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

Model Number	1012631-19
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	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified and tortuous lesion in the iliac artery.After the lesion was pre-dilated using an unknown balloon catheter, an 8x19mm ominilink elite balloon-expandable stent (bes) was attempted to be advanced to the lesion; however, resistance was felt and the bes was noted to become dislodged.Therefore, the dislodged stent was snared and the procedure was completed using balloon dilatation only.There were no adverse patient sequela nor clinical delay.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.
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 reported information, it is likely that the difficulty advancing was due to interaction with the anatomy which was described as heavily calcified and tortuous.Additionally, it is likely that during the attempt to advance against resistance, the stent become compromised on the balloon resulting in dislodgment.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: b1 - adverse event/product problem: adverse event removed.H1 - type of reportable event: serious injury removed; malfunction added.H6 - health effect - impact code 4641 removed; 2199 added.
Event or Problem Description
Subsequent to filing the initial mdr, the following information was received which clarified how the dislodged stent was removed from the patient anatomy: the balloon expandable stent was removed along with the delivery catheter as a single unit instead of the initial report that the dislodged stent was snared.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: 21606163
• Report Number: 2024168-2025-02658
• Device Sequence Number: 13080328
• Product Code: NIO
• UDI-Device Identifier: 08717648178498
• UDI-Public: (01)08717648178498(17)270228(10)3091241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012631-19
• Device Catalogue Number: 1012631-19
• Device Lot Number: 3091241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• 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