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

Catalog Number SECX-C-10-7-40-135

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2019

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 7x10x40 stent in the common carotid artery.It was reported that the stent was unable to be deployed.The device was removed from the patient and another protege 7x10x40 stent was prepared.There were no issues noted when removing the device from the tray and the device was prepped without issue.Resistance was encountered during delivery of the device to the lesion.The second stent could not be deployed and the catheter snapped while trying to deploy the stent.A non-medtronic device was successfully used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Additional information: it was reported that the patient had a tortuous aorta.It has been confirmed that only the unable to deploy event with resistance en countered occurred while the device was inside the patient.The stent is reported as being unable to move on the delivery catheter as if stuck.The device was removed from the patient.Upon removal from the patient, the physician attempted to deploy the stent and snapped the catheter.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

Device evaluation: visual inspection: the protégé was removed from the packaging and inspected.The tuohy-borst valve was loose and the stent remained loaded.The deployment grip was positioned pushed forward.The exposed hypotube was curved at an approximate 45-degree angle where it introduced to the tuohy-borst valve.At the proximal area of the catheter shaft where the hypotube extended past the strain relief it was observed the hypotube showed two concurrent bends/curves of approximately 45-degrees.At the distal edge of the hypotubing segment, the blue outer shaft was fractured apart.Approximately 6.5cm of the push wire was exposed between the fractured segments.The fracture/separation face of the catheter jacket suggested exposure excessive tensile forces.The stent remained loaded and measured approximately 4cm which is consistent with the product labeling associated to lot a731593.Dried blood was noted within the catheter between the stent struts between the tantalum spheres.Dried biologics was observed within the catheter shaft.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: 8599364
• MDR Text Key: 144689994
• Report Number: 2183870-2019-00253
• Device Sequence Number: 1
• Product Code: NIM
• 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: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Catalogue Number: SECX-C-10-7-40-135
• Device Lot Number: A731593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1