BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1216486 · Received October 30, 2008

    Report

    Report Number
    9616099-2008-02583
    Event Type
    Death
    Date Received
    October 30, 2008
    Date of Event
    January 22, 2008
    Report Date
    March 12, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN'S COMMENT REGARDING THE PROBABLE CAUSE OF THE THROMBOTIC EVENT (VLT) WAS THAT IT WAS UNKNOWN DUE TO THE NUMBER OF STENTS IMPLANTED AND THE PATIENT DID NOT EXHIBIT SYMPTOMS OF DEHYDRATION OR INFECTIOUS DISEASE. THE PHYSICIAN STATED THE PROBABLE CAUSE OF DEATH WAS DUE TO CARDIAC ARREST BECAUSE OF ACUTE MYOCARDIAL INFARCTION. APPROXIMATELY NINE MONTHS PRIOR TO THE PMS STUDY PROCEDURE THE PATIENT HAD A DURAFLEX BMS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). AN ADDITIONAL DEVICE WAS IMPLANTED IN THE ATRIO-VENTRICULAR (AV) BRANCH OF THE RCA. ONE MONTH LATER AND APPROXIMATELY EIGHT MONTHS PRIOR TO THE STUDY PROCEDURE, AN EXPRESS BMS WAS IMPLANTED IN THE OM. FOUR MONTHS LATER AND APPROXIMATELY FOUR MONTHS PRIOR TO THE STUDY PROCEDURE, THE PATIENT HAD AN ELECTIVE PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT THE PROXIMAL/MID LEFT ANTERIOR DESCENDING (LAD) TARGET LESION. THE LESION WAS REPORTED TO BE: TWO SEPARATE LESIONS, 15 MM LENGTH, 2.5 MM VESSEL DIAMETER, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.5 X 14 MM BALLOON AT 12 ATM FOR 60 SEC. A CYPHER 2.5 X 18 MM STENT (CYPHER STENT #1) WAS IMPLANTED AT 15 ATM FOR 35 SEC. AN ADDITIONAL CYPHER 2.5 X 18 MM STENT (SAME LOT NUMBER/CYPHER STENT #2) WAS IMPLANTED AT 12 ATM FOR 30 SEC IN OVERLAPPING FASHION. THE STENTS WERE POST-DILATED WITH A 22.5 X 14 MM BALLOON AT 18 ATM FOR 25 SEC. IVUS WAS NOT DONE. AN ACT WAS NOT MEASURED. THE RESIDUAL STENOSIS WAS 0%. THE TIMI FLOWS WERE UNKNOWN. THERE WERE NO REPORTED PRODUCT MALFUNCTIONS OR ADVERSE EVENTS FOR THIS PROCEDURE. NINE DAYS PRIOR TO THE PMS STUDY PROCEDURE, A PCI WAS DONE TO TREAT THE MID RCA AND AV BRANCH OF THE RCA. THE MID RCA LESION WAS REPORTED TO BE: AN ISR OF A PREVIOUSLY IMPLANTED BMS/DURALFLEX, 20 MM LENGTH, 2.5 MM VESSEL DIAMETER, AND TYPE B2. THE MID RCA LESION WAS PRE-DILATED WITH A 2.5 X 14 MM BALLOON AT 10 ATM FOR 30 SEC. A CYPHER 2.5 X 23 MM STENT (CYPHER STENT #3) WAS IMPLANTED AT 15 ATM FOR 30 SEC. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE AV BRANCH TARGET LESION WAS REPORTED TO BE: AN ISR OF A PREVIOUSLY IMPLANTED 15 MM LENGTH, VESSEL DIAMETER 2.5 MM, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.5 X 14 MM BALLOON AT 10 ATM FOR 15 SEC. A CYPHER 2.5 X 18 MM STENT (CYPHER STENT #4) WAS IMPLANTED AT 14 ATM FOR 30 SEC. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. IVUS WAS NOT DONE. AN ACT WAS NOT MEASURED. THE FLOW POST-PROCEDURE WAS TIMI 3. THERE WERE NO REPORTED PRODUCT MALFUNCTIONS OR ADVERSE EVENTS FOR THIS PROCEDURE. IN 2004, THE INDEX PROCEDURE FOR THE STUDY WAS AN ELECTIVE CASE. THE RADIAL APPROACH WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS THE OBTUSE MARGINAL BRANCH. THE TARGET LESION WAS REPORTED TO BE: DE NOVO, ECCENTRIC, DIFFUSELY DISEASED, NOT CALCIFIED, AN 86% STENOSIS, 20.07 MM IN LENGTH, NOT A BIFURCATION LESION, ABSENT OF PRE-EXISTING CLOT, NOT TORTUOUS, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.5/20 MM BALLOON AT 12 ATM, INFLATION TIME UNKNOWN. TWO (2) CYPHER 2.5/18 MM STENTS (CYPHER STENTS #5 AND #6/SAME LOT NUMBER) WERE DEPLOYED AT 18 ATM FOR 15 SEC IN OVERLAPPING FASHION. THE STENTS WERE NOT POST-DILATED. THE FLOW PRE-PROCEDURE WAS TIMI 2, AND POST-PROCEDURE TIMI 3. THE RESIDUAL STENOSIS WAS 29%. AE#1: THE FIRST ADVERSE EVENT (AE#1/THAT WAS ALL READY REPORTED PREVIOUSLY) OCCURRED APPROXIMATELY FIFTEEN WEEKS AFTER THE STUDY INDEX PROCEDURE. THE PATIENT COMPLAINED OF CHEST PAIN AND HAD CORONARY ANGIOGRAPHY DONE SEVENTEEN DAYS LATER. THE PREVIOUSLY IMPLANTED CYPHER 2.5 X 18 MM STUDY PROCEDURE STENTS WERE FOUND TO HAVE A 100% ISR IN THE MIDDLE OF BOTH STENTS. THE RESTENOSIS WAS TREATED BY BALLOON ANGIOPLASTY WITH A 2.25 X 20 MM BALLOON AT 20 ATM FOR 120 SEC. THE RESIDUAL STENOSIS WAS 25%. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE IN STABLE CONDITION. AE#2 (PREVIOUSLY REPORTED) : THE AE OCCURRED APPROXIMATELY TWENTY-SIX MONTHS AFTER THE STUDY PROCEDURE. THE PATIENT COMPLAINED OF CHEST PAIN. CORONARY ANGIOGRAPHY WAS DONE AND A 99% IN-STENT RESTENOSIS WAS OBSERVED AND EXTENDED TO THE DISTAL EDGE OF THE PREVIOUSLY IMPLANTED CYPHER 2.5 X 18 MM STUDY STENT(S) IN THE OM TARGET LESION. SIX DAYS AFTER THE ANGIOGRAM, THE RESTENOSIS WAS TREATED BY BALLOON ANGIOPLASTY USING A 2.25 MM BALLOON/LENGTH UNKNOWN. THE RESIDUAL STENOSIS WAS 25%. A CYPHER 2.5 X 18 MM STENT (CYPHER STENT #7) WAS IMPLANTED IN THE MID LAD TARGET LESION. NO ADDITIONAL DETAILS WERE AVAILABLE. THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE INTERVENTION. AE#3 (PREVIOUSLY REPORTED) : APPROXIMATELY THIRTY-SIX MONTHS AFTER THE STUDY INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND HAD AN ADDITIONAL CORONARY ANGIOGRAM. THE SAME SEGMENT AS MENTIONED ABOVE IN AE#2 WAS OBSERVED TO AGAIN DEMONSTRATE A 99% IN-STENT RESTENOSIS THAT EXTENDED TO THE DISTAL EDGE OF THE STENT(S). ONE WEEK LATER, THE RESTENOSIS WAS TREATED BY IMPLANTATION OF A TAXUS 2.5 X 24 MM DRUG ELUTING STENT (DES) INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENTS TO THE DISTAL EDGE (OF THE OBTUSE MARGINAL TARGET LESION). THE RESIDUAL STENOSIS WAS 0%. DURING THE SAME PROCEDURE, TWO ADDITIONAL DE NOVO LESIONS WERE OBSERVED IN THE PROXIMAL CIRCUMFLEX AND PROXIMAL RCA. BALLOON ANGIOPLASTY WITH AN UNKNOWN BALLOON WAS DONE BUT A DISSECTION OCCURRED. A BMS/DRIVER 3.5 X 15 MM STENT WAS IMPLANTED IN THE LEFT MAIN TRUNK (LMT))/PROXIMAL CIRCUMFLEX IN OVERLAPPING FASHION WITH THE PREVIOUSLY IMPLANTED CYPHER STENTS IN THE OM BRANCH. THE PROXIMAL RCA LESION WAS TREATED BY IMPLANTATION OF A CYPHER 3.0 X 33 MM STENT (STENT #8)/DETAILS UNKNOWN. THE PATIENT WAS DISCHARGED FOUR DAYS AFTER THE INTERVENTION. THE PHYSICIAN'S COMMENT REGARDING THE PROBABLE CAUSE OF THE ADDITIONAL AE'S WAS THAT THEY MIGHT BE DUE TO THE FACT THE STENTS WERE IMPLANTED IN A SMALL VESSEL. APPROXIMATELY FORTY-ONE MONTHS AFTER THE STUDY INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN IN THE MORNING. THE PATIENT WAS TAKEN EMERGENTLY TO THE HOSPITAL WITH AN ACUTE MYOCARDIAL INFARCTION (AMI) WITH CARDIOPULMONARY ASSISTANCE (CPA) BEING CONDUCTED. ON ARRIVAL TO THE HOSPITAL, PERIPHERAL CARDIOPULMONARY SUPPORT (PCPS) AND CORONARY ANGIOGRAPHY WAS DONE. THROMBUS WAS OBSERVED IN THE PREVIOUSLY IMPLANTED STENTS IN THE OM BRANCH AND THE PROXIMAL CIRCUMFLEX. THE THROMBOSIS WAS TREATED BY BALLOON ANGIOPLASTY USING A KISSING BALLOON TECHNIQUE (KBT): A 3.5 MM BALLOON AT THE LEFT AMIN/PROXIMAL LAD AND A 3.0 MM BALLOON FOR THE LEFT MAIN/PROXIMAL CIRCUMFLEX. A BMS/LIBERTE 3.5 X 16 MM STENT WAS IMPLANTED IN THE LEFT MAIN/PROXIMAL LAD. THE PROXIMAL/MID RCA WAS TREATED BY BALLOON ANGIOPLASTY USING A 3.5 MM BALLOON. THE PROXIMAL CIRCUMFLEX WAS TREATED BY BALLOON ANGIOPLASTY ONLY AS THE PHYSICIAN DID NOT WANT TO PROLONG THE PROCEDURE AND THE TIMI FLOW DID NOT IMPROVE DESPITE PCPS. AFTER THE PROCEDURE, AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED AND THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT'S CARDIOPULMONARY FUNCTION DID NOT RECOVER AND THE PATIENT DEVELOPED ANURIA. CONTINUOUS HEMODIFILTRATION WAS STARTED THE DAY AFTER THE PROCEDURE. TEN DAYS AFTER ADMISSION FOR THIS EVENT, THE WHOLE CONDITION OF THE PATIENT WORSENED GRADUALLY AND THE PATIENT EXPIRED. PLEASE NOTE THAT THE DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT: THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE ALSO NOTE THAT THIS COMPLAINT FILE WAS PREVIOUSLY REPORTED AS PQMS FILE AND MFR. #9616099-2005-01392. THE PATIENT HAD A TOTAL OF EIGHT CYPHER STENTS IMPLANTED. PLEASE REFERENCE MFR. REPORT # 9616099-2005-01392, #9616099-2008-02580, # 9616099-2008-02581, #9616099-2008-02582, # 9616099-2008-02584, AND #9616099-2008-00937.

    Description of Event or Problem · 1

    ADD'L INFO WAS REC'D FROM THE AFFILIATE REGARDING THIS PT IN THE CLINICAL STUDY. THE INDEX PROCEDURE FOR THE STUDY WAS DONE IN 2004. THE PT EXPIRED APPROX FORTY-ONE (41) MONTHS AFTER THE STUDY INDEX PROCEDURE, DUE TO CARDIAC ARREST FROM AN ACUTE MYOCARDIAL INFARCTION AND VERY LATE STENT THROMBOSIS (VLT). NO AUTOPSY WAS CONDUCTED. THE PT HAD A TOTAL OF FOURTEEN ASSORTED STENTS IMPLANTED IN DIFFERENT TARGET LESIONS: FIVE BARE METAL STENTS (BMS), EIGHT CYPHER STENTS, AND ONE TAXUS STENT. THE ADD'L INFO REC'D INCLUDED INFO PRIOR TO THE CLINICAL STUDY. FOR THE CLINICAL STUDY THE PT HAD TWO CYPHER 2.5 X 18 MM STENTS IMPLANTED IN THE OBTUSE MARGINAL (OM) BRANCH TO TREAT AN IN-STENT RESTENOSIS (ISR) OF A PREVIOUSLY IMPLANTED BARE METAL/EXPRESS STENT (BMS) FOR THE STUDY PROCEDURE. THE PT HAS HAD THREE PREVIOUSLY REPORTED ADVERSE EVENTS OF RESTENOSIS INVOLVING THESE TWO PREVIOUSLY IMPLANTED (STUDY) CYPHER STENTS.

    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 74 YR Death| H| L| R 2.5 X 30 MM BALLOON