BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1101643 · Received August 6, 2008

    Report

    Report Number
    9616099-2008-01931
    Event Type
    Death
    Date Received
    August 6, 2008
    Date of Event
    November 13, 2006
    Report Date
    July 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO CONTAINED IN A LITERATURE REVIEW INDICATED THAT A PT DIED OF SUDDEN CARDIAC DEATH AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE INDICATION FOR THE PROCEDURE WAS EXERTIONAL ANGINA AND ISCHEMIC CHANGES NOTED ON ECG. THE PT'S HISTORY WAS SIGNIFICANT FOR HYPERTENSION, DIABETES AND 20 PACK YEARS SMOKING. ANGIOGRAPHY REVEALED "CRITICALLY CALCIFIED STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), THE DISTAL LEFT MAIN (LM), AND THE PROXIMAL TO MIDDLE LEFT CIRCUMFLEX (LCX), AND SHOWED TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA) WITH GRADE II COLLATERALS FROM LEFT CORONARY ARTERY. THE GOAL WAS TO TREAT THE RCA INITIALLY AND THEN THE LAD AND THE CFX IN A STAGED PLANNED PROCEDURE. THE TARGET LESION OF THE RCA WAS PRE-DILATED FOLLOWED BY A 2.75MM X 33MM CYPHER STENT DEPLOYED IN THE MID-DISTAL RCA. A 3.0MM X 33MM CYPHER WAS THEN DEPLOYED PROXIMAL AND OVERLAPPING THE FIRST STENT. THE INFLATION PRESSURES WERE 10-14 ATMS. THE PT WAS BROUGHT BACK FOR PCI TO THE LAD AND CFX TWO DAYS LATER. A 2.75MM 33MM CYPHER WAS IMPLANTED IN THE CFX WITH KISSING BALLOON TECHNIQUE AND LAD INCLUDING D-LM USING A 3.5MM X 23MM CYPHER STENT WITH CROSS-OVER TECHNIQUE. FINAL ANGIOGRAM REVEALED OPTIMAL STENT EXPANSION, HOWEVER, STENT FRACTURE WAS OBSERVED IN THE STENT IMPLANTED IN THE DISTAL RCA. THE TREATMENT FOR THIS OBSERVATION IS UNK. FOLLOW UP CAG WAS PERFORMED ONE YEAR LATER AND REVEALED NO CRITICAL IN-STENT RESTENOSIS INCLUDING IN THE PREVIOUSLY FRACTURED STENT, BUT MULTIPLE ADDITIONAL FRACTURES WERE OBSERVED IN THE RCA AND CFX. MEDICAL MANAGEMENT WAS DECIDED UPON FOR TREATMENT. THE PT DIED TWO MONTHS LATER IN HIS SLEEP. "WE SUPPOSED THAT HIS SUDDEN CARDIAC DEATH MIGHT BE OWING TO STENT THROMBOSIS." THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING A CORONARY STENT. CARDIOVASCULAR DISEASE IS THE MOST COMMON REASON FOR PT'S TO DIE SUDDENLY. HALF OF ALL SUDDEN CARDIAC DEATHS ARE RELATED TO ATHEROSCLEROSIS AS WELL AS HALF RELATED TO CARDIAC ENLARGEMENT IN PTS WITH HYPERTENSION. THERE IS NO CONCLUSIVE EVIDENCE IN THE LITERATURE REVIEW TO CONFIRM THAT A THROMBOTIC EVENT HAD OCCURRED. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT PT FACTORS WITH THE PROGRESSION OF CARDIAC DISEASE MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2007-00209, 9616099-2008-01931, 01932, AND 01933. THIS CYPHER SIROLIMUS-ELUTING CORONARY STENTS IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS FOUND IN A LITERATURE REVIEW: THIS MALE PT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION DUE TO CRITICAL STENOSIS OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD), THE DISTAL LEFT MAIN (LM) AND THE PROXIMAL TO MID LEFT CIRCUMFLEX (LCX) AS WELL AS A TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA) WITH GRADE II COLLATERALS FROM THE LEFT CORONARY ARTERY. HE HAD FOUR CYPHER STENTS IMPLANTED; A 2.75 X 33 IN THE MID-DISTAL RIGHT CORONARY ARTERY, A 3.0 X 33MM IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY, A 2.75 X 33MM IN THE LEFT CIRCUMFLEX AND 3.5 X 23MM IN THE DISTAL LEFT MAIN TO THE LEFT ANTERIOR DESCENDING. TWO DAYS POST PROCEDURE, DEFINITE FRACTURE OF THE STENT IMPLANTED IN THE RIGHT CORONARY ARTERY WAS DETECTED. DURING THE ONE-YEAR FOLLOW-UP, A CORONARY ANGIOGRAPHY WAS PERFORMED WHICH SHOWED NO CRITICAL IN-STENT RESTENOSIS, INCLUDING PREVIOUSLY FRACTURED LESION, NOR DE NOVO LESION, HOWEVER, MULTIPLE STENT FRACTURES IN THE STENTS PREVIOUSLY IMPLANTED IN THE RCA AND LCX WERE DETECTED. AT THAT TIME, MYOCARDIAL PERFUSION SPECT DID NOT SHOW ANY MYOCARDIAL ISCHEMIA. THE PT WAS GIVEN MEDICAL TREATMENT, WHICH INCLUDED 100MG OF ASPIRIN AND 75MG OF CLOPIDOGREL. UNFORTUNATELY, TWO MONTHS LATER, THE PT DIED SUDDENLY IN HIS SLEEP. IT IS SUPPOSED THAT HIS SUDDEN CARDIAC DEATH MIGHT BE OWING TO STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death