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

Catalog Number SECX-10-7-40-135

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use two protégé rx devices and a spider fx device during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid left common carotid artery.Severe calcification and tortuosity are reported.Ifu was followed and the devices were prepped without issue.It is reported that resistance was encountered when advancing both protégé rx devices and excessive force was required during delivery.It is reported that the stent wire snapped and the stent could not be deployed.The procedure was completed using a competitor stent.No patient injury.

Manufacturer Narrative

Additional information: the device was removed through the sheath without any intervention required.Evaluation summary: the protégé rx device was returned.No ancillary devices were included.The protégé rx was inspected and the distal end of the stent was found to be flowered out from the distal rim of the blue outer.The tuohy-borst valve was tightened.The distal tip and guidewire lumen were exposed outside from the distal tip of the catheter about 0.5cm.A bend to the catheter was observed at approximately 81 cm and 134 cm from the distal tip.Buckling of the blue outer was noted at approximately 0.8cm and 2cm distal the gray strain relief.No damage to the stent was observed.A guidewire from the lab was attempted to be loaded; however the occluded lumen did not allow it to pass.The protégé rx was inserted into the lab deployment apparatus.After loosening the tuohy-borst valve the stent was attempted to be deployed but the catheter shifted due to the bend while pushing the deployment grip.The stent was deployed manually against resistance.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: 8094132
• MDR Text Key: 128042467
• Report Number: 2183870-2018-00517
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2019
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A551663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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