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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 04/03/2023

Event Type  Injury  

Event Description

Medtronic received a literature article on a case report titled 'stent migration after carotid artery stenting in long-term period: a rare complication'.A patient with hypertension, diabetes mellitus, coronary artery disease, and smoking had a dysarthria recovered within one hour.There were two lacunary infarctions in the left frontal lobe on diffusion-weighted magnetic resonance imaging.Computed tomography angiography (cta) showed 80% stenosis in the origin of the left internal carotid artery (ica).The patient was treated with acetylsalicylic acid (asa) 100 mg/day and clopidogrel 75 mg/day for two weeks before cas.Digital subtraction angiography (dsa) showed 65% stenosis in the origin of the left ica).The diameters of the common carotid artery (cca) and ica were respectively 5.7 mm and 3.6mm.A spider fx 5 mm (medtronic) distal protection device was deployed to distal cervical ica.Predilataion was applied to stenosis using a 3.5x15mm balloon inflated with 6 atm pressure.Then a protege 8-6x30mm stent (medtronic) was placed from ica to cca, covering the stenotic lesion.The patient was discharged with asa 100mg/day, clopidogrel 75mg/day, and atorvastatin 10 mg/day on the following day.Eights months later, the patient had a transient ischemic attack with mild weakness in the right upper extremity.Doppler ultrasonography (usg) showed a 70-99% restenosis in the distal segment of the stent on the left ica.There was severe stenosis in the cervical ica next to the stent on cta.Dsa showed downward migration of the stent on the left ica, with about 50% stenosis next to the stent.A spider fx 6 mm (medtronic) distal protection device was deployed to distal cervical ica.Mer 8-6x40 mm stent (non-medtronic) was placed from the cervical segment of ica to cca, covering the stenotic lesion.Then balloon angioplasty (post-dilatation) was applied with a 4.5x20 mm balloon catheter at 8 atm pressure.The patient was discharged home the following day with asa 100mg/day, clopidogrel 75mg/day, and atorvastatin 10 mg/day treatments.

Manufacturer Narrative

Stent migration after carotid artery stenting in long-term period: a rare complication; serhan yildirim; annals of clinical and analytical medicine, 2023;14 (suppl 1):s106-108.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): 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: 17433441
• MDR Text Key: 320124657
• Report Number: 2183870-2023-00272
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P060001
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2023
• 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: 71 YR
• Patient Sex: Male