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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 SEPX-9-30-135
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2019
Event Type  malfunction  
Manufacturer Narrative
The protege rx was returned for evaluation.The lot number indicated on the device labelling was a744582.The protege rx was inspected.The tuohy borst valve was tightened.Approximately 0.5 of the stent was exposed outside of the catheter shaft.No damage to the stent was noted.No damage to the catheter was noted.Approximately 3cm of the stent remained loaded the catheter shaft.A 0.014" lab gw was unable to be loaded due to an obstruction within the lumen.Likely dried residue from the procedure.The protege rx was inserted the deployment apparatus and was able to deploy the stent at 0.40lbs of force.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a protege rx self-expanding stent with a non-medtronic 6fr sheath, 0.018 guide wire and 5fr spider embolic protection in a moderately calcified lesion which exhibited 70% stenosis in the distal common carotid artery.The vessel is reported to be little tortuous with 8mm diameter and lesion length of 20mm.There was no damage noted to packaging.No issues noted when removing device from hoop/tray.The device was prepped per ifu with no issued noted.The vessel was pre-dilated.The thumbscrew/lock-pin was checked prior to procedure.The lock-pin was removed when device was inserted in patient.There was no resistance felt when advancing the device and no excessive force used.It was reported that during procedure, physician was unable to deploy stent (deployment issue).The procedure was completed using another protege rx stent.There was 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 
091708734
MDR Report Key9361142
MDR Text Key195099504
Report Number2183870-2019-00551
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
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 11/22/2019
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 Date11/25/2020
Device Catalogue NumberSEPX-9-30-135
Device Lot NumberA744582
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2019
Initial Date FDA Received11/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age60 YR
Patient Weight50
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