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

Model Number 1012631-39

Device Problems Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a moderately calcified lesion in the left iliac artery.The kissing stent technique was attempted.A non-abbott catheter was advanced first.The 8.0x39mm omnilink elite stent delivery system (sds) was advanced however when pushing up past the target lesion, resistance was met with the calcified lesion and the sds came off the guide wire and went up into the aorta, then double backed down and tied itself into a knot.The sds could not be moved at this point; therefore a cut down was performed where the physician was able to untie the sds shaft.The procedure was continued with the same device and the omnilink stent was able to be deployed in the target lesion.There was a clinically significant delay due to the cut down.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the return device.The reported difficult to advance and entrapment could not be confirmed due to the condition of the returned unit and the difficulties were based on anatomical conditions.The proximal balloon being tied in a knot was confirmed.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 complaints reported from this lot.Based on the information provided, the reported difficulties appear to be due to procedural circumstances.It is likely that the resistance encountered during advancement was due to interaction with the calcified lesion.Additionally, the reported entrapment of the device and damage to the balloons likely occurred during the attempt to advance against resistance causing the balloon to double back down and tie itself into a knot.The additional surgical intervention and delay in treatment were due to circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 11373827
• MDR Text Key: 233339975
• Report Number: 2024168-2021-01441
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178511
• UDI-Public: 08717648178511
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

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 Expiration Date: 05/31/2022
• Device Model Number: 1012631-39
• Device Catalogue Number: 1012631-39
• Device Lot Number: 8120541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention