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

Catalog Number SECX-10-60-135

Device Problem Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2016

Event Type  Injury  

Event Description

The physician was using a protege rx carotid stent.During the procedure, the physician placed a 6f guiding catheter at the external carotid artery and deployed the protege stent at the carotid artery.Upon removing the 6f guiding catheter, the stent got deformed inward and seemed to be a heart shape.For that reason, a 7mm diameter balloon was used to post dilated.Another stent carotid stent (10mm - 24) was deployed inside the protege and the issue was solved.The procedure was completed without further issue.

Event Description

The target lesion was the right ica.The patient has very rare vasculature; va run from the distal of ica on both sides.Stenosis was 50%, almost no calcification, small tortuosity.Lesion length: 30 to 40mm (narrowed area is about 10mm but plaque exists on both distal and proximal of the narrowed area.) vessel diameter: distal 5.8mm, narrowed area 2.7mm, proximal 7.9mm since the patient had special vasculature a carotid guardwire was used in the ica and filterwire ez on va.The balloon and stent used during the intervention were delivered by following the guardwire.In addition, in order to avoid the filterwire getting stuck after stent deployment, 6f catheter was delivered to the proximal of filterwire after deploying the filterwire, then the intervention was proceeded.The protege stent was deployed, post-dilated, and embolic protection devices were removed from the patient, all the operations were done without any issue.In the end, 6fr catheter was removed, and deployment condition of the stent was checked.Then the distal portion of the stent was found deformed inward.Post dilation was carried out but the deformation was not solved.Additional stent wallstent was placed to maintain the sufficient vessel diameter.2 months have passed since the intervention, and the patient's current condition is fine.Dapt is still on going.F/u will be performed as according to the rules at the facility.

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: 5811660
• MDR Text Key: 50076094
• Report Number: 2183870-2016-00542
• Device Sequence Number: 1
• Product Code: NIM
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SECX-10-60-135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• 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