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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-8-6-40-135
Device Problems Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 05/15/2023
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
A physician was attempting to implant a protege rx for the treatment of a 40mm calcified fibrous lesion in the distal region of the common carotid artery.The artery was 6-8mm in diameter and was severely tortuous and moderately calcified.A 6fr non medtronic sheath was used.A 7mm spider was used for embolic protection.The protege rx was prepped as per the ifu with no issues identified.It was reported the stent  became dislodged and was noted to be partially deployed at the end of the non medtronic sheath.A 6mm pta balloon was inserted and pinned the stent against the sheath/ pulled down to the groin and the pta balloon lost grasp and the stent was noted to be partially in common femoral art in left groin and partially in the subcutaneous.The physician was able to see part of the stent at the incision site and opened the puncture site with hemostats and pulled the stent out of the body.The device had not passed through a previously deployed stent.There was no resistance encountered while advancing the device.The physician restarted the procedure and used a non medtronic stent with a 7mm spider fx.
 
Manufacturer Narrative
Additional information: the delivery system was safely removed, and no vessel damage was noted.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.
 
Manufacturer Narrative
Product analysis the device was returned with the touhy-borst tight.The device was returned with a bend in the push rod the stent was returned out of the device, a white substance was adhered to the stent and it was confirmed as 40mm the device was returned with blue outer sheath pushed up on distal tip the device was returned with, a kink on blue outer approx.16.5cm from distal tip the device was returned with, a bend on blue outer approx.5cm from strain relief image analysis the customer returned one movie clip for evaluation.Clip: the movie clip is a short clip of an angiogram.This is zoomed in and without all landmarks, though appears to be a partially deployed stent in the common carotid artery.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.
 
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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 Key16963490
MDR Text Key315576284
Report Number2183870-2023-00173
Device Sequence Number1
Product Code NIM
UDI-Device Identifier00821684038703
UDI-Public00821684038703
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 NumberB517977
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/15/2023
Initial Date FDA Received05/19/2023
Supplement Dates Manufacturer Received05/25/2023
07/26/2023
Supplement Dates FDA Received06/15/2023
07/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2023
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) Required Intervention;
Patient Age85 YR
Patient SexFemale
Patient Weight82 KG
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