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

Model Number	1012632-19
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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 reported from this lot.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the anatomical conditions prevented the stent from fully deploying.Manipulation of the device likely caused the stent to migrate.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 to treat a target lesion in the common iliac artery.When deploying the 9.0mmx19mmx135cm omnilink stent in the target lesion, there was lack of distal deployment on the distal edge of the stent and the stent migrated into healthy tissue in the external iliac artery.The delivery system was withdrawn to the migrated stent and the stent was implanted in healthy tissue and fully apposed to the vessel wall.A second omnilink stent was implanted without issue in the target lesion.No additional treatment was performed.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10417705
• Report Number: 2024168-2020-06826
• Device Sequence Number: 2452591
• Product Code: NIO
• UDI-Device Identifier: 08717648178535
• UDI-Public: 08717648178535
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

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: 09/30/2022
• Device Model Number: 1012632-19
• Device Catalogue Number: 1012632-19
• Device Lot Number: 9040441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/17/2020
• 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: 73 YR
• Patient Weight: 75