MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SECX-8-6-40-135

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a protégé rx with a 6fr sheath and 0.014 guidewire during patient treatment.Ifu was followed.The device was prepped without issue.The lesion was not pre-dilated.The device was passed though a previously deployed stent.No resistance was encountered during advancement of the device.It is reported that stent deformation occurred in vivo during positioning/deployment.The device was replaced with another product to complete the procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the protégé rx was returned.An unknown flushing tool was placed over the catheter shaft.No other ancillary devices were included.The protégé rx was inspected and observed the stent was partially exposed outside the distal rim of the catheter outer.No damage to the stent was observed.The tantalum spheres on the distal end of the stent were observed.Approximately 2 cm of the stent was exposed outside the catheter shaft.Dried blood was observed between the stent struts where the stent was beginning to expand from the distal end of the blue catheter outer.Approximately 2cm of the stent remained loaded the catheter shaft.A non-medtronic ancillary component was loading over the catheter shaft.Dried blood within the catheter lumen was observed proximal to the retainer.A bend to the catheter shaft was noted.Buckling of the blue outer catheter shaft was noted.No damages were noted to the unknown flushing tool.It could not be removed unless the stent was deployed, or the catheter was cut/damaged further.A syringe filled with water was unable to flush to catheter shaft.A 0.014" guidewire was unable to be loaded due to encountered resistance.The protégé rx was placed inside the deployment apparatus and was unable to deploy the stent.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

Additional information: the lesion was pre-dilated.The stent was unable to be deployed.No deformation occurred.Device removed from patient without issue.Second stent placed successfully to complete the procedure.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.

• 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 Key: 8725987
• MDR Text Key: 149132365
• Report Number: 2183870-2019-00343
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038703
• UDI-Public: 00821684038703
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2020
• Device Catalogue Number: SECX-8-6-40-135
• Device Lot Number: A725029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1