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

Model Number 1012632-19

Device Problems Difficult or Delayed Activation (2577); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/24/2020

Event Type  Injury  

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 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edge of the stent and the stent migrated into healthy tissue in the external iliac artery.The delivery system was withdrawn to the migrated stent and the stent was implanted in healthy tissue and fully apposed to the vessel wall.A second omnilink stent was implanted without issue in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
• 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: 10417705
• MDR Text Key: 203306497
• Report Number: 2024168-2020-06826
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178535
• UDI-Public: 08717648178535
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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: 73 YR
• Patient Weight: 75