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

Model Number	1012631-29
Medical Device Problem Codes	Device Damaged by Another Device (2915); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
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.A conclusive cause for the reported difficulties could not be determined.Device damaged by another device may be attributed to several factors including, but are not limited to, lesion inadequately predilated, lesion selection (not treating the distal lesion first), interaction between accessory devices or previously implanted stents.Factors that may contribute to stent migration include, but are not limited to, patient anatomical morphology, patient disease state, non-uniform or partial stent apposition or under-sizing of the vessel.There was no damage noted to the stent delivery system (sds) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is possible the stent may have migrated due to the manipulation of accessory devices during the procedure; causing the reported stent migration and device damaged by another device; however, based on the information provided and without the device to examine, this cannot be confirmed.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 de novo, moderately calcified, mildly tortuous left common iliac artery (cia) lesion.An 8x29 mm omnilink elite stent was implanted.During the catheter exchanges for post dilatation, wire position was lost and the post dilatation balloon was not able to advance from the radial approach.The decision was made to post dilate via an up and over approach from the right common femoral artery.During the manipulation of catheters and wires the omnilink stent moved distally in the cia.The stent was post-dilated and the procedure was completed.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: 25257817
• Report Number: 2024168-2026-02117
• Device Sequence Number: 12117439
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: (01)08717648178504(17)270930(10)4041941
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/22/2026

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: 1012631-29
• Device Catalogue Number: 1012631-29
• Device Lot Number: 4041941
• 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: 05/04/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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
• Patient Sex: Unknown