MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE PERIPHERAL STENT SYSTEM; PERIPHERAL STENT DELIVERY SYSTEM

Model Number	1012622-39
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure performed was to treat a lesion in distal common iliac artery.The omnilink elite stent delivery system (sds) was advanced to the target lesion without issue and the stent was deployed and was fully apposed.The physician then passed a sheath through the implanted stent to do a completion run and the stent migrated into the distal aorta.The physician attempted to snare the dislodged stent from the aorta, but was unsuccessful.A balloon catheter was able to capture the stent and stented it in a non-abbott covered stent.The contralateral side dissected later in the procedure and the patient underwent femorofemoral (femoral-femoral) bypass surgery; however, it was reported that this was unrelated to the omnilink stent.No additional information was provided.
Additional Manufacturer Narrative
The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The investigation determined the reported difficulties and subsequent treatments including surgical intervention and foreign body in patient appear to be related to circumstances of the procedure, as it is likely that the physician passed a sheath through the implanted stent to do a completion run, causing the reported stent migration into the distal aorta.The physician attempted to snare the dislodged stent from the aorta but was unsuccessful.A balloon catheter was able to capture the stent and stented it in a non-abbott covered stent.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of occlusion, embolism and surgical intervention are listed in the omnilink elite vascular balloon-expandable stent system, electronic instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the initial report filing, additional information received confirmed the occlusion of the iliac which resulted in surgery was a result of the failure to not adequately retrieve the stent that had been pushed up into the distal aorta.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 14053171
• Report Number: 2024168-2022-03751
• Device Sequence Number: 4987263
• Product Code: NIO
• UDI-Device Identifier: 08717648179204
• UDI-Public: 08717648179204
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 05/31/2024
• Device Model Number: 1012622-39
• Device Catalogue Number: 1012622-39
• Device Lot Number: 0120341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown