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U.S. Department of Health and Human Services

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

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COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID Back to Search Results
Catalog Number SECX-8-6-40-135
Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event 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.
 
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.
 
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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 Key8027364
MDR Text Key125760300
Report Number2183870-2018-00484
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00821684038703
UDI-Public00821684038703
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 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
Device Operator Health Professional
Device Expiration Date10/06/2019
Device Catalogue NumberSECX-8-6-40-135
Device Lot NumberA535251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/02/2018
Initial Date FDA Received11/01/2018
Supplement Dates Manufacturer Received01/07/2019
Supplement Dates FDA Received01/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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