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

Model Number	1012632-29
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	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure performed was to treat a moderately calcified, common iliac artery.Resistance was noted when advancing the 9.0x29mm omnilink elite vascular balloon-expandable stent (bes) system through a 6f sheath, the stent dislodged but remained in the sheath and was simply withdrawn with the sheath.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.Device dislodged or dislocated was confirmed.The reported difficult to advance could not be tested due to the device condition.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 and the observations from the returned analysis, the investigation determined that the reported issue appears to be related to circumstances of the procedure.It was reported that the balloon-expandable stent (bes) met resistance when advancing through a 6f sheath, and the stent dislodged.Analysis of the returned device confirmed the stent dislodgement.In this case, it is likely that the device interacted with the introducer sheath during advancement causing the reported difficulty to advance and subsequent stent dislodgement.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 performed was to treat a moderately calcified, common iliac artery.Resistance was noted when advancing the 9.0x29mm omnilink elite vascular balloon-expandable stent (bes) system through a 6f sheath, the stent dislodged but remained in the sheath and was simply withdrawn.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.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: 21284235
• Report Number: 2024168-2025-01115
• Device Sequence Number: 7892297
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: (01)08717648178542(17)260731(10)3020141
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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 Expiration Date: 07/31/2026
• Device Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 3020141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 77 KG