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

Model Number	1012625-39
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Embolism (1829); Foreign Body In Patient (2687)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10644373
• Report Number: 2024168-2020-08353
• Device Sequence Number: 16753767
• Product Code: NIO
• UDI-Device Identifier: 08717648179341
• UDI-Public: 08717648179341
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: 11/30/2021
• Device Model Number: 1012625-39
• Device Catalogue Number: 1012625-39
• Device Lot Number: 8062041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 77