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

Model Number 1012632-19

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Visual analysis was performed on the returned omnilink elite.The difficulty advancing was unable to be confirmed due to the condition of the returned unit.The reported stent damage was confirmed.Additionally, it was noted that the stent implant was dislodged from the balloon.The distal end of the stent implant was located on the distal end of the proximal balloon marker.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 complaints reported from this lot.The investigation determined the reported difficulties and noted dislodged stent were due to circumstances of the procedure.It is likely that the resistance encountered during advancement was due to interaction with the challenging anatomy.Additionally, it is likely that advancing against resistance and interaction with the challenging anatomy caused the stent damage, including the noted dislodged stent.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous, 75% stenosed lesion in the left common iliac artery.A 9x19mm omni elite vascular balloon expandable stent (bes) was advanced to the target lesion with resistance from the anatomy.Deployment was initiated at the target lesion; however, one of the stent struts was noted as mangled and deployment was aborted.The delivery system and partially deployed stent was removed as one unit without issue, and another omni elite bes was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.The returned device analysis found that the stent was dislodged from the balloon.

• 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: 13177094
• MDR Text Key: 283767880
• Report Number: 2024168-2022-00162
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178535
• UDI-Public: 08717648178535
• 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
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012632-19
• Device Catalogue Number: 1012632-19
• Device Lot Number: 1030841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 94 KG