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

Model Number	1012632-59
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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.The reported patient effects of occlusion is a known observed and potential patient effects as listed in the omnilink elite electronic instructions for use.Based on the information received, the investigation determined that the reported issue and treatment appears to be related to operational context.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.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.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the mildly tortuous, heavily calcified common iliac artery.When advancing the 10x59mm omnilink elite stent delivery system resistance was felt with anatomy and the stent dislodged.An unspecified balloon dilatation catheter was advanced and inflated in the attempt to bring back the stent; however, was unsuccessful.Therefore, the stent was held in place with device and another 9.0x59mm omilink elite stent was attempted to be advanced to treat the lesion; however, met resistance with anatomy and dislodged.The dislodged stent was attempted to be snared but the snare device became stuck with anatomy and the stent.It was noted that the stents had occluded in the proximal external iliac artery blocking most of the blood flow through the iliac.The snare device could not be pulled back.The snare device was broken on purpose and the stuck portion along with both stents were crushed into the vessel wall with a non-abbott stent over them.Blood flow was restored when the stents were crushed and clinically significant delay was noted.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20774565
• Report Number: 2024168-2024-13934
• Device Sequence Number: 4399520
• Product Code: NIO
• UDI-Device Identifier: 08717648178566
• UDI-Public: (01)08717648178566(17)250731(10)2020141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 11/25/2024

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: 07/31/2025
• Device Model Number: 1012632-59
• Device Catalogue Number: 1012632-59
• Device Lot Number: 2020141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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: 10X59MM OMNILINK ELITE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male