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

Catalog Number 1012632-19

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/14/2024

Event Type  Injury  

Event Description

It was reported the procedure was to treat a stenosed lesion in the brachiocephalic artery.After the lesion was pre-dilated with a non-abbott balloon catheter, the 9.0x19mm omnilink elite stent delivery system (sds) was inflated to 11 atmospheres (atm) for 10 seconds.When the sds was attempted to be removed, the stent migrated proximal to the target lesion.A non-abbott balloon catheter was used to over dilate the migrated stent to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

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 incidents from this lot.It was reported the procedure was to treat a stenosed lesion in the brachiocephalic artery.It should be noted that the omnilink elite instructions for use (ifu) states: the omnilink elite stent system is indicated for the treatment of atherosclerotic iliac artery lesions.It is unknown the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported stent migration.The reported treatment and foreign body in patient appear to be related to operational context 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
• 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: 18806185
• MDR Text Key: 336512373
• Report Number: 2024168-2024-02559
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1012632-19
• Device Lot Number: 2070741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: TERUMO'S RADIFORCUS 0.035INCH 260CM; TOKAI MEDICAL PRODUCTS' OPTIMO 8F 90CM
• Patient Outcome(s): Required Intervention