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U.S. Department of Health and Human Services

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

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COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ischemia Stroke (4418)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article was submitted detailing a presenting a case of a patient who presented with subarachnoid hemorrhage (sah) due to a ruptured right a1 dissecting aneurysm.The patient presented with sudden onset of severe headache and disturbance of consciousness.The aneurysm was trapped; however, 7 days after the onset of sah, the patient experienced right hemiparesis and aphasia.Angiography showed left ica dissection.Urgent carotid artery stenting was performed, and a protégé rx stent was placed leading to symptom improvement.Before the procedure, the patient was administered 200 mg aspirin and 300 mg clopidogrel to prevent thrombotic complications.Complete coverage of the dissected segment of the left ica was achieved using the protégé rx stent.Blood flow in the left ica improved, and it was checked for restenosis and acute in-stent thrombosis.The patient¿s symptoms disappeared postoperatively.Postoperative magnetic resonance imaging showed left cerebral infarction in the anterior watershed area; however, symptomatic cerebral vasospasm and secondary hydrocephalus did not occur.Abdominal cta showed dissecting aneurysms of the celiac and superior mesenteric arteries.Segmental arterial mediolysis (sam) was strongly suspected because of the lack of features characteristic of other diseases and radiographic findings of multiple non-consecutive dissecting lesions.The patient underwent cranioplasty, and on day 46 after sah, and patient was discharged with no neurological deficits.At present, the patient is undergoing regular follow-up imaging to monitor the left va, celiac artery, and superior mesenteric artery aneurysms.
 
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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 Key12569294
MDR Text Key281442465
Report Number2183870-2021-00366
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/04/2021
Initial Date FDA Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
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