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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-10-7-40-135
Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician intended to use a protege rx stent to treat a plaque calcified, moderately tortuous, 40% stenotic lesion in the proximal common carotid artery.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.No embolic protection was used.The device did pass through a previously deployed stent and resistance was encountered but no excessive force used during delivery of the device to the lesion.It was reported that the stent was not released normally and was deformed in vivo.A new stent was used to complete the procedure.There was no patient injury reported.
 
Manufacturer Narrative
Additional information: pre-dilation was performed with a 6 pta catheter.The previously deployed stent was non-medtronic.Resistance experienced was reported as severe.The deformation reported is referring to the unable to deploy event.Upon removal of the device from the patient, the stent was unable to be opened.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.
 
Manufacturer Narrative
Product analysis: the protégé rx was returned.A tapered stent was included placed inside an individual pouch.No ancillary devices or digital media/physician documentation was included.The protégé rx was removed from the packaging and inspected.The tuohy-borst valve was loose and the stent was not loaded.Approximately 1cm of the inner guidewire tubing was exposed outside from the distal rim of the catheter.With directly lighting applied to the distal end of the catheter, no damages to the distal rim of the catheter or signs of biologics within the catheter lumen were identified.The tapered stent was removed from the pouch and inspected.The stent length was approximately 4cm, which aligns with the stent length as indicted on the product labeling.The deployment system was tested by hand.No signs of resistance were noted during simulated deployment actions.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
MDR Report Key8531300
MDR Text Key142482660
Report Number2183870-2019-00180
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/09/2020
Device Catalogue NumberSEPX-10-7-40-135
Device Lot NumberA752407
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2019
Date Manufacturer Received06/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age70 YR
Patient Weight70
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