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

Model Number S-60-040-120-P6

Device Problems Device Damaged by Another Device (2915); Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/13/2022

Event Type  Injury  

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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the sheath was inserted interaction with the previously deployed supera stent resulted in the reported device damaged by another device and thus resulting in the reported migration.The treatment appears to be related to the operational context of the procedure as a non- abbott stent was used to embed the migrated supera stent in place.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2022, the supera self expanding stent was implanted in the common femoral artery.On (b)(6) 2022 an angiography was performed and the sheath that was inserted interacted with the supera stent, causing it to migrate upward and now, no portion of the supera remains in the target lesion.A non- abbott stent was used to embed the supera in place so it will not migrate again.No additional information was provided.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: 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: 15146867
• MDR Text Key: 297053863
• Report Number: 2024168-2022-08444
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: 08717648211799
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: S-60-040-120-P6
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 2031861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention