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

Model Number	S-65-150-120-P6
Medical Device Problem Codes	Material Separation (1562); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, mildly tortuous popliteal artery lesion with 80% restenosis.A 6.5 x 150 mm supera self-expanding stent was implanted.However, the thumbslide was not retracted, and levers were not locked.Therefore, the stent became extremely elongated, and the nose cone was separated from the delivery system after removing the device from sheath.A snare was used to remove the separated tip from the distal popliteal artery.An additional device was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported stretched stent was unable to be replicated in a testing environment due to the condition of the returned device (stent previously deployed and not returned).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.Reportedly, after the supera self-expanding stent was implanted, the thumbslide was not retracted, and levers were not locked.It should be noted that the supera peripheral stent system instructions for use (ifu) states: prior to removal of the delivery system, ensure the supera stent is completely deployed, the thumb slide is retracted the system lock and deployment lock are locked (in the path of the thumb slide).The investigation determined the reported difficulties appear to be related to deviation of the ifu and subsequent circumstances of the procedure as it is likely that failing to retract the thumbslide and re-lock the levers resulted in the tip of the supera to not be fully retracted back into the distal sheath, resulting in the tip of the device to be caught on the deployed stent during removal; thus inadvertently elongating the stent and separating the nose cone from the delivery system, ultimately resulting in the reported stretched stent and reported/noted material separation.Manipulation of the compromised device during removal likely resulted in the noted device damages (bunched and kinked tip jacket, bent tip).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.H6: medical device problem code 2017 - failure to follow steps / instructions.

• 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: 25096163
• Report Number: 2024168-2026-01832
• Device Sequence Number: 14722254
• Product Code: NIP
• UDI-Device Identifier: 08717648226328
• UDI-Public: (01)08717648226328(17)271130(10)5120161
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/06/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: S-65-150-120-P6
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 5120161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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