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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-8-6-40-135
Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2021
Event Type  malfunction  
Manufacturer Narrative
Product analysis: the device returned coiled in a biohazard pouch.Device was decontaminated with cidex opa solution soak and tergazyme soak.The device was returned with the distal portion of the shaft missing.It appears that the detachment happened at the rx port.No functional testing could be carried out due to the condition of the returned device.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use protege rx self-expanding stent along with an 8fr non-medtronic sheath, 0.014" spider guidewire and spider 5mm embolic protection during procedure to treat a non calcified plaque lesion in the left proximal common carotid artery with 100% stenosis in the internal carotid artery interlayer.The vessel was none tortuous.The vessel diameter and lesion length are 6-8mm and 30mm respectively.There was no damage noted to packaging.There was no issue noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.Deployment issue occurred with physician unable to deploy stent.The was no resistance encountered during delivery to lesion.The device did not pass through a previously deployed stent.The thumb switch/lock-pin was checked for securement prior to procedure.The lock-pin was removed before deployment.Physician replaced with a stent of the same model of medtronic and deployed smoothly.There was no patient injury.The device was returned with the distal portion of the shaft missing.
 
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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 
EI  
091708734
MDR Report Key12428227
MDR Text Key273167980
Report Number2183870-2021-00320
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 09/06/2021
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 Date12/23/2022
Device Catalogue NumberSEPX-8-6-40-135
Device Lot NumberB137916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/26/2021
Initial Date FDA Received09/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2020
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 Age47 YR
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