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

Catalog Number SECX-10-60-135

Device Problem Material Deformation (2976)

Patient Problem Death (1802)

Event Date 09/06/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the physician used a protégé rx with a non-medtronic guidewire and non-medtronic 9f guide catheter to treat a tortuous 40mm calcified lesion with 90% stenosis in the carotid artery.The device was inspected prior to use with no difficulties noticed.It was reported the lesion was pre-dilated with a non-medtronic device.A 10x60mm protégé rx was advanced and deployed without encountering any resistance.The stent delivery system was removed from the patient with no difficulty noticed.It was confirmed by (b)(4) that the stent was elliptical in shape.Several additional post dilations were carried out to improve blood flow.The procedure was finished at this point.The balloon was also observed to be in an elliptical state once removed from the patient following post-dilation.The physician reports that there was no calcification as the balloon inflated without issue.One (1) week post procedure, the patient was treated for ic occlusion.Two (2) non-medtronic devices were placed inside the protege stent.An mri was carried out indicated the patient¿s outcome was not good and condition was deteriorating.The patient was due to present for a follow-up procedure, however, the patient passed away a few days post the second procedure.

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: 7973383
• MDR Text Key: 123952555
• Report Number: 2183870-2018-00469
• 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,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2019
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A525047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/17/2018
• Supplement Dates Manufacturer Received: 11/06/2018
• Supplement Dates FDA Received: 12/04/2018
• Date Device Manufactured: 09/17/2017
• 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
• Patient Outcome(s): Death; Required Intervention