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

Model Number	S-60-150-120-P6
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis which identified the stent was exposed and struts were broken.The reported difficult to advance 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.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 during advancement interaction with the introducer sheath resulted in the reported difficult to advance.Manipulation of the device and/or inadvertent mishandling during shipment for analysis resulted in the noted exposed and broken stent 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.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately calcified lesion in the superficial femoral artery (sfa).A 6x150mm supera peripheral self-expanding stent (ses) was attempted to be advanced into the anatomy over a.018" non-abbott guidewire; however, the ses could not be advanced passed the 6f introducer sheath.The ses was removed and replaced with another stent that was used to complete the procedure.There were no adverse patient effects nor clinical delay.Subsequent to the initially reported information, the device was received and the analysis revealed that the stent implant was exposed 4 millimeters (mm) from the distal end of the sheath.The struts at the distal end of the stent implant were broken.Follow-up was performed with the site; however, the site was not aware of the reported damages found in the returned device analysis.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: 21396400
• Report Number: 2024168-2025-01792
• Device Sequence Number: 9245134
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)260131(10)4022061
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 4022061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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: GUIDEWIRE: .018", BSC V18; SHEATH: 6F, COOK
• Patient Sex: Unknown