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

Model Number	1012631-59
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
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.Based on the information received, the investigation determined that the reported issue appears to be related to operational context as it is likely the device interacted with the moderately calcified and 80% stenosed anatomy during repositioning at the intended lesion causing the reported difficulty advancing and subsequent stent dislodgment.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.The additional device referenced in b5 is filed under separate medwatch report number.
Event or Problem Description
It has been reported the procedure was to treat 80% stenosed lesions in the left external iliac artery and left common iliac artery with moderate calcification.On (b)(6) 2026 the 8x59mm omni elite balloon expanding stent (bes) was advanced to the target lesion and the while repositioning the bes with difficulty, the stent became dislodged from the delivery system balloon.Then, a 7x39mm omni elite bes was implanted; however, post stent implantation an unspecified guide wire (gw) was being advanced to access the patients left side when the gw became entangled with the implanted stent.Therefore, on (b)(6) 2026 cutdown surgery was performed to remove both the stents.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: 24743535
• Report Number: 2024168-2026-01296
• Device Sequence Number: 8903463
• Product Code: NIO
• UDI-Device Identifier: 08717648178528
• UDI-Public: (01)08717648178528(17)290131(10)5082141
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/31/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1012631-59
• Device Catalogue Number: 1012631-59
• Device Lot Number: 5082141
• 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: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown