BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1080224 · Received July 21, 2008

    Report

    Report Number
    3003742446-2008-00132
    Event Type
    Death
    Date Received
    July 21, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE "SPONTANEOUS CORONARY ARTERY PERFORATION SECONDARY TO A SIROLIMUS-ELUTING STENT INFECTION" WAS PUBLISHED IN THE JOURNAL OF INVASIVE CARDIOLOGY VOL. 19, NO.10, OCTOBER 2007, PAGES E303-E306. PLEASE NOTE THAT THIS IS FOR THREE PRODUCTS WITH UNK LOT NUMBERS. THE PRODUCTS ARE NOT AVAILABLE FOR EVALUATION AND TESTING. INFO CONTAINED IN A LITERATURE REVIEW INDICATED THAT A PT EXPERIENCED AN INFECTED STENT AND SPONTANEOUS CORONARY ARTERY PERFORATION. A PT WAS ADMITTED FOR NON-ST ELEVATION MI, ANGIOGRAPHY WAS PERFORMED AND 95% STENOSIS WAS OBSERVED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND TWO SEQUENTIAL 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). A 2.5X13MM CYPHER WAS IMPLANTED IN THE LAD AND THE RCA WAS TREATED WITH 2 UNK CYPHEER STENTS. THE PT WAS DISCHARGED HOME THREE DAYS AFTER THE PROCEDURE. SIX DAYS LATER, THE PT WAS READMITTED WITH COMPLAINTS OF CHEST PAIN, ANGIOGRAPHY REVEALED WIDELY PT STENTS IN THE LAD AND THE RCA. SIX DAYS LATER, THE PT COMPLAINED OF CHEST PAIN AGAIN, ANGIOGRAPHY WAS PERFORMED DUE TO THE SEVERITY OF THE SYMPTOMS AND REVEALED A MYCOTIC (PERTAINING TO FUNGUS) ANEURYSM IN THE STENTED PORTION OF THE LAD AND IMMEDIATELY DISTAL TO THE STENTED SEGMENT A PERFORATION WAS OBSERVED. THE AREA WAS BALLOONED WITH A 2.5MM X 12MM MAVERICK (BOSTON SCIENTIFIC) BALLOON AT 7ATMS FOR 6 MINS. ANGIOGRAPHY CONFIRMED THE PERFORATION WAS SEALED. ECHOCARDIOGRAM REVEALED MODERATE PERI-CARDIAL EFFUSION WITH NO EVIDENCE OF TAMPONADE, WHICH DID NOT REQUIRE INTERVENTION. BLOOD CULTURES WERE POSITIVE FOR METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC THERAPY. THE PT WAS DISCHARGED TO A SKILLED NURSING FACILITY TO CONTINUE ANTIBIOTIC TREATMENT WHERE SHE SUDDENLY DIED 2 WEEKS AFTER DISCHARGE. THE DEVICES REMAIN IMPLANTED IN THE PT AND ARE NOT AVAILABLE FOR INSPECTION. THE STERILE LOT NUMBERS ON THE IMPLANTED DEVICES IS UNK THEREFORE, A DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. THE LITERATURE REVIEWED REPORTED THREE KNOWN CASES OF PTS WITH PRESENTING WITH BACTEREMIA FOLLOWING THE IMPLANT OF A DRUG ELUTING STENT. IN ALL THREE CASES THE CAUSATIVE AGENT WAS STAPHYLOCOCCUS AUREUS. STAPH. AUREUS IS THE MOST PREVALENT CAUSE OF HOSP ACQUIRED INFECTIONS. THERE ARE MANY FACTORS THAT CAN IMPACT THE INTEGRITY OF THE STERILE FIELD NECESSARY TO PREVENT INFECTIONS DURING AN INVASIVE PROCEDURE. THERE ARE ALSO PROCEDURES THAT OCCUR PRIOR TO ADMITTANCE INTO A CATH LAB THAT CAN CAUSE INFECTIONS SUCH AS DRAWING BLOOD AND STARTING AN INTRAVENOUS LINE. ANY TIME THAT THE PROTECTIVE BARRIER OF SKIN IS COMPROMISED OR BREACHED THERE IS POTENTIAL FOR INFECTION. WITH THE LIMITED AMOUNT OF AVAILABLE INFO IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. BUT GIVEN THE RELATIVELY LOW INCIDENCE OF BACTEREMIA FOLLOWING DES IMPLANT THERE IS NOTHING TO SUGGEST THAT THERE IS A MFG ISSUE. PLEASE NOTE THAT THIS IS THE FINAL REPORT FOR THESE PRODUCTS.

    Description of Event or Problem · 1

    AN ARTICLE ENTITLED " SPONTANEOUS CORONARY ARTERY PERFORATION SECONDARY TO A SIROLIMUS-ELUTING STENT INFECTION" WAS FOUND DURING A LITERATURE SEARCH. THE PT HAD A TOTAL OF THREE CYPHER STENTS IMPLANTED DURING THE INDEX PROCEDURE: ONE IN THE MID LEFT ANTERIOR DESCENDING AND TWO IN THE RIGHT CORONARY ARTERY. THE INFO IN THE ARTICLE INDICATED THAT TWELVE DAYS AFTER THE INDEX PROCEDURE, THE PT WAS ADMITTED DUE TO RECURRENT CHEST PAIN. THE ECG WAS UNCHANGED. CORONARY ANGIOGRAPHY WAS DONE AND A MYCOTIC ANEURYSM WAS NOTED IN THE STENTED PORTION OF THE LEFT ANTERIOR DESCENDING (LAD) AND DISTALLY. A TYPE II CORONARY WAS ALSO EVIDENT. THE PERFORATION WAS TREATED BY A BALLOON ANGIOPLASTY. BLOOD CULTURES REVEALED METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PT WAS TRANSFERRED TO A SKILLED NURSING FACILITY AND EXPIRED TWO WEEKS POST-HOSPITAL DISCHARGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| H| L