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

Catalog Number	SECX-10-60-135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/06/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7973383
• Report Number: 2183870-2018-00469
• Device Sequence Number: 1774360
• Product Code: NIM
• UDI-Device Identifier: 00821684038680
• UDI-Public: 00821684038680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention