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

Catalog Number SECX-10-60-135

Device Problem Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/17/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was using a protégé rx carotid stent system with a non-medtronic guidewire, non-medtronic 8f guide catheter and non-medtronic 8f sheath for treatment of a 50mm lesion which had a medium level of calcification in the internal carotid artery and common carotid artery.The lesion exhibited 90% stenosis.The device was prepped as per the ifu without issue.There was no unusual resistance noted when the protective sheath was removed.The lesion was not pre-dilated.There was no resistance encountered when passing the lesion.Upon removal of the ez filter after post-dilation the catheter of the filter got caught by the strand of the protégé stent strut.The physician repeatedly pushed and pulled the filter and also stretched the patient¿s neck and applied pressure to remove the catheter.The filter and catheter were removed from the patient successfully.The physician later took a ct image and noticed that the protégé was deformed inward.Intervention procedure was carried out on (b)(6) to fix the deformation using a balloon.Patient¿s current status is reported as fine with no adverse issue reported.The stent was implanted during this procedure.

Manufacturer Narrative

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: 6659390
• MDR Text Key: 78124938
• Report Number: 2183870-2017-00270
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038680
• UDI-Public: 00821684038680
• 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,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2017
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A178662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Date Device Manufactured: 10/26/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR