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

Model Number	1012630-59
Medical Device Problem Codes	Failure to Advance (2524); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat an unknown lesion.The 7.0x59mm otw omnilink elite stent delivery system (sds) was advanced however failed to cross the lesion and expand.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.Based on the limited information provided and without the return of the device, a definitive cause for the reported failure to advance and activation failure of the stent could not be determined.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that may contribute to an activation failure include, but are not limited to, inflation technique, contrast concentration, loose connection with the indeflator, anatomical conditions, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.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.

• 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: 24712628
• Report Number: 2024168-2026-01264
• Device Sequence Number: 14893837
• Product Code: NIO
• UDI-Device Identifier: 08717648178481
• UDI-Public: (01)08717648178481(17)290228(10)5091941
• 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
• 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): 03/27/2026

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: 1012630-59
• Device Catalogue Number: 1012630-59
• Device Lot Number: 5091941
• 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: 03/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• 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