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

Catalog Number SEPX-8-6-40-135

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/04/2024

Event Type  Injury  

Event Description

A physician was attempting to implant a protege rx for treatment of a calcified plaque lesion in the mid common carotid artery.A spider fx was used for embolic protection.The device was prepped as per the ifu with no issues identified.The lesion was not pre-dilated.The device passed though a previously deployed stent and resistance was also met while advancing the device.It was reported releasing it was found that the stent was broken at the proximal marker area. the fragments of the broken stent were partially blocked by the spider protection device and pulled out of the body, but some fragments were still in the body and were stuck at the distal end of the stent and could not be retrieved.On the (b)(6) 2024 three-dimensional image reconstruction of the patient's carotid artery was performed.It was found that the remaining stent fragments were hanging on the distal end of the stent and were in a free state.The hospital had to perform a second surgery to perform endarterectomy to remove the stent and remaining stent fragments.

Manufacturer Narrative

Continuation of d10: product id: unk-ply-spider, product type: 0672-support and embolic protection.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.

Manufacturer Narrative

Additional information: the patient was admitted to the hospital and diagnosed with cerebral infarction and epileptic seizure.Carotid artery color ultrasound showed severe stenosis of the starting segment of the right carotid artery.Cta showed severe stenosis combined with thrombosis.After medical treatment, the patient's symptoms recurred.The vascular surgery department was invited for consultation, and it was suggested that the patient was at high risk for large-scale infarction.Carotid artery stripping treatment carried high risks.Interventional treatment was recommended and emergency interventional surgery was performed.Stent was inserted to treat carotid artery stenosis to prevent thrombus from escaping.During the surgery, the patient underwent stent implantation of the right internal carotid artery under the brain umbrella in strict accordance with the operating procedures and operating specifications.It was difficult to recover the distal protective device during surgery.After it was found that the tail end of the patient's stent was incomplete and the marker point at the tail end of the stent was displaced.After recovering the remote protection device, it was found that there was fragment of the stent remaining in the device.A re-examination of the ct revealed that the stent was incomplete at the opening of the proximal section of the stent, missing a marker point, and there was an excess mark point about 1/4 of the middle and upper section of the stent and there was still fragment of the stent attached to the surface of the stent inserted into the body.The patient had no special discomfort and reported device adverse event.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Image analysis the customer returned six images for evaluation.Image 1: this procedural image depicts stent placement in the common carotid artery, the spider device can also be visualised in the image.Image 2: this procedural image shows the stent deployed; it appears from the image that one of the radiopaque markers is detached from the proximal marker area.Image 3: this image depicts a hpc holding the filter basket of the spider fx device.A fragment of what appears to be a stent is attached to the filter basket of the spider device.Image 4: this procedural image shows the stent deployed.Image 5: this procedural image shows the spider device with a fragment of the stent in the filter basket.Image 6: this image depicts the product label of the protégé rx device, the details on the label match the product returned and the details on gch.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18767442
• MDR Text Key: 336111772
• Report Number: 2183870-2024-00063
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B650648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Date Device Manufactured: 11/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male