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

Catalog Number	SECX-10-7-40-135
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the protégé rx stent delivery system affiliated to this investigation was returned.The stent was not found/received with the device.Upon visual examination, it was noted that the distal tip was deployed, sheath retracted, on the device upon receiving.It was observed that the tuohy-borst valve was still tight and in place upon examination.Approximately 4.20cm of the sheath had been retracted, exposing the distal tip.An unknown residue was observed inside the device sheath under back lighting.
Event or Problem Description
A protégé rx carotid stent system was used on an unknown vessel.Device ifu was followed.It was reported the catheter was positioned at the procedure site and the stent was exposed before unlocking.As stent was not completely exposed, it was removed from the body and the procedure was completed using a new device.No patient injury reported.
Additional Manufacturer Narrative
Additional information : the stent was not found/received with the device.The stent was confirmed to have been discarded by the hospital.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: 6806236
• Report Number: 2183870-2017-00354
• Device Sequence Number: 19167221
• Product Code: NIM
• UDI-Device Identifier: 00821684038727
• UDI-Public: 00821684038727
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/29/2017

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: 12/06/2018
• Device Catalogue Number: SECX-10-7-40-135
• Device Lot Number: A385484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 08/19/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1