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

Catalog Number SECX-10-7-40-135

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

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 intended to use a protégé rx with a 6f guardwire temporary occlusion and aspiration system for treatment of a lesion in the patient¿s carotid artery.The ifu was followed and the device was prepped without issue.Pre-dilation was carried out.It was reported that when the physician began delivering the protégé stent, post delivery of the temporary occlusion and aspiration system the distal tip of the stent delivery system(sds) got caught on the gold marker of the guardwire.The stent failed to be delivered to the target location.The stent was removed without any issue and a non-mdt device was used to complete the procedure without further issue.No patient injury was reported.

• 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: 7581478
• MDR Text Key: 110453538
• Report Number: 2183870-2018-00321
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2019
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A476863
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Date Device Manufactured: 06/16/2017
• 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