MAUDE Adverse Event Report: ABBOTT VASCULAR INC. OMNILINK ELITE; STENT, ILIAC

Model Number	1012622-29
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.It was reported the procedure was to treat a lesion in the left vertebral artery.It should be noted that the omnilink elite instructions for use (ifu) states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of = 5.0 mm and = 11.0 mm, and lesion lengths up to 50 mm.It is unknown if the ifu deviation directly caused or contributed to the reported event.Based on the information provided, a definitive cause for the reported issue could not be determined; however, the reported treatment appears to be related to operational context of the procedure.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code: 1494 - incorrect anatomy.
Event or Problem Description
It was reported the procedure was to treat a lesion in the left vertebral artery.The 6.0x29mm otw omnilink elite stent delivery system (sds) was advanced to the target lesion; however during the first inflation to 11 atmospheres, the balloon lost pressure and could not be re-inflated.A non-abbott balloon catheter was used to post dilate and ensure the stent was apposed to the vessel wall.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22307669
• Report Number: 2024168-2025-06396
• Device Sequence Number: 8705563
• Product Code: NIO
• UDI-Device Identifier: 08717648179198
• UDI-Public: (01)08717648179198(17)270630(10)4011941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012622-29
• Device Catalogue Number: 1012622-29
• Device Lot Number: 4011941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown