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

Catalog Number SEPX-8-6-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician was attempting to use two protege rx stents along with 5mm spider fx embolic protection during procedure to treat a little calcified plaque lesion in the left proximal common carotid artery with 70% stenosis.The devices were prepped per the ifu with no issues identified.The devices did not pass through a previously deployed stent and no resistance encountered during delivery to lesion.The thumbscrew/lock-pin was checked for securement prior to procedure.The lesion was pre dilated.It was reported that the first stent partially deployed at the lesion.Another protege rx was used but was unable to deploy at the lesion, it was also removed.The physician used another protege rx to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Additional information: both devices were removed from the patient within the delivery system.Intervention was not required.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 for evaluation inside a clear biohazard pouch.No ancillary devices or digital media/physician documentation (cd, flash drive, procedure notes ¿ hard copies) was included.The protégé was removed from the packaging and inspected.The tuohy-borst valve was loosened completely.The distal tip of the catheter showed the distal end of the stent protruding out from the distal tip of the catheter.The distal struts which were exposed showed bending.It is unknown if the stent was attempted to be pulled back into the catheter.No fracturing of the stent was observed.Within the catheter shaft, approximately a 0.2 cm gap was identified between the proximal end of the stent and the retainer.Traces of dried biologics were noted between the retainer and the proximal end of the stent.It was observed the blue outer jacket of the catheter shaft was fractured apart exposing the hypotubing within the catheter.The fracture face of the hypotubing showed twisting and signs of exposure to excessive tensile forces.Buckling of the catheter shaft was observed at the proximal end of 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: 9354150
• MDR Text Key: 189884921
• Report Number: 2183870-2019-00550
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A746473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/22/2019; 02/04/2020
• Supplement Dates FDA Received: 11/27/2019; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1