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

Catalog Number 11013-39

Device Problem Difficult to Advance (2920)

Patient Problem Perforation of Vessels (2135)

Event Date 11/09/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the subclavian artery with 50% stenosis, mild calcification and no tortuosity.The emboshield nav 6 embolic protection system (eps) filter was successfully deployed midway down the left internal mammary artery (lima) via radial approach with an omnilink elite stent placed across the subclavian stenosis via common femoral artery (cfa) access.Upon retrieval, the retrieval catheter could not pass into the ostium to meet the filter as the stent was blocking it.The physician made several attempts to balloon dilate the ostium to pass the catheter, but it couldn¿t avoid the omnilink stent to track into the lima.He also ballooned the implanted omnilink stent to try and drag it backwards to free up the lima access but unsuccessful.The filter was stranded.It was then decided to simply pull the filter back up the lima without the retrieval catheter by pulling back on the barewire.The filter moved without difficulty, and met with the retrieval catheter at the subclavian-lima junction where it collapsed and was withdrawn easily.However, the lima ruptured during angiogram check and a cardiologist and vascular surgical support managed to control the bleeding by using a covered stent bailout to re-line the lima after an hour or so.The physician was not sure what caused the rupture although the repeated ballooning to try to create a path past the omnilink was far from ideal.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device 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.The additional vascular device referenced is being filed under a separate medwatch report number.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents.The reported patient effect of perforation is listed in the omnilink elite instruction for use (ifu) as a known potential patient effect associated with the use of a stent in peripheral arteries and / or biliary tree.Based on the reported ¿when we tried to pass the retrieval catheter from the arm down the subclavian and into the lima, it wouldn¿t pass into the ostium to meet the filter as the stent was blocking it.-several attempts to balloon dilate the ostium to pass the catheter, but it wouldn¿t avoid the omnilink tines¿, it is likely the omnilink stent position was not ideal at the ostium exposing the tines inhibiting the advancement of the recovery sheath of the nav 6.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: correction lot# from unknown to 2040442.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: 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: 15888296
• MDR Text Key: 304553650
• Report Number: 2024168-2022-12042
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 11013-39
• Device Lot Number: 2040442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 12/02/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMBOSHIELD EMBOLIC PROTECTION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male