BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 1691090 · Received May 17, 2010

    Report

    Report Number
    9616099-2010-00365
    Event Type
    Death
    Date Received
    May 17, 2010
    Date of Event
    November 3, 2009
    Report Date
    November 19, 2009
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AN (B) (6) MALE WITH A HISTORY OF HYPERLIPIDEMIA, PAST SMOKING, HYPERTENSION AND CONTRALATERAL CAROTID OCCLUSION WAS ENROLLED IN THE (B) (4) REGISTRY. ANGIOGRAPHY REVEALED 99% STENOSIS IN THE OSTIUM OF HIS RIGHT INTERNAL CAROTID ARTERY. A PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION AND THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT. APPROXIMATELY 2 DAYS AFTER THE INDEX PROCEDURE, WHILE STILL IN THE HOSPITAL, THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA AND EXPIRED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO THE CORDIS PRODUCT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 14100043 WAS PERFORMED AND IT WAS FOUND THAT IT PRESENTED NO ISSUES DURING THE MANUFACTURING AND INSPECTION PROCESSES. TWO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 14100043. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. VENTRICULAR TACHYCARDIA CAN RESULT FROM NON-ISCHEMIA RELATED DISORDERS (SUCH AS VALVULAR HEART DISEASE OR ELECTRICAL CONDUCTION DISTURBANCES) AND IS OFTEN RELATED TO CORONARY ARTERY DISEASE, DRUG TOXICITY OR ELECTROLYTE ABNORMALITIES. AS NO REPORT OF A STENT-RELATED ISCHEMIC EVENT WAS RECEIVED, THERE IS NO EVIDENCE TO LINK THE ARRHYTHMIA TO THE IMPLANTED STENT. THERE IS NO MEDICAL EVIDENCE TO SUGGEST A RELATIONSHIP BETWEEN CAROTID STENT IMPLANTATION AND THE REPORTED CARDIAC EVENT.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DAY, THE PATIENT WAS NOTED TO HAVE DECREASED RESPONSIVENESS AND SIGNIFICANT HYPOTENSION, AND WAS TRANSFERRED INTO THE INTENSIVE CARE UNIT WHERE HE WAS TREATED WITH A DOPAMINE INFUSION, REPEATED FLUID BOLUSES, AND WAS TRANSFUSED WITH PACKED RED BLOOD CELLS. AN ABDOMINAL CT REVEALED ABDOMINAL AORTIC ANEURYSM WITH NO EVIDENCE OF ANEURYSM RUPTURE. APPROXIMATELY 2 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA AND PROGRESSED INTO A VENTRICULAR FIBRILLATION. CARDIOPULMONARY RESUSCITATION WAS INITIATED, BUT THE PATIENT EXPIRED. THE PRELIMINARY CONCLUSION FROM THE AUTOPSY INDICATED THAT ¿THE CAUSE OF DEATH FOR THIS PATIENT WITH SEVERE CALCIFIC ATHEROSCLEROTIC VASCULAR DISEASE (CRITICAL BILATERAL CAROTID STENOSIS, 70-80% STENOSIS OF THE MID LAD AND 50% STENOSIS OF THE MID CIRCUMFLEX), CONCENTRIC LEFT VENTRICULAR HYPERTROPHY, EMPHYSEMATOUS LUNG CHANGES AND LATE SYSTEMIC HYPOTENSION, ANEMIA, SYNCOPE AND CARDIAC DYSRHYTHMIA, WAS MOST LIKELY MULTIFACTORIAL, RELATED TO THE AFOREMENTIONED DISEASE PROCESSES AND COMPLICATED BY THE PROCEDURE-ASSOCIATED SOFT TISSUE HEMORRHAGE AND HEMATOMA (CLOTTED BLOOD MEASURING 575GMS) OF THE RIGHT GROIN CONSISTENT WITH EARLY ACUTE COMPARTMENT SYNDROME.¿ THE CERTIFICATE OF DEATH LISTED SUSTAINED VENTRICULAR TACHYCARDIA AS THE IMMEDIATE CAUSE OF DEATH. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 10/15/2010 VIA THE CRF INDICATED THAT THE INVESTIGATOR FELT THE DEATH WAS POSSIBLY RELATED TO THE INDEX PROCEDURE, BUT NOT CORDIS PRODUCT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B) (4) REGISTRY, A PATIENT EXPERIENCED VISUAL CHANGES, DECREASED RESPONSIVENESS AND SIGNIFICANT HYPOTENSION AFTER THE INDEX PROCEDURE AND EXPIRED DUE TO VENTRICULAR TACHYCARDIA APPROXIMATELY 2 DAYS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 99% STENOSIS IN THE OSTIUM OF HIS RIGHT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS 7MM IN LENGTH, SEVERELY CALCIFIED, ECCENTRIC, AND ULCERATED. THE REFERENCE VESSEL WAS 5MM IN DIAMETER AND SEVERELY TORTUOUS. AN ANGIOGUARD RX WITH A 6MM BASKET WAS DEPLOYED PAST THE TARGET LESION, AND THE LESION WAS PRE-DILATED. A 10 X 30MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION WITH 20% RESIDUAL STENOSIS. THE PATIENT DEVELOPED A SIGNIFICANT RIGHT GROIN HEMATOMA DURING THE PROCEDURE. MANUAL COMPRESSION WAS APPLIED TO THE GROIN SITE AND PROTAMINE SULFATE WAS ADMINISTERED. A NON-CORDIS SHEATH WAS USED FOR THE PROCEDURE AND THE HEMATOMA WAS DOCUMENTED AS A NON-COMPLAINT. FOLLOWING THE STENT PLACEMENT, THE PATIENT EXPERIENCED SOME VISUAL CHANGES, BUT A HEAD CT SHOWED NO ACUTE INTRACRANIAL ABNORMALITY.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B) (6) 2010 ALLEGING APPLY SAMPLE ON THEIR ONE TOUCH ULTRAMINI METER. THE PATIENT MENTIONED THAT ON (B) (6) 2010 AT 9:00AM, THE PATIENT NOTICED THE BLOOD SAMPLE WAS NOT BEING DRAWN IN ON THE TEST STRIPS. THE PATIENT CONTINUED TO TAKE THEIR USUAL DOSAGE OF MEDICATION (500 MG OF METFORMIN) AND AT 11:00AM, THE PATIENT FELT SWEATY AND DIZZY. THE PATIENT DRANK SOME ORANGE JUICE AND DID NOT SEEK ANY FURTHER MEDICAL ATTENTION. THIS WAS NOT THE FIRST TIME THE PRODUCT WAS BEING USED. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH A PROPER TEST AND THE ISSUE WAS NOT RESOLVED. THE METER WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT ALLEGED THAT DUE TO THE REPORTED ISSUE, AND BEING UNABLE TO TEST, APPROXIMATELY 2 HOURS LATER, THE PATIENT DEVELOPED SYMPTOMS AND HAD TO SELF-TREAT WITH JUICE.

    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 14100043

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R ASPIRIN, CLOPIDOGREL, HEPARIN