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

Model Number	S-60-100-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure performed was to treat a moderate to heavy, mildly tortuous superficial femoral artery that is 100% stenosed.After deployment of a 6.0x100mm supera self-expanding stent (ses), when attempting to remove the supera delivery system the tip of the delivery system separated and was snared out.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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.Reportedly, the system lock and deployment lock were not rotated into the lock position and the stent appeared to not be completely deployed when pulled back into the sheath.It should be noted that the supera peripheral stent system instructions for use (ifu) states: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.The deviation of the ifu appears to have caused/contributed to the reported difficulties.Additionally, reportedly when attempting to remove the supera delivery system, resistance was noted at the distal sheath and force was applied.It should be noted that the ifu also states: precaution: should unusual resistance be felt at any time during stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.The force applied during removal of the device seemed to be a reasonable clinical response to the reported difficulties.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that failing to rotate the system lock and deployment lock into the lock position resulted in during removal the tip of the device becoming inadvertently caught on the deployed stent resulting in the reported difficult to remove.Manipulation of the compromised device using force ultimately resulted in the reported tip material separation.As reported, an attempt was made to snare out the separated tip however the tip was embedded in a previously occluded peroneal.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 - excessive force, failure to follow steps / instructions.
Event or Problem Description
Subsequently after the initial report had already been filed, during deployment of the supera ses, the system lock and deployment lock were not rotated into the lock position and the stent appeared to not be completely deployed when pulled back into the sheath.The stent was confirmed to be implanted at the lesion.When attempting to remove the supera delivery system, resistance was noted at the distal sheath and force was applied.The tip of the delivery system separated and an attempt was made to snare out the separated tip, however the tip was embedded in a previously occluded peroneal.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: 22072547
• Report Number: 2024168-2025-05328
• Device Sequence Number: 8711793
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: (01)08717648211829(17)260930(10)4101561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/02/2025

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-60-100-120-P6
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 4101561
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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 Age: 66 YR
• Patient Sex: Female