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

Model Number	1012633-29
Medical Device Problem Codes	Difficult to Insert (1316); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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.H6: medical device problem code 2017 - distal to stent.
Event or Problem Description
It was reported the procedure was to treat a lesion in the left common iliac artery.A 9.0x29mm omnilink elite stent was placed without issue.A 10.0x29mm otw omnilink elite stent delivery system (sds) was advanced however it felt like the stent was getting hung up on the previously placed stent therefore the sds was removed.An attempt was made to advance the sds again however resistance was met with the 7fr sheath and it was noted the distal end of the stent struts were mangled.A new 9mm omnilink elite 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.Return device analysis of the 10.0x29mm omnilink elite noted the stent was stationary on the balloon however was not located within the markers.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported stent damage was confirmed.The reported failure to advance and difficult to insert was not tested due to the condition of the retuned device.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.It was reported that the omnilink elite could not cross the previously implanted stent.It should be noted that the omnilink elite instructions for use (ifu), states: ¿when treating multiple lesions, the distal lesion should be initially stented, followed by stenting of the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent and reduces the chances for dislodging the proximal stent.¿ in this case, it is unknown the ifu deviation contributed to the reported event.In this case, based on the reported information and evaluation of the returned device, the reported failure to advance appears to be due to interaction with the previously implanted stent while trying to advance distal to the stent.It is likely that after the failed attempt to cross the previously implanted stent, damage to the stent struts occurred causing resistance during the attempt to readvance the stent delivery system (sds) through the sheath.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21066186
• Report Number: 2024168-2025-00084
• Device Sequence Number: 3418153
• Product Code: NIO
• UDI-Device Identifier: 08717648178580
• UDI-Public: (01)08717648178580(17)261031(10)3051241
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2025

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 Model Number: 1012633-29
• Device Catalogue Number: 1012633-29
• Device Lot Number: 3051241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White