BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2970237 · Received February 20, 2013

    Report

    Report Number
    9616099-2013-00079
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 28, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. CONCOMITANT DEVICES: ANGIOGUARD RX: CATALOG NUMBER 501814RMC, LOT NUMBER 70612471S.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE FOLLOWING CARDIAC AND LAB VALUES: POST-PROCEDURE, ON (B)(6) 2013 AT 15:46, THE TROPONIN WAS 1.31. ON (B)(6) 2013 AT 16:18, THE CK WAS 153 (NL 300, RATIO <1). ON (B)(6) 2013 AT 01:00, THE TROPONIN WAS 0.80, AND ON (B)(6) 2013 AT 06:15, THE TROPONIN WAS 0.06. ON (B)(6) 2013, THE CK WAS 119 (NL 300, RATIO <1) AND THE CKMB WAS 5.8 (NL 6.7, RATIO <1). THE SITE REPORTED ECG CHANGES INCLUDING ST DEPRESSION AND T WAVE INVERSION IN I, II AND LATERAL LEADS. THE PATIENT WAS DIAGNOSED WITH NSTEMI BASED ON TROPONIN ELEVATION. THE TTE ON (B)(6) 2013 REVEALED EF OF 60-65%, A VERY SUBTLE WALL MOTION ABNORMALITY IN THE BASAL INFEROLATERAL WALL (UNCHANGED) AND NO SIGNIFICANT CHANGE ON LV FUNCTION SINCE PRIOR ECHOCARDIOGRAM. ADDITIONAL INFORMATION IS NOT AVAILABLE AND FURTHER REPORTS WILL NOT BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6) REGISTRY THE PATIENT EXPERIENCED A NON Q WAVE MYOCARDIAL INFARCTION THE SAME DAY AS THE INDEX PROCEDURE. THE PATIENT IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING SYNCHRONOUS, SEVERE CARDIAC AND CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION, FIRST-DEGREE RELATIVE WITH PREMATURE CAD (FEMALE 140 AND HYPERTENSION WITH DIASTOLIC>90, OR REQUIRING MEDICATION. CAS WAS PERFORMED ON A 72% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY OF 20MM IN LENGTH IN A 4.8MM VESSEL DIAMETER WITH MILD VESSEL TORTUOSITY. THE ARCH II LESION WAS MILDLY CALCIFIED, ULCERATED AND ECCENTRIC. A 5MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED PAST THE LESION, THE LESION WAS PRE-DILATED AND AN 8X40MM PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS WAS 15%. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED 4 DAYS LATER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS HAD MULTIPLE CABGS BEFORE, AND IS ALSO GOING TO UNDERGO AN AORTIC VALVE REPLACEMENT IN THE FUTURE. DUE TO THE INCREASE IN CARDIAC ENZYMES, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION WHICH SHOWED THERE IS 3 VESSEL CORONARY DISEASE AND SIGNIFICANT LEFT MAIN CORONARY ARTERY STENOSIS. NO OTHER TREATMENT WAS PERFORMED AT THE TIME, THE PATIENT HAS BEEN RECOMMENDED FOR PERCUTANEOUS CORONARY INTERVENTION TO REPLACE HIS AORTIC VALVE. THE PATIENT WAS BACK TO BASELINE AT DISCHARGE. THE PRODUCT REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. MI IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTING. FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT'S MEDICAL HISTORY OF CAD INCLUDING PREVIOUS CABG PROCEDURES AND HYPERTENSION. POSSIBLE PHARMACOLOGICAL FACTORS CONTRIBUTING TO THE EVENT MAY ALSO INCLUDE THE PATIENT'S COMPLIANCE WITH THE MEDICATION REGIMEN AND DISCONTINUATION OF ANTI-PLATELET THERAPY. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6), THE PATIENT EXPERIENCED A NON Q WAVE MYOCARDIAL INFARCTION THE SAME DAY AS THE INDEX PROCEDURE. CAS WAS PERFORMED ON A 72% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY OF 20 MM IN LENGTH IN A 4.8 MM VESSEL DIAMETER WITH MILD VESSEL TORTUOSITY. THE ARCH II LESION WAS MILDLY CALCIFIED, ULCERATED AND ECCENTRIC. A 5 MM MEDIUM SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS DEPLOYED PAST THE LESION, THE LESION WAS PRE-DILATED AND AN 8 X 40 MM PRECISE PRO RX STENT WAS DEPLOYED AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS WAS 15%. THERE WAS NO DOCUMENTED DISSECTION OR PRESENCE OF AIR BUBBLES DURING THE PROCEDURE. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED 4 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73736 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15718776

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening