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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-8-6-30-135
Device Problems Device Difficult to Setup or Prepare (1487); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the protege rx stent during procedure to treat moderately calcified soft tissue lesion in the proximal left common carotid artery.The vessel had moderate tortuosity and exhibited 75% stenosis.A 7fr sheath was used.There was no damage noted to packaging and no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.It was reported that there were wire movement issues and difficulties loading or exchanging guidewire.Stent dislodgement occurred after removal from patient.Stent dislodged in the patient while removing.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device but no excessive force used.Stent was removed from the patient.Stent struts were exposed on removal.No intervention required for removal.The procedure was completed by subsequently re-crossing the lesion with a separate wire and deploying a carotid stent over it.Second stent was not placed to cage/trap the 1st dislodged stent.Procedure related to technical complication and was inconsequential clinically to patient except for increased procedure time and additional consumable non-medtronic 0.014 wire.No patient injury.
 
Manufacturer Narrative
Product analysis the device was received with the touhy-borst loose the device was returned with the 30mm stent fully deployed, with the device in a deployed state, and with a guidewire stuck in device the guidewire was confirmed as 0.014¿ and with biologics in the device the guidewire could not be removed from the device, most likely because of the biologics present.The device was left in warm water overnight in an attempt to soften the biologics, but this was unsuccessful.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13167276
MDR Text Key289485932
Report Number2183870-2022-00008
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/28/2022
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 Date06/04/2023
Device Catalogue NumberSEPX-8-6-30-135
Device Lot NumberB215948
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2021
Initial Date FDA Received01/05/2022
Supplement Dates Manufacturer Received04/27/2022
Supplement Dates FDA Received04/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2021
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 Age72 YR
Patient SexMale
Patient Weight68 KG
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