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

Model Number	1012626-19
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 the procedure was to treat a calcified lesion in the right common iliac artery.The lesion was pre-dilated with a 9.0x20mm armada balloon catheter.The 10.0x19mm otw omnilink elite stent delivery system (sds) was advanced over a command 18 st guide wire to the target lesion and the balloon inflated to 12 atmospheres.Post inflation the stent was not visible on fluoro therefore the sds was removed.The stent was noted to be dislodged proximally on the shaft of the sds.A new stent of the same size was used to complete the procedure.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 analysis was performed on the returned device.The reported stent dislodgement was confirmed.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, a definitive cause for the reported stent dislodgement could not be determined.It was reported that the omnilink elite stent delivery system (sds) was advanced to the target lesion; however, the stent was not visible on fluoroscopy, and therefore the sds was removed.The stent was noted to be dislodged proximally on the shaft of the sds.Factors that may contribute to stent dislodgement include, but are not limited to, improper or inadequate crimping during manufacture, an incorrectly sized sheath, forceful sheath removal, inadvertent mishandling during preparation, interaction with accessory devices, or manipulation against resistance.In this case, analysis of the returned device confirmed the reported stent dislodgement.It is possible that the patient¿s calcified lesion contributed to the reported stent dislodgement and the observed stent deformation (flared struts).There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21344161
• Report Number: 2024168-2025-01453
• Device Sequence Number: 13001730
• Product Code: NIO
• UDI-Device Identifier: 08717648179365
• UDI-Public: (01)08717648179365(17)260131(10)2081841
• 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,Followup
• Report Date (Section B): 02/17/2025

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: 01/31/2026
• Device Model Number: 1012626-19
• Device Catalogue Number: 1012626-19
• Device Lot Number: 2081841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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: 7X30 COOK SHEATH.; COMMAND 18 ST WIRE.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White