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

Catalog Number SECX-10-7-40-135

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2016

Event Type  malfunction  

Event Description

The physician was attempting to use a protege rx carotid self-expanding stent to treat a lesion in the ica.The device was inspected prior to use with no issues noted.No resistance noted during delivery of the device.During deployment of the stent in the ica, the delivery pusher shaft was fractured.Md retrieved the stent and used another product to complete procedure.No clinical sequelae reported.

Manufacturer Narrative

Evaluation summary : the protégé rx was received with approximately 2cm of the stent exposed/deployed.Outer was separated approximately 132cm from the distal tip.Due to the separated outer the stent could not be deployed.No damage was noted to the distal tip.Direct light was applied to the distal end of the catheter and red biological material was discovered within the outer lumen.(b)(4).

• 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: 5727481
• MDR Text Key: 47491906
• Report Number: 2183870-2016-00398
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2017
• Device Catalogue Number: SECX-10-7-40-135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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