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

Model Number	S-60-150-120-P6
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
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 review of the complaint history identified no other similar complaints from this lot.It was reported by the account that the thumb slide was not fully retracted to the start position and both the system and deployment levers were not locked prior to removal.Resistance was felt during removal and the distal end of the delivery catheter was noted to be separated.It should be noted that the , supera, fda, electronic 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).Should unusual resistance be felt at any time during stent system removal, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.¿ in this case, the deviation of not properly removing the device as instructed per the ifu likely resulted in the reported resistance, as the thumbslide was not retracted and locked prior to withdrawal causing interaction between the exposed tip and patient anatomy resulting in separation of the tip.Additionally, slight force was used during attempts to remove the device and the distal shaft ultimately separated which seemed to be a reasonable clinical response to the reported difficulties.Additional treatment with a snared device was performed to remove the separated portion of the device.The investigation determined that the reported difficulty removing the device and separation appear to be related to user error/operational context.In this case, the deviation of not properly removing the device as instructed per the instruction for use (ifu) likely resulted in the reported resistance, as the thumbslide was not retracted and locked prior to withdrawal causing interaction between the exposed tip and patient anatomy resulting in separation of the tip.Additionally, as resistance was experienced, the physician used slight force during attempts to remove the device and the distal shaft ultimately separated.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
It was reported that the procedure was performed to treat a mildly calcified lesion in the superficial femoral artery (sfa).Following the successful deployment of a 6x150mm supera peripheral self-expanding stent (ses) through a 6fr sheath, the distal end of the delivery catheter was noted to separate after resistance was felt during withdrawal.Slight force was noted to be applied and the separated portion was snared from the vessel.There were no adverse patient sequela nor clinical delay reported.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: 23077620
• Report Number: 2024168-2025-09928
• Device Sequence Number: 18641172
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)270430(10)5051261
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 09/17/2025

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-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 5051261
• 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: 08/26/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6FR 65CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown