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

Catalog Number 42045100-120

Device Problem Migration (4003)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat an 80% stenosed de novo lesion in the superficial femoral artery (sfa) with mild calcification and mild tortuosity.The 4.5x100mm supera self expanding stent system (sess) was advanced to the target lesion and the stent was implanted; however, it was noted the the supera stent was moving up and down in the artery with the patient's leg movement.Therefore, an 7x100mm absolute pro stent was implanted to jail the supera stent.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.It is possible that non-uniformal stent apposition due to the anatomy resulted in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported stent migration cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: partial udi provided as the lot number is unknown.

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.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4 - lot # - correction - lot number updated.

• 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: 18991114
• MDR Text Key: 338791473
• Report Number: 2024168-2024-03780
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648224898
• UDI-Public: (01)08717648224898(17)250228(10)3031661
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42045100-120
• Device Lot Number: 3031661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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