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

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.

• 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 Key: 12569294
• MDR Text Key: 281442465
• Report Number: 2183870-2021-00366
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• 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 Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR