MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number 1012625-39

Device Problems Difficult To Position (1467); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.Possible factors that may contribute to difficult to position through an introducer sheath may include, but are not limited to: damage to the stent, damaged to the device, damage to the introducer sheath.In this case, it is possible that the outer diameter of the introducer sheath may have been too large that during advancement the introducer sheath encountered resistance and/or became entrapped with the previously implanted stent resulting in the reported stretched stent implant; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficult to position.The reported material deformation and additional therapy non-surgical treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a moderately calcified lesion in the right common iliac artery.A 9x39mm omni elite stent was deployed in the right common iliac artery; however, a sheath was being advanced through the stent to obtain left access and the sheath became stuck with the stent.The stent migrated and elongated towards the left common iliac artery and aorta bifurcation.The procedure was successfully completed by using two unknown kissing stents to smash the omnilink elite 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 PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7308279
• MDR Text Key: 101341728
• Report Number: 2024168-2018-01502
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/01/2018

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 Expiration Date: 02/28/2021
• Device Catalogue Number: 1012625-39
• Device Lot Number: 7090441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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