BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2360085 · Received December 6, 2011

    Report

    Report Number
    9616099-2011-00907
    Event Type
    Injury
    Date Received
    December 6, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 15, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE (B)(4) INDICATED THAT THE PATIENT WAS HOSPITALIZED APPROXIMATELY SEVEN DAYS POST INDEX PROCEDURE WITH ADMISSION DIAGNOSIS OF NEW ONSET SEIZURES, PROBABLE RE-VASCULARIZATION SYNDROME, SUB-THERAPEUTIC COUMADIN & A-FIB WITH RVR. THE INDEX PROCEDURE CONSISTED OF PTA PERFORMED ON AN 80% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 20MM IN LENGTH IN A 6.0MM VESSEL DIAMETER. THE ARCH I LESION WAS MILDLY CALCIFIED, ECCENTRIC WITH MODERATE VESSEL TORTUOUSITY. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED, THE LESION WAS PRE-DILATED AND A 10X40MM PRECISE PRO RX LESION WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES. AT STUDY INCLUSION, NIH AND RANKIN SCORES WERE 3, RESPECTIVELY. THE PATIENT WAS ALSO SYMPTOMATIC AT THE TIME OF THE INTERVENTION. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITH THE NIH AND RANKIN SCORES UNCHANGED. 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 15178904 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. TRANSIENT CEREBRAL HYPEREMIA MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS AND CAN LEAD TO SEVERE UNILATERAL HEADACHE, FACE AND EYE PAIN, CONFUSION, SEIZURES, FOCAL NEUROLOGIC DEFICITS, AND INTRACEREBRAL HEMORRHAGES. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS FACTORS THAT MAY HAVE INFLUENCED THIS EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: HEPARIN AND LOW MOLECULAR WEIGHT HEPARIN WERE GIVEN DURING THE PROCEDURE. POST-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL. ASPIRIN WAS ALSO GIVEN POST-PROCEDURE. CONCOMITANT DEVICES: 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS HOSPITALIZED APPROXIMATELY SEVEN DAYS POST INDEX PROCEDURE WITH ADMISSION DIAGNOSIS OF NEW ONSET SEIZURES, PROBABLE RE-VASCULARIZATION SYNDROME, SUB-THERAPEUTIC COUMADIN AND A-FIB WITH RVR. THE PATIENT WAS GIVEN 5 MG OF ATIVAN TO TREAT THE SEIZURE ACTIVITY. THE PATIENT WAS DISCHARGED TO AN EXTENDED CARE FACILITY VIA AMBULANCE ON (B)(6) 2011 AT 14:22. AT STUDY INCLUSION, NIH AND RANKIN SCORES WERE 3, RESPECTIVELY. THE PATIENT WAS ALSO SYMPTOMATIC AT THE TIME OF THE INTERVENTION. PTA WAS BEING PERFORMED ON AN 80% OCCLUDED LESION IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY OF 20MM IN LENGTH IN A 6.0MM VESSEL DIAMETER. THE ARCH I LESION WAS MILDLY CALCIFIED, ECCENTRIC WITH MODERATE VESSEL TORTUOSITY. A 6MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED, THE LESION WAS PRE-DILATED AND A 10X40MM PRECISE PRO RX LESION WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY WITH THE NIH AND RANKIN SCORES UNCHANGED.

    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 15178904

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L