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 Hemorrhage/Bleeding (1888); Seizures (2063)

Event Date 03/29/2017

Event Type  Injury  

Manufacturer Narrative

Prediction of cerebral hyperperfusion after carotid artery stenting by cerebral angiography and single-photon emission computed tomography without acetazolamide challenge.Tsuyoshi ohta, md, phd; ichiro nakahara, md, phd; shojimatsumoto, md, phd; ryota ishibashi, md; harukamiyata, md; hidehisa nishi, md; s adayoshiwatanabe, md; izumi nagata,md, phd.Neurosurgery 81: 512¿519, 2017.Https://doi.Org/10.1093/neuros/nyx041.Average age.Majority gender.Estimate based on article publication date.If information is provided in the future, a supplemental report will be issued.

Event Description

The authors performed a retrospective study of patients undergoing an initial carotid artery stenting (cas) procedure for carotid artery stenosis.It was their intent to demonstrate the utility of single photon emission computed tomography (spect) in correlation with the patient¿s cerebral angiogram to assess the risk of cerebral hyperperfusion syndrome.Patients underwent strict regulation of each disease prior to treatment.Patients were prescribed 100 mg aspirin and 75 mg clopidogrel at least 3 days prior to the start of treatment.All treatments were performed under systemic heparinization, which was titrated to an activated clotting time of 250 to 350 s only during the procedure.Under distal protection with a balloon or filter wire, the stenosis was predilated with a 3.0 to 3.5 mm balloon catheter and a self-expanding stent deployed.Thirty seven cases received open-cell stents (out of a total of 100 cases), which consisted of 11 protege stents.Their findings were that preoperative asymmetry index (ai) on the spect and leptomeningeal anastomosis predicted cerebral hyperperfusion phenomenon (chp); and chp occurred in all case of cerebral hyperperfusion syndrome.The authors reported 9 patients of the included 100 patients who developed chp, and 5 of them had cerebral hyperperfusion syndrome.As the authors of the present article point out, this may be prevented by a more aggressive reduction in blood pressure at the time of revascularization.Anecdotally, it would appear more cases of chp are encountered in patients in which significant doses of antihypertensive agents are required to achieve an acceptable blood pressure.

• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7901359
• MDR Text Key: 121444703
• Report Number: 2183870-2018-00448
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/24/2018
• 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: 73 YR