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

Catalog Number	1012631-29
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2024168-2024-00091
• Device Sequence Number: 15398913
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: 08717648178504
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 1012631-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6F SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male