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

Model Number SECX-10-60-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to manufacturing facility for analysis.The distal portion of the stent was protruding out from the distal end of the catheter outer sheath approximately 2mm.There was damage to tip noted.Evidence of biologic was seen within the catheter and on y-manifold.The device was flushed and a 0.014" guide wire loaded.Maximum peak force required to deploy stent in deployment apparatus to be less that 3lbs and device was unable to deploy.The inner shaft (proximal grip) exhibited a bend at 3.53lbs.There was no damage noted to the inner distal assembly.There was no damage to the stent condition.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to treat the mid carotid artery using protege stent.The sheath was so hard that the protege which was delivered but could not be deployed.A new product with the same size was used without issues and the procedure was completed without any issues.There was no patient injury 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 ; IE ; 091708734
• MDR Report Key: 9680510
• MDR Text Key: 195418665
• Report Number: 2183870-2020-00041
• 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
• Report Date: 02/07/2020

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: 05/08/2020
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A642696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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