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

Model Number SECX-10-60-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2020

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 protege rx with a 9fr25 cm non-medtronic sheath and a 7fr200cm guardwire for treatment.Embolic protection was used.No damage was noted to the device packaging.No difficulties were experienced when removing the device from hoop/tray.The device was prepped per the ifu with no issues noted.The lesion was pre-dilated with a non-medtronic device.There was no resistance encountered when advancing the device.The device was not passed through a pre-deployed stent.It was reported that upon deployment attempt at the lesion, the inner sheath got stuck to the outer sheath and the stent was partially deployed.The device was removed from the patient.There was no patient injury reported for this event.

Manufacturer Narrative

Additional information: the patient's condition is stable.Image review: two photographic images were received into medtronic investigation lab for evaluation.The images are of the protégé rx.The first image is of the proximal end of the protégé rx stent delivery system.The y-manifold has been advanced proximally towards the proximal deployment paddle.A stopcock valve has been threaded onto the y-manifold annual spaces port.The second image is of the distal end of the protégé rx stent delivery system.The outer sleeve of the stent delivery system has been advanced proximally exposing approximately 3.5 rows of stent cells.The stent cell row structures do not exhibit any stretching damage or stent cell structural tearing.Two images of double ended arrows were received.Additional copies of the protégé rx stent delivery system images were received.Technical analysis of the images provided indicate that an attempt to deploy the stent was made, y-manifold moved proximally towards the deployment paddle.It is not known how much of the stent was exposed within the patient.It is noted that the stent do es not exhibit the damage usually associated with a partially deployed stent removed being pulled through a support sheath.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 device was safely removed from the patient.It is unknown if vessel damage occurred.Another protégé rx was successfully implanted.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: 9806072
• MDR Text Key: 195390228
• Report Number: 2183870-2020-00074
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038680
• UDI-Public: 00821684038680
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: SECX-10-60-135
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A724326
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1