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

Model Number	1012632-29
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure performed was to treat the left subclavian artery.Resistance was noted when removing the stylet/protective sheath of the 9.0x29mm omni elite vascular balloon-expandable stent (bes), force was applied and the bes dislodged when the yellow protective sheath was being removed, prior to entering the body.It was noted that one side of the stent appeared frayed.A new omnilink stent was used to complete the procedure.There was no device use or patient involvement, and no clinically significant delay in the 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.H6: medical device problem code 2017 - excessive force.
Additional Manufacturer Narrative
The device was returned for analysis.The reported device dislodged or dislocated was confirmed.The reported difficult to remove could not be tested due to the device condition.The reported improper or incorrect procedure or method could not be tested as it is based on operational context.The reported stent break could not be confirmed; however, stent deformation was observed.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 that force was applied when removing of the stylet/protective sheath on the balloon-expandable stent system (bes).It should be noted that the omnilink elite instructions for use (ifu) states: applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and stent delivery system components.It is unknown if the ifu deviation( directly caused or contributed to the reported event.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported difficulties could not be determined.It is possible that inadvertent mishandling during sheath or stylet removal or during device preparation, may have contributed to the reported stent dislodgement and observed stent damage; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 24223520
• Report Number: 2024168-2026-00433
• Device Sequence Number: 9366004
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: (01)08717648178542(17)280229(10)4091641
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 4091641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG