MAUDE Adverse Event Report: ABBOTT VASCULAR SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	S-60-120-120-P6
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the superficial femoral artery (sfa) with heavy calcification and mild tortuosity.After vessel access, the lesion was pre-treated with balloon angioplasty.The 6.0x120mm supera self expanding stent system (sess) was advanced to the lesion and deployment initiated; however, the stent only partially deployed.The deployment lock was unlocked and the thumb slide was advanced to the most distal position on the handle.The sess, including the partially deployed stent, was removed under fluoroscopy without issue.There was no adverse patient effect and no reported clinically significant delay in the procedure.Another supera stent was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history 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 interaction with the heavily calcified and mild tortuosity anatomy and/or other devices prevented the ratchet from properly engaging and fully releasing the stent from the delivery system; thus resulting in the reported activation/deployment failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 14214278
• Report Number: 2024168-2022-04517
• Device Sequence Number: 11851740
• Product Code: NIP
• UDI-Device Identifier: 08717648211836
• UDI-Public: 08717648211836
• 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): 05/19/2022

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: 08/31/2023
• Device Model Number: S-60-120-120-P6
• Device Catalogue Number: S-60-120-120-P6
• Device Lot Number: 1091061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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: 7FR 43 CM SHEATH
• Patient Sex: Unknown