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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN PROTEGE RX; CAROTID STENT

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COVIDIEN PROTEGE RX; CAROTID STENT Back to Search Results
Model Number SECX-8-6-40-135
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2015
Event Type  Injury  
Event Description
This procedure was performed in (b)(6).The physician was attempting to treat a lesion of 80% stenosis and excessive calcification in a moderately tortuous right ica with a carotid guardwire temporary occlusion embolic protection device.Pre-dilation was carried out at the lesion once at 6atm.There was no anomalous resistance during removal of protective device.No abnormalities were noted during device inspection and preparation before the operation.No resistance was felt when the device was passed through the lesion site.During the operation for cas, the physician considered carrying out distal filter but he confirmed that occipital artery was communicated with the vertebral artery, at the external carotid artery side so it was decided that the guardwire would be used at the external carotid.When the physician attempted to remove the device using an open cell protégé rx stent, after carotid artery stenting (cas) was performed, the guardwire became stuck on the cell and there was a difficulty in removal.The balloon of the guardwire was also ruptured and torn.Then, he stopped using the device.The physician used a new guardwire as replacement to continue the operation.The balloon part adhered to the stent at the external carotid and the carotid stent (cas) procedure was completed.There was no adverse event to the patient, however, the detached piece of the guardwire balloon remains stuck on the protégé.
 
Manufacturer Narrative
A review of the manufacture records for this device could not be conducted because the lot number was not known.
 
Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.
 
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Brand Name
PROTEGE RX
Type of Device
CAROTID STENT
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
stephanie riley
4600 nathan lane n
plymouth, MN 55442
7633987000
MDR Report Key4765636
MDR Text Key5953697
Report Number2183870-2015-00180
Device Sequence Number1
Product Code NIM
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 Health Professional,User Facility,Company Representative,company representati
Reporter Occupation Health Professional
Type of Report Initial
Report Date 04/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSECX-8-6-40-135
Device Catalogue NumberSECX-8-6-40-135
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Outcome(s) Other;
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