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

Model Number	S-45-080-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the popliteal artery was prepared with a non-abbott 5x4 mm balloon dilatation catheter inflated to 14 atmospheres for 120 seconds.Atherectomy was performed in the stenotic and calcified vessel.After deployment of the supera stent, it was confirmed under fluoroscopy that the stent emerged from the sheath and was fully released.There was no waist noted on the deployed stent or proximal end of the lesion.The thumb slide was fully retracted to the start position and both the system and deployment levers were locked prior to removal of the self-expanding stent system (sess) under fluoroscopy.The physician rotated the system lock and the deployment lock into the locked position.Resistance was met while removing the sess from the anatomy.Once the supera was pulled out of the body, the physician noticed a piece of the supera nose cone was lodged in the introducer sheath while fluoroscopy was active.Because of this, they pulled the rest of the introducer sheath and sess out of the body.All of the supera stent delivery system was removed from the patient anatomy, including all segments of the separated section.A new introducer sheath was inserted to continue the procedure.Although a second stent was deployed proximal, the physician had planned on deploying two stents.No patient consequences were reported.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
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventive 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 circumstances of the procedure as it is likely that after deployment of the supera stent during device removal inadvertent interaction with the introducer sheath resulted in the reported difficult to remove.Manipulation of the compromised device ultimately resulted in the reported tip material separation/noted tip, tip lumen and tip jacket separations.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.Corrections: d3 - mfr establishment name, address 1, city, postal code: updated.

• 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: 24037097
• Report Number: 2024168-2026-00204
• Device Sequence Number: 13076458
• Product Code: NIP
• UDI-Device Identifier: 08717648225963
• UDI-Public: (01)08717648225963(17)270930(10)5100261
• 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
• 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,Followup
• Report Date (Section B): 02/02/2026

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-45-080-120-P6
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 5100261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2025
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: Black Or African American