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

Catalog Number SEPX-10-7-40-135

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation visual inspection: the protégé rx was received with the outer sheath pull back exposing the distal end of the stent.Approximately 1.5cm of the stent was exposed and flowered (pre-deployed).The dark blue outer sheath is twisted and buckled at the distal tip of the printed strain relief.The printed stain relief was removed, it was observed the dark blue outer sheath had separated from its bond to the manifold exposing the ss hypotube.The dark blue outer sheath also exhibits necking down and torsional twist onto the push wire.The light blue outer sheath shows evidence of twisting and buckling over the distal inner assembly.The tuohy-borst valve was tightened.Functional testing: due to the extent of the damage to the device, the stent could not be deployed out of the catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician was attempting to use a protégé rx device to treat a 28mm moderately calcified lesion with 80% stenosis in the left proximal common carotid artery.There was little tortuosity reported, artery diameter 6mm.An 8fr cook sheath, 0.014 abbott guidewire and a 6mm spiderfx embolic protection was used in the procedure.There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped per ifu with no issues.The device did not pass through a previously deployed stent.No resistance was encountered and excessive force was not used.It was reported that the stent could not be deployed upon repeated attempts.After the stent reached the lesion site, the stent was positioned and the y valve was released.When the stent was ready to be released, it was found that the stent could not be released.After many efforts, the stent failed.The patient returned to the ward safely.No symptoms or complications with this event and no patient injury reported.When the stent was returned t o the manufacturing facility, it was noted that the stent was pre-deployed.

• 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: 8887155
• MDR Text Key: 163158756
• Report Number: 2183870-2019-00401
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/13/2020
• Device Catalogue Number: SEPX-10-7-40-135
• Device Lot Number: A612783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2018
• 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: 82 YR