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

Model Number	S-50-040-120-P6
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified lesion in the superficial femoral artery (sfa).After the vessel was prepared using a 5.0mm unknown balloon catheter to 8atms for 2mins, a 5x40mm supera peripheral self-expanding stent (ses) was advanced to the lesion through a 6fr sheath and successfully deployed with the proximal end of the stent 10-15cm away from the sheath.However, upon the removal of the device, not under fluoroscopy, it was noted that the stent and catheter tip remained inside the introducer sheath.There were no adverse patient effect nor clinically significant delay in procedure.Subsequent to the initially reported information, the device was received and the returned device analysis revealed that the tip, tip lumen, and tip jacket were separated at the distal end of the ratchet stem, and the distal end of the stent implant was stretched and had broken struts.The account confirmed to be aware of the found damages and noted that they occurred during physician handling post-procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.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 delivery system was not removed under fluoroscopy.It should be noted that the supera peripheral stent system instructions for use, states: under fluoroscopy, remove the device from the guide wire and evaluate the improved luminal quality of the treated area.It is undetermined if the deviation of the instructions for use caused/contributed to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that after successful stent deployment during removal the tip of the device inadvertently got caught on the deployed stent resulting in the tip of the device and stent becoming entrapped within the sheath; thus, resulting in the reported activation failure.Post-procedure manipulation of the compromised device resulted in the noted device damages (separated tip/tip lumen/tip jacket, stent stretched/broken struts).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- incorrect removal.

• 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: 22084445
• Report Number: 2024168-2025-05357
• Device Sequence Number: 6935423
• Product Code: NIP
• UDI-Device Identifier: 08717648211737
• UDI-Public: (01)08717648211737(17)261130(10)4120561
• Combination Product (Y/N): N
• 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): 05/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: S-50-040-120-P6
• Device Catalogue Number: S-50-040-120-P6
• Device Lot Number: 4120561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic