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

Catalog Number SEPX-10-7-30-135

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

Visual inspection: the protege rx was removed from the packaging and inspected.The tuohy-borst valve was tight.No external damages to the protege rx were noted.Approximately 0.3cm of the stent was exposed outside of the distal portion of the catheter shaft.Under microscope dried blood was visible at the proximal end of the loaded stent at the retainer.The approximate length the loaded stent was 3cm.Dried blood was observed within the catheter shaft and between struts of the stent.Functional testing: a 0.014¿ guidewire from the lab was front loaded the catheter after the deployment system was flushed with water.The protege rx was loaded the deployment apparatus from within the lab.3.11 lbs of force was applied to the deployment grip, but the stent showed no signs of deployment.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 protege rx stent to treat a slightly calcified, moderately tortuous 70% stenotic lesion in the mid common carotid artery.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.A medtronic device was used as embolic protection.The lesion was not pre-dilated.The device did not pass through a previously deployed stent and no resistance was encountered or excessive force used during delivery of the device to the lesion.The thumbscrew/lock-pin was checked for securement prior to the procedure.It was reported that the stent was unable to deploy.The device was safely removed from the patient.There was no patient injury reported.When the device was returned to the manufacturing facility it was noted that the stent was damaged.

• 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: 9171606
• MDR Text Key: 195975171
• Report Number: 2183870-2019-00491
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051379
• 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: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2020
• Device Catalogue Number: SEPX-10-7-30-135
• Device Lot Number: A742803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Date Device Manufactured: 11/19/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 70