MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; STENT CAROTID

Model Number SECX-8-6-40-135

Device Problems Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2014

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.(b)(4).

Event Description

The physician was intending to use a protégé rx for treatment of the left internal carotid artery.During the procedure it was reported that the physician was unable to track the device out of the shuttle sheath.The stent was withdrawn and the procedure was successfully completed with a competitor stent.There was no patient injury or intervention was reported.Evaluation summary: protégé rx was received with the deployment paddle distant to the tuohy borst valve approximately 90mm, tuohy borst valve loose, sanguine material was noted on the y-manifold, the outer sheath was pulled back from the distal tip, the stent was exposed, and approximately 1.5 stent cells were flowered.A 10cc water filled syringe was attached to the y-manifold and the annual spaces were flushed: clear fluid observed exiting the distal end of the outer sheath.A 0.14in guidewire was loaded through the distal tip with ease.The guidewire loaded protegerx was loaded into a deployment apparatus and deployed within the specification of less than 3lbs.The tapered stent was examined: no abnormality or deformity was noted.The distal assembly was examined: no abnormalities or deformities were noted in the retainer, marker band, or distal tip.

• Brand Name: PROTEGE RX
• 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: mary haufek ; 4600 nathan lane north; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 5147172
• MDR Text Key: 28592321
• Report Number: 2183870-2015-00383
• Device Sequence Number: 1
• Product Code: NIM
• 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
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2016
• Device Model Number: SECX-8-6-40-135
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: 9868782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• 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