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

Model Number	S-55-040-120-P6
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a greater than 70% stenosed vessel in the proximal superficial femoral artery (sfa).The vessel diameter was roughly 5-6mm in diameter and was prepared using a balloon at nominal pressures.Atherectomy was not used.The collagen plug was deployed for a non-abbott closure device and was causing blockage.The 5.5x40mm supera self expanding stent system (sess) was attempted to be deployed to treat the blockage; however, after a third to halfway of the stent was deployed the physician decided he didn't like how the non-abbott closure device was deforming the supera stent and decided it was not suitable after taking additional pictures.The physician removed the partially deployed supera stent under fluoroscopy with no issues and replaced with a covered stent that completed the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation determined the reported difficulties were likely due to circumstances of the procedure.Based on the information provided, the non-abbott closure device was interacting with the supera stent causing the stent to deform.Reportedly, it was decided that the supera stent was not suitable after taking additional pictures.The physician removed the partially deployed supera stent under fluoroscopy with no issues and replaced with a covered stent that completed the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9/h3 device return status.

• 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: 13196380
• Report Number: 2024168-2022-00266
• Device Sequence Number: 6045760
• Product Code: NIP
• UDI-Device Identifier: 08717648226069
• UDI-Public: 08717648226069
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 01/31/2022

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: 04/30/2023
• Device Model Number: S-55-040-120-P6
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 1050561
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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: 7 FR SHEATH; ANGIO-SEAL
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 74 KG