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

Model Number	1012631-19
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2024
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 this was a procedure to treat the left external iliac artery and the right external iliac artery.A 7.0x60mm absolute pro vascular self-expanding stent was implanted first without issue in the left external iliac artery.Then an 8.0mm/19mm/otw omni elite balloon expandable stent system (bess) was advanced to be advanced to the right external iliac artery.However, the physician did not like the angle of the vessel and decided to retract and readvance the bess through the external iliac artery.The bess was advanced through the absolute pro implanted distal stent.Resistance met with the anatomy when positioning the bess in the artery and the physician applied force to turn the bess.A decision was made to remove the bess due to the resistance.The bess was removed without difficulty.However, the stent was discovered missing.Angiography was performed and the stent was found stuck in the middle portion of the implanted absolute pro stent.A 014 non-abbott guidewire and an unspecified balloon catheter were advanced to deploy the detached stent.The stent was deployed inside the previously implanted stent.No damaged noted on the absolute pro stent.Another otw omni elite vasc 8.0mm/19mm/135cm stent was deployed to treat the right external iliac artery.The patient was scheduled to stay overnight for observation unrelated to the stent procedure.The patient is stable.There was no clinically significant delay in 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 preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling.In this case, the reported difficulties and treatment appear to be related to operational context of the procedure as it is likely the difficult/delayed positioning (retraction/readvancement of the device) is due to interaction with the patients anatomy.During removal it is likely the device interacted with the previously implanted stent causing the reported stent dislodgement as the dislodged stent was found stuck with the previously implanted stent.The dislodged stent was deployed inside the previously implanted stent using a balloon catheter.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported issue and treatment appears to be related to circumstances of the procedure.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: 20338521
• Report Number: 2024168-2024-11520
• Device Sequence Number: 15459961
• Product Code: NIO
• UDI-Device Identifier: 08717648178498
• UDI-Public: (01)08717648178498(17)260131(10)2082241
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/06/2024

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 Expiration Date: 01/31/2026
• Device Model Number: 1012631-19
• Device Catalogue Number: 1012631-19
• Device Lot Number: 2082241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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: 7.0X60MM ABSOLUTE PRO VASCULAR STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG