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

Catalog Number	S-50-060-120-P6
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a mildly calcified lesion in the right popliteal artery.The 5.0x60mm supera self expanding stent system (ses) was advanced to the target lesion and deployment started however the guide wire moved proximal.The ses was retracted after it was thought the stent had fully deployed however the stent retracted too and ended up in the superficial femoral artery (sfa).Although not intended, the physician was happy with the placement of the stent in the sfa.Another supera stent was placed in the target lesion to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) 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.It is possible after stent deployment during the delivery system removal the device tip inadvertently got caught on the deployed stent thus resulting in the stent to inadvertently retract with the device resulting in the reported stent migration; however this cannot be confirmed.The investigation determined a conclusive cause for the migration difficulties cannot be determined.As reported, although not intended, the physician was happy with the placement of the stent in the sfa.Another supera stent was placed in the target lesion to complete the procedure.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 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: 19567017
• Report Number: 2024168-2024-07367
• Device Sequence Number: 15029078
• Product Code: NIP
• UDI-Device Identifier: 08717648211744
• UDI-Public: (01)08717648211744(17)240731(10)2082061
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: 07/31/2024
• Device Catalogue Number: S-50-060-120-P6
• Device Lot Number: 2082061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2022
• 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: Other
• Patient Sex: Unknown