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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
Model Number SECX-10-60-135
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation.The distal portion of the stent was protruding out from the distal end of the catheter outer sheath approximately 2mm.A serpentine coiling of the outer assembly was noted 124 ¿ 128 cm from the distal tip.Maximum peak force was required to deploy stent in the deployment apparatus.The inner shaft (proximal grip) exhibited a bend at 2.26 lbs.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use a protege rx carotid stent during treatment of a lesion in the patient¿s mid common carotid artery.There was no calcification.Vessel tortuosity is reported.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed.The device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Pre-dilation was performed.The device was not passed through a previously deployed stent.No resistance was encountered during advancement of the device.It is reported that the stent was unable to be deployed.The device safely removed from the patient and was replaced with a non-medtronic carotid device.No patient injury reported.
 
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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 
IE  
091708734
MDR Report Key9648190
MDR Text Key194837181
Report Number2183870-2020-00031
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00821684038680
UDI-Public00821684038680
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 01/30/2020
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 Date10/15/2020
Device Model NumberSECX-10-60-135
Device Catalogue NumberSECX-10-60-135
Device Lot NumberA724326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/21/2020
Initial Date FDA Received01/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2018
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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