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

Catalog Number SECX-8-6-40-135

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the physician was attempting to use a protege rx stent to treat a moderately calcified lesion in the common carotid artery.The ifu was followed and the device was prepped without issue.It was reported that the lock pin was removed before attempting to deploy the stent.The lesion was reported to have been pre-dilated and the device was passed through a previously deployed stent.It was reported that stent deformation occurred in vivo during deployment.The physician reported the stent did not deploy.The distal tip was reported to have been almost bent.The procedure was completed using a new stent.No patient injury was reported.

Manufacturer Narrative

Evaluation summary: the catheter was returned for evaluation.Inspection of the catheter revealed a puncture in the bonding section of the distal outer shaft and proximal shaft.Sanguine residue was observed within the hypotube of the y-connector.When the syringe was pressurized sanguine tinted fluid and residue were observed exiting the distal end of the outer sheath of the sds.As the stent was attempting to deploy, the deployment paddle exhibited a bend during the process.The returned catheter stent would not deploy within the maximum peak force of 1.76 lbs.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: 8027364
• MDR Text Key: 125760300
• Report Number: 2183870-2018-00484
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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: 10/06/2019
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A535251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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