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

Model Number	S-60-080-120-P6
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: the unique device identifier (udi) is unknown because the part number and lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6)2022 a supera stent was implanted in the distal popliteal artery to the tibioperoneal trunk.At some point post stent implantation, ultrasound noted an occlusion in the posterior tibial artery.On (b)(6)2023, angiography was performed and noted that the supera stent had migrated.Attempts were made to pass a wire through the migrated stent, but attempts were unsuccessful.It was decided that since there was brisk in-line flow through the anterior tibial artery (ata) and since the patient's wounds were healing, no revascularization intervention in the pta would be performed.No additional information was provided.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was received: it was reported that at the time of deployment, the supera stent was thought to be well apposed to the vessel wall, but since the stent migrated, the cause of the migration may possibly be due to stent under-sizing that was not noted at the time of implantation.Additionally, it is unlikely that the supera stent, which migrated from the site of implantation (distal popliteal to tibioperoneal trunk) to the anterior tibial artery (ata) caused or contributed to the lower limb arterial occlusion as there was brisk arterial flow noted through the ata.The occlusion was noted in the posterior tibial artery (pta) due to progression of disease and restenosis in the area.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 similar incidents from this lot.The reported patient effect of embolism is listed in the supera peripheral stent system instructions for use instructions for use (ifu) as a potential adverse event.It is possible that during initial deployment the diameter of the stent used was inadvertently undersized for the size of the vessel; thus resulting in the reported patient-device incompatibility wall apposition and ultimately resulted in the reported stent migration; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, the reported difficulties possibly contributed to the reported patient effect; however a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appears to be related to the operational context of the procedure.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: 16942521
• Report Number: 2024168-2023-05228
• Device Sequence Number: 17855164
• Product Code: NIP
• UDI-Device Identifier: 08717648211812
• UDI-Public: 08717648211812
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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: 01/31/2024
• Device Model Number: S-60-080-120-P6
• Device Catalogue Number: S-60-080-120-P6
• Device Lot Number: 2020361
• 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: 04/28/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White