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

Model Number	1012630-19
Medical Device Problem Codes	Difficult to Remove (1528); Device Damaged by Another Device (2915); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was a procedure performed to treat a target lesion in the moderately calcified right common carotid artery ostium.A non-abbott embolic protection device filter and wire were placed at the target site and pre-dilatation was performed.The omnilink stent was advanced and deployed without issue.Post dilatation was performed and the non-abbott filter retrieval catheter was advanced.Resistance was noted advancing the retrieval catheter and the catheter caught on the edge of the omnilink stent.The filter wire advanced into the stent and the physician tried manipulating the retrieval catheter to remove it; however, the filter popped into the stent and the filter wire snapped.The filter remained caught in the omnilink stent and was unable to be retrieved.The stent was noted to be damaged, as a result of the interaction with the retrieval catheter, and moved a small amount into the aorta.The patient was sent for a surgical procedure to remove the non-abbott filter.The decision was made to leave the omnilink stent in place, as there was concern of causing more damage.A surgical bypass procedure was performed, from the aorta to the common carotid artery, above the stent.Post procedure, the patient is in stable condition.No additional information was provided.
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 surgical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 15070854
• Report Number: 2024168-2022-07983
• Device Sequence Number: 14825064
• Product Code: NIO
• UDI-Device Identifier: 08717648178450
• UDI-Public: 08717648178450
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 11/30/2024
• Device Model Number: 1012630-19
• Device Catalogue Number: 1012630-19
• Device Lot Number: 1061041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: SPIDER EMBOLIC PROTECTION DEVICE AND WIRE
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 62 KG