-040-120-P6
Medical Device Problem Codes	Entrapment of Device (1212); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure performed was to treat a left tibioperoneal trunk that is 90% stenosed.The vessel was prepped with an unspecified 5x40mm balloon inflated to 6 atmospheres.A 5.5x40mm supera peripheral self-expanding stent (ses) was deployed; however, when attempting to remove the supera delivery system under fluoroscopy, resistance was felt.The stent was observed to be contained in the sheath and could not be removed from the sheath.The stent was withdrawn slowly by pulling the sheath back, and then cutting the sheath outside the body, piece by piece to remove the stent.The lesion was re-wired and exchanged with a 6x11 sheath which was exchanged again with a 6x45 sheath.A new supera and was used successfully to complete the procedure.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported activation failure could not be replicated in a testing environment due to the condition of the returned device.The reported entrapment of device could not be replicated in a testing environment as it was based on operational context.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 history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported complaints and unexpected medical intervention appear to be related to operational context.In this case, it is likely that the stent was inadvertently deployed onto the introducer sheath such that it became entrapped, and difficulty was experienced when attempts to remove the supera delivery system.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: 21928422
• Report Number: 2024168-2025-04422
• Device Sequence Number: 18410347
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: (01)08717648226069(17)260930(10)4102861
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 07/01/2025

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 Expiration Date: 09/30/2026
• Device Model Number: S-55-040-120-P6
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 4102861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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