BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2854094 · Received December 3, 2012

    Report

    Report Number
    9616099-2012-00713
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6) REGISTRY THE PATIENT EXPERIENCED CEREBRAL HYPERPERFUSION SYNDROME FOUR HOURS AFTER HAVING A PRECISE STENT PLACED IN THE PROXIMAL INTERNAL CAROTID ARTERY HAVING MILD CALCIFICATION, SEVERE TORTUOUSITY, A 90% STENOSIS AND 20MM IN LENGTH. THE PATIENT HAS A MEDICAL HISTORY OF FIRST-DEGREE RELATIVE WITH PREMATURE CAD SIGNIFICANT AORTIC ARCH DISEASE, HYPERLIPIDEMIA, HISTORY OF SMOKING, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION. THE PROCEDURE WAS UNREMARKABLE. AFTER THE PROCEDURE THE PATIENT PRESENTED WITH BEHAVIORAL CHANGES, ONSET OR DURATION OF THE SYMPTOMS WAS NOT INDICATED. THE PATIENT HAD DIFFICULTY WITH SPEECH FOR ABOUT THREE TO FOUR MINUTES, VISION CHANGES, HEADACHE, SHORT TERM MEMORY PROBLEMS AND DIFFICULTY TELLING TIME DIAGNOSED AS CEREBRAL HYPERPERFUSION SYNDROME. THE PATIENT WAS DISCHARGED 5 DAYS AFTER THE INDEX PROCEDURE WITHOUT ANY RESIDUAL SYMPTOMS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15571475 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. HYPERPERFUSION SYNDROME IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CAROTID STENT IMPLANTATION. NUMEROUS REPORTS HAVE DOCUMENTED THE RISK OF HYPERPERFUSION SYNDROME AFTER CAROTID ENDARTERECTOMY, CAROTID ANGIOPLASTY AND INTRACRANIAL ANGIOPLASTY. EVIDENCE FROM OBSERVATIONAL STUDIES SUGGESTS THAT A NUMBER OF FACTORS - ALL REFERABLE TO HEMODYNAMIC EXHAUSTION OF THE CEREBRAL CIRCULATION-PLAY A ROLE, SUCH AS RECENT STROKE, SURGERY FOR VERY TIGHT INTERNAL CAROTID ARTERY STENOSIS, CONCOMITANT CONTRALATERAL TIGHT LESION, IMPAIRED CEREBROVASCULAR RESERVE (CEREBRAL HYPOPERFUSION), AND MARKED POSTOPERATIVE INCREASE OF AN IPSILATERAL PEAK MIDDLE CEREBRAL ARTERY FLOW VELOCITY IN ADDITION TO PRE- AND POSTOPERATIVE HYPERTENSION. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE HYPERPERFUSION SYNDROME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, THE PATIENT EXPERIENCED A CEREBRAL HYPERPERFUSION SYNDROME FOUR HOURS AFTER THE INDEX PROCEDURE. THE PATIENT HAS A MEDICAL HISTORY OF FIRST-DEGREE RELATIVE WITH PREMATURE CAD SIGNIFICANT AORTIC ARCH DISEASE, HYPERLIPIDEMIA, HISTORY OF SMOKING, CORONARY ARTERY DISEASE, CORONARY PERCUTANEOUS REVASCULARIZATION. THE TARGET LESION, THAT WAS TREATED WITH PRECISE STENT AND AN ANGIOGUARD WAS USED, WAS THE PROXIMAL INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION, SEVERE TORTUOSITY, 90% STENOSIS AND 20MM IN LENGTH. THERE WAS NO PROBLEM DURING THE PROCEDURE. AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH BEHAVIORAL CHANGES, BUT THE UNSET OR DURATION OF THE SYMPTOMS WAS NOT INDICATED. THE PATIENT HAD BRIEF DIFFICULTY WITH SPEECH FOR ABOUT THREE TO FOUR MINUTES, VISION CHANGES, HEADACHE, SHORT TERM MEMORY PROBLEMS AND DIFFICULTY TELLING TIME. THE PATIENT WAS DIAGNOSED WITH CEREBRAL HYPERPERFUSION SYNDROME. THE SUBJECT'S PLAVIX AND ASPIRIN WERE HELD AND TO CONTROL THE BLOOD PRESSURE NITROGLYCERINE WAS SWITCH TO NITROPRUSSIDE. THE AFFECTED SIDE OF THE BRAIN WAS NOT INDICATED. THE PATIENT WAS DISCHARGE 5 DAYS AFTER THE INDEX PROCEDURE WITHOUT ANY SYMPTOMS. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15571475

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR