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

Model Number	S-70-060-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
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.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 withdrawal of the delivery system the tip of the device inadvertently got caught with the deployed stent resulting in the stent being inadvertently pulled back into the sheath; thus resulting in the reported activation/deployment failure.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 to treat a mildly calcified, mildly tortuous superficial femoral artery that is 90% stenosed.Using a 6f guiding sheath from the contralateral side along with a 7.0x60mm supera self-expanding stent the stent was deployed.Post dilatation was attempted; however, it was noted that the stent was not in its deployed position and was noted to be in guiding sheath.It was noted when removing the supera delivery system the stent was pulled back inadvertently into the sheath.The guiding sheath along with the stent were removed.A new same size supera stent was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.

• 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: 20612987
• Report Number: 2024168-2024-12938
• Device Sequence Number: 8792940
• Product Code: NIP
• UDI-Device Identifier: 08717648344268
• UDI-Public: (01)08717648344268(17)250630(10)3071361
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/05/2024

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: 06/30/2025
• Device Model Number: S-70-060-120-P6
• Device Catalogue Number: S-70-060-120-P6
• Device Lot Number: 3071361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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: DESTINATION 6F 45CM
• Patient Sex: Unknown