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

Catalog Number SEPX-8-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2020

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 protégé rx self-expanding stent with a spider fx embolic protection device during treatment of a 30mm plaque lesion in the patient¿s proximal left common carotid artery of reported diameter 7mm.Slight vessel tortuosity and moderate calcification are reported.Ifu was followed.Lesion exhibited 75% stenosis.No damage noted to the packaging prior to use.No issues noted when removing the device from the packaging.The device was prepped without issue.Pre-dilation was performed using a 4mm balloon.The device was not passed through a previously deployed stent.No resistance was encountered during advancement.It is the stent reached the target lesion, but deployment was unsuccessful.It was reported that stent struts were partially exposed within the vessel during deployment attempt.Following removal from the patient it could also not be deployed.The device was safely removed from the patient.No patent injury reported.

Manufacturer Narrative

Product analysis: the device was removed from the packaging and visually inspected.The device was received with the stent fully enclosed within the outer sheath of the catheter.No damage to the distal tip was noted.No anomalies or damages were found on the dark blue outer sheath.Dried blood was observed within the catheter shaft.The device strain relief indicated that the stent diameter and length were 8 x 40 mm, consistent with the reported device.The protégé rx was unable to be flushed due to encountered resistance while attempting to advance the plunger of the loaded syringe filled with water.A 0.014¿ guidewire was unable to be loaded through the device distal tip and navigated out the device guidewire exit port.The device was placed into a deployment apparatus with the tuohy-borst valve loose and would not deploy when a maximum peak force of 2.96 lbs was applied.A bend was noted on the deployment paddle when the stent was attempting to deploy.An attempt was made to manually deploy the stent, but resistance was encountered, and the stent was unable to deploy.The blue outer sheath was cut, and the stent was removed.Visual inspection of the stent revealed no abnormalities.No abnormalities noted to the inner distal assembly and retainer.Fdc - 25: stent unemployed 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: 10238307
• MDR Text Key: 199829360
• Report Number: 2183870-2020-00208
• 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
• Report Date: 08/27/2020

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: 02/28/2021
• Device Catalogue Number: SEPX-8-40-135
• Device Lot Number: A791664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 07/05/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR