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

Catalog Number	SECX-8-6-40-135
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
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 was attempting to use a protege rx stent to treat a moderately calcified lesion in the common carotid artery.The ifu was followed and the device was prepped without issue.It was reported that the lock pin was removed before attempting to deploy the stent.The lesion was reported to have been pre-dilated and the device was passed through a previously deployed stent.It was reported that stent deformation occurred in vivo during deployment.The physician reported the stent did not deploy.The distal tip was reported to have been almost bent.The procedure was completed using a new stent.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the catheter was returned for evaluation.Inspection of the catheter revealed a puncture in the bonding section of the distal outer shaft and proximal shaft.Sanguine residue was observed within the hypotube of the y-connector.When the syringe was pressurized sanguine tinted fluid and residue were observed exiting the distal end of the outer sheath of the sds.As the stent was attempting to deploy, the deployment paddle exhibited a bend during the process.The returned catheter stent would not deploy within the maximum peak force of 1.76 lbs.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: 8027364
• Report Number: 2183870-2018-00484
• Device Sequence Number: 11121494
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• 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): 01/17/2019

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: 10/06/2019
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A535251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1