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

Catalog Number SEPX-8-6-40-135

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Activation, Positioning or Separation Problem (2906)

Patient Problems Stroke/CVA (1770); Thrombosis (2100)

Event Date 12/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician used a protégé rx with a 5mm spider fx embolic protection device during treatment of a plaque lesion in the patient¿s common carotid artery.Slight vessel tortuosity reported.Lesion exhibited 75% stenosis.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed, device prepped without issue.Pre-dilation was not performed.Resistance was encountered when advancing the device.No excessive force was used.Deployment issues were noted.Lock-pin was removed at time of attempted deployment.It is reported that stent began to deploy at target location, but stent migrated from the common carotid artery bifurcation to the internal carotid artery leading to vessel spasm and stroke.Sub-acute stent thrombosis is reported.The patient was given vasodilator drugs.A non-medtronic stent was placed to keep the vessel open.No further injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: no stent movement/removal attempts will be made.Patient is reported to be well.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 9538189
• MDR Text Key: 173725970
• Report Number: 2183870-2020-00003
• 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,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2021
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A884503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR