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

Catalog Number SEPX-8-6-40-135

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was using protege rx self-expanding stent along with 6fr sheath,.014 guide wire and 6mm embolic protection to treat a moderately calcified plaque lesion in the mid common carotid artery with 70% stenosis.The vessel diameter and lesion length is 7-5mm and 35mm respectively.Vessel is moderately tortuous.There was no damage noted to packaging and any issues noted when removing the device from hoop/tray.The device was prepped per ifu.The lesion was not pre dilated.The device did not pass through a previously deployed stent with no resistance encountered when advancing the device.It was reported that physician tried to deploy the stent exactly across lesion but while deploying, stent jumped from its location into the internal common artery.There was sufficient distal landing zone when stent deployed in unintended lesion site.Another stent was used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Additional information: the delivery catheter did not catch on stent upon withdrawal if information is provided in the future, a supplemental report will be issued.

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: 9145254
• MDR Text Key: 165205786
• Report Number: 2183870-2019-00477
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A771714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2019
• Date Device Manufactured: 01/24/2019
• 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: 65 YR
• Patient Weight: 67