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

Model Number	S-45-100-120-P6
Medical Device Problem Codes	Material Separation (1562); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/29/2025
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 query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined.The subsequent treatment is related to the circumstance of the procedure.It was reported the vessel was heavily calcified, the physician used compression to deliver the stent, and that the tip came off when the stent was released.These factors suggest that the heavy calcification prevent the vessel from full diameter which would cause the stent to elongate during deployment.The physician used compression to reduce the elongation.It is possible the tip became caught in the stent due to the compression applied to minimize elongation and the separated during the final release stroke to deploy the stent.This would also explain the inability to retrieve the tip.Additionally, the tip separated at the same time of the stent release this indicates that the stent elongation was likely enough to keep the stent from full deployment after the thumb slide was unlocked to fully deploy the stent.In this condition the stent was likely captured between the sheath and the tip, causing the tip to separate when the device was pulled back; however, these cannot be confirmed.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 heavily calcified superficial femoral artery (sfa).The 4.5x100mm supera self-expanding stent was deployed with difficulty as a decent amount force was use to keep the supera compressed during deployment.When attempting to remove the delivery system under fluoroscopy the tip of the delivery system separated.A non-abbott stent was used to embed the tip in the sfa.There was no adverse patient sequela and no 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: 23599474
• Report Number: 2024168-2025-11628
• Device Sequence Number: 9381392
• Product Code: NIP
• UDI-Device Identifier: 08717648225987
• UDI-Public: (01)08717648225987(17)270731(10)5081961
• 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
• Device Implanted Year: 2025
• 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): 11/19/2025

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-45-100-120-P6
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 5081961
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown