MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SECX-10-7-40-135

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Event Description

Physician used a protégé rx carotid stent system with a 6f sheath and non-medtronic embolic protection device for treatment of a 30mm severely calcified, moderately tortuous lesion the right distal- common carotid artery of diameter 8mm.Lesion exhibited 85% stenosis.Device prepped as per ifu without issue.Lesion was pre-dilated using a 5mm non-medtronic pre-dilation device.It was reported that the device did not pass through a previously deployed stent and there was no resistance encountered while advancing the device.It was reported that post-deployment, the stent tip broke off when pulling the delivery catheter back through the ¿touey¿.The component embolized within the delivery catheter.¿touey¿ and the sheath were removed thereby removing the tip component from the patient.Stent was deployed successfully so the case was completed.No patient injury reported.

Manufacturer Narrative

The protégé rx device was returned.Within the box the device was returned with ancillary device: y-connector which was not part of the protégé rx delivery system.Three images were returned for evaluation.Per the images, the protégé rx was positioned at the target lesion and the stent was deployed successfully at the targeted lesion.The tuohy borst was observed loose and was able to be tightened.Visual inspection of the delivery catheter revealed the tip broke approximately 20mm proximally to marker band of the inner lumen.The stent was not returned as it was successfully implanted.The overall length of the catheter was measured at approximately 139cm.The measure working length of the catheter is outside of product specification of 135cm.This is an indication that the catheter was stretched during withdrawal.A known good protégé rx device with distal tip was compared to the defective returned protégé rx which revealed the tip was broken.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6796270
• MDR Text Key: 82775116
• Report Number: 2183870-2017-00346
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060001
• 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,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2019
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A471511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2017
• 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 Age: 63 YR