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

Model Number	S-60-150-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
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 de novo heavily calcified, right superior femoral artery that is 99% stenosed.When attempting to deploy the 6.0x150mm supera peripheral stent system, the stent deployed within the guiding catheter.The stent was crimped with a balloon and pulled into the sheath along with the guiding catheter.A new supera peripheral stent system was used to complete the procedure.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report it was stated that the balloon was removed from the anatomy after pre-dilatation and then re-advanced in order to crimp the stent to the guiding catheter to be removed from the anatomy.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 similar 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 stent deployment the guiding catheter was too close and the stent inadvertently deployed into the guiding catheter resulting in the reported activation failure.The treatment appears to be related to the operational context of the procedure as reportedly the balloon was removed from the anatomy after pre-dilatation and then re-advanced in order to crimp the stent to the guiding catheter to be removed from the anatomy.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.

• 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: 21296637
• Report Number: 2024168-2025-01222
• Device Sequence Number: 9245013
• Product Code: NIP
• UDI-Device Identifier: 08717648211843
• UDI-Public: (01)08717648211843(17)250630(10)3072461
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: S-60-150-120-P6
• Device Catalogue Number: S-60-150-120-P6
• Device Lot Number: 3072461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown