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

Model Number	1012624-29
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
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 was to a lesion in the left common iliac artery.During advancement of the 8x29mm omnilink balloon expanding stent bes, when the bes had just passed the 6f sheath the stent became dislodged from the delivery system.The delivery system was removed without issue; however, a 4mm balloon was used to implant the stent in healthy tissue in the external iliac artery.There was no adverse patient sequela.A non-abbott stent was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other complaints.A conclusive cause for the reported stent dislodgement could not be determined; however, the subsequent unexpected medical intervention and device embedded in tissue or plaque appears to be related to circumstances of the procedure.Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, anatomical conditions, handling of the stent during preparation, and interaction with accessory devices.In this case, it is possible that interaction with accessory devices and/or the challenging anatomy during advancement, may have contributed to the reported stent dislodgement in the left common iliac artery; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D1 correction: brand name updated.D2a correction: common device name updated.D3 correction: name, address updated.

• 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: 19559342
• Report Number: 2024168-2024-07338
• Device Sequence Number: 12445023
• Product Code: NIO
• UDI-Device Identifier: 08717648179297
• UDI-Public: (01)08717648179297(17)270131(10)3082141
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 07/12/2024

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: 1012624-29
• Device Catalogue Number: 1012624-29
• Device Lot Number: 3082141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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: 6F TERUMO SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 64 KG