MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number 1012631-29

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the right common iliac artery.During advancement of the 8.0x29mm omni elite peripheral stent system using a 6f sheath, resistance was felt with the anatomy and the stent became dislodged in the distal tibial artery.The stent remained on the guide wire and a small balloon was used to deploy the omni elite stent in the tibial artery in healthy tissue.Another omni elite stent was used to successfully complete the procedure.There was no adverse patient sequela and no significant delay in procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported difficulties in addition to subsequent foreign body in patient and unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the right common iliac artery.During advancement of the 8.0x29mm omni elite peripheral stent system using a 6f sheath, resistance was felt with the anatomy and the stent became dislodged in the distal tibial artery.The stent remained on the guide wire and a small balloon was used to deploy the omni elite stent in the tibial artery in healthy tissue.Another omni elite stent was used to successfully complete the procedure.There was no adverse patient sequela and no significant delay in procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18438821
• MDR Text Key: 331834381
• Report Number: 2024168-2024-00091
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: 08717648178504
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• 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,Followup
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1012631-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 6F SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male