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

Catalog Number	SECX-10-7-40-135
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
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 intended to use a protégé rx with a 6f guardwire temporary occlusion and aspiration system for treatment of a lesion in the patient¿s carotid artery.The ifu was followed and the device was prepped without issue.Pre-dilation was carried out.It was reported that when the physician began delivering the protégé stent, post delivery of the temporary occlusion and aspiration system the distal tip of the stent delivery system(sds) got caught on the gold marker of the guardwire.The stent failed to be delivered to the target location.The stent was removed without any issue and a non-mdt device was used to complete the procedure without further issue.No patient injury was reported.

• 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: 7581478
• Report Number: 2183870-2018-00321
• Device Sequence Number: 11259676
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• 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
• Report Date (Section B): 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2019
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A476863
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1