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

Model Number 1012625-39

Device Problem Migration (4003)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot and relabeled.The investigation was unable to determine a conclusive cause for the reported stent migration.The reported patient effect of embolism is listed in instructions for use (ifu) as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to the design, manufacture.

Event Description

It was reported the procedure was performed on (b)(6) 2018, to treat a lesion in the right common iliac artery.The 9.0x39mm omnilink elite stent was implanted without issue.On (b)(6) 2020, a second procedure was performed to treat an aortic aneurysm.It was noted the omnilink elite was not where it had been deployed.The stent was noted in the aortic aneurysm.Another stent was implanted, crushing the omnilink stent against the vessel wall.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: OMNILINK ELITE
• 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: 10644373
• MDR Text Key: 210364385
• Report Number: 2024168-2020-08353
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179341
• UDI-Public: 08717648179341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 1012625-39
• Device Catalogue Number: 1012625-39
• Device Lot Number: 8062041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 77