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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 06/23/2014

Event Type  Injury  

Manufacturer Narrative

Authors: moisey aronov, natalia s shevchenko, natalia a amosova article: acute three-vessel cervical arterial occlusion due to spontaneous quadruple cervical artery dissection journal: bmj case reports, 2014 literature reference: 10.1136/bcr-2014- 203725.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.

Event Description

A patient presented to the emergency department with 12 h history of mild right-sided hemiparesis and motor aphasia.In our practice, routine acute stroke mri protocol includes t1, t2, fluid attenuated inversion recovery, diffusion weighted imaging (dwi) and angiographic regimens.Dwi and mr angiography revealed acute focal ischemia in the left frontoparietal region consistent with decreased blood supply through left carotid artery (figure 1).Further ct angiography (cta) revealed occlusion of left internal carotid artery (ica).There were no signs of occlusion, stenosis or dissection in other major vessels.After initial workup, the patient remained stable with glasgow coma scale (gcs) score of 15.Arterial dissection was suspected.Considering more than 12 h history of symptoms, medical management with anticoagulants was initiated.The patient was admitted to the neurological intensive care unit for observation.On second day of hospitalization, the patient¿s condition rapidly deteriorated with acute onset of left-sided hemiparesis and gcs score of 8.She was intubated and taken to the intervention radiology operating room within 90 min of symptom onset.Treatment digital subtracted angiography (dsa) revealed complex pattern of brain blood supply (figure2): left ica was occluded.Right ica was also occluded with typical for dissection flame-like shape.Left vertebral artery (va) was occluded at c2 level.Intracranial supply of left va partially was compensated by anastomosis from muscular cervical arterial branch.Right va was functional.However, there was irregularity of contrast filling indicating arterial dissection.Thus, brain blood supply was entirely dependent on dissected right va.Owing to progressing neurological deterioration, a decision was taken to perform revascularization.Since symptoms manifested with left-sided hemiparesis, right ica was intervened on.Catheterization of right ica distally to occlusion was performed with non-medtronic microcatheter, followed by one pass thrombextraction with non-medtronic stent.Although no thrombotic masses were removed, antegrade flow appeared in right ica.Self-expanded stent protégé was placed to complete restoration of right ica lumen (figure 3).Outcome and follow-up new neurological deficit was resolved in the immediate postoperative period.There wereno new signs of right-sided ischemia on mri.The patient remained on dual antiplatelet and anticoagulant therapy.She also received a course of neurological rehabilitation.Two weeks later, dsa of all vessels was performed revealing the following changes: small antegrade flow in left ica.Antegrade flow in left va.Normally functioning previously stented right ica.Persistent signs of dissection in right va.Stenting of right va with appropriate size non-medtronic stent was performed at the site of dissection.During in-hospital neurological rehabilitation, aphasia and right-sided hemiparesis improved gradually and fully resolved at discharge.The patient was sent home neurologically intact and on dual antiplatelet therapy.At a 3-month follow-up, cta revealed in-stent thrombosis of right ica.However, other three arteries functioned normally.Left ica and left va had adequate blood supply to the brain.The patient remained neurologically intact.Blood workup showed positive thrombophilic markers: pai (hom), gp 1a (het), mtgfr (het), mtr (het), mtrr (het), f xiii (het).The patient was referred to a hematologist and received antithrombin-iii ×1000me three times.Since then she has been on clopidogrel 75 mg daily.More than 1 year after her surgery, the patient has continued to do wellclinically.

Manufacturer Narrative

Image analysis the customer returned one scanned article ¿acute three-vessel cervical arterial occlusion due to spontaneous quadruple cervical artery dissection¿ with reference to the reported event.As reported the physician used ¿.Self-expanded stent protégé was placed to complete restoration of right ica lumen (figure 3)¿.The article goes on to explain figure 3 ¿figure 3 digital subtracted angiography, stages of right internal carotid artery (ica) revascularisation.(a) lateral view: microcatheter passed the occlusion, contrasting the distal part of right ica.(b) after one pass of stent extraction direct flow appeared, showing irregular dissected vessel wall.(c) after self-expandable nitinol 6×8 × 40 mm, stent implantation lumen of right ica restored¿.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
• 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: 15264927
• MDR Text Key: 298292141
• Report Number: 2183870-2022-00268
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• 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: 32 YR
• Patient Sex: Female