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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2022

Event Type  malfunction  

Event Description

Medtronic received a literature article reporting a case study titled 'proximal migration of a tapered open-cell stent after carotid artery stenting for restenosis following endarterectomy'.A patient with a history of radiation therapy for tongue cancer approximately 10 years earlier visited a hospital because of transient left upper limb hemiparesis.They were diagnosed with transient ischemic attack owing to severe stenosis of the right cervical internal carotid artery and was referred to our hospital.Computed tomography angiography revealed 86% stenosis.Other causes were ruled out.Symptomatic radiation-induced carotid artery stenosis and performed carotid endarterectomy with a patch graft was diagnose.Six months later, restenosis was observed at the distal end of the operative site.Angiography also showed maximum 80% stenosis at another angle.Therefore, carotid artery stenting (cas) with distal balloon protection was performed.A self-expandable tapered-design open cell stent (protege rx 10/7 mm x 40 mm; medtronic) was selected because of the large difference in proximal (7.4 mm) and distal (2.8 mm) vessel diameters.After balloon angioplasty the stent was deployed centered on the stenotic lesion within the internal carotid artery.Additional balloon angioplasty was performed after stenting and obtained adequate dilatation (5% residual stenosis).Computed radiography on the second day after the procedure showed downward migration of the stent.Computed tomography angiography confirmed that the stenosis was dilated and covered with the stent.Six months after stent placement, angiography showed no recurrent stenosis and stable stent position.During the 3- year follow-up period after cas, no restenosis or further stent migration was observed.

Manufacturer Narrative

Title: proximal migration of a tapered open-cell stent after carotid artery stenting for restenosis following endarterectomy journal.Journal of stroke and cerebrovascular diseases issue: 2023, vol.32, no.3 reference: doi.Org/10.1016/j.Jstrokecerebrovasdis.2022.106953.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.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16520207
• MDR Text Key: 311110559
• Report Number: 9612164-2023-01061
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2023
• 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