BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1220482 · Received November 4, 2008

    Report

    Report Number
    3003742446-2008-00252
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    May 23, 2008
    Report Date
    August 27, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INFO RECEIVED FROM THE PATIENT'S WIFE AND PHYSICIAN INDICATED THAT THE PATIENT EXPERIENCED A SIDE BRANCH OCCLUSION MYOCARDIAL INFARCTION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR CHRONIC ISCHEMIC HEART DISEASE, HYPERTENSION, HYPERLIPIDEMIA AND RHEUMATOID ARTHRITIS. THE INDICATION FOR THE PROCEDURE WAS AN ACUTE INFERIOR WALL MI WITH THROMBUS PRESENT. ANGIOGRAPHY WAS PERFORMED REVEALING A 95% PROXIMAL STENOSIS IN THE RIGHT CORONARY ARTERY (RCA) WITH THROMBUS PRESENT, AN 80% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), A 70% STENOSIS IN THE MID LAD, AN 80% OSTIAL LESION IN THE FIRST DIAGONAL (DX) COMING OFF THE PROXIMAL LAD AND 40-50% STENOSIS IN THE MID CIRCUMFLEX ARTERY. THE RCA WAS DIRECT STENTED WITH A 3.5MM X 18MM CYPHER STENT WITH GOOD ANGIOGRAPHIC RESULTS. A STAGED PROCEDURE WAS PLANNED FOR TREATMENT OF THE LAD THREE WEEKS LATER. THE PROXIMAL LAD WAS PRE-DILATED WITH A 3.0MM X 15MM BALLOON FOLLOWED BY THE DEPLOYMENT OF A 3.5MM X 23MM CYPHER STENT. A 3.5MM X 28MM CYPHER STENT WAS THEN DEPLOYED IN THE PROXIMAL TO MID LAD OVERLAPPING THE FIRST STENT WITH GOOD ANGIOGRAPHIC RESULTS SHOWING 0% RESIDUAL STENOSIS. "THERE WAS OCCLUSION OF THE SMALL FIRST DX BRANCH THAT WAS LATE FILLING. THIS WAS TOO SMALL FOR PERCUTANEOUS INTERVENTION". THE PATIENT WAS MONITORED OVERNIGHT AND DISCHARGED THE FOLLOWING DAY. SIX DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF WORSENING AND CHANGING CHEST PAIN, TROPONINS WERE NOTED TO BE ELEVATED. THE EVENT WAS DIAGNOSED AS A NON-ST SEGMENT ELEVATED MYOCARDIAL INFARCTION, DUE TO THE SIDE BRANCH OCCLUSION OF THE FIRST DX. PER THE PHYSICIANS NOTES "THIS WAS ACTUALLY AN EXPECTED EVENT FROM HIS PROCEDURE. THE PATIENT WAS MONITORED OVERNIGHT AND DISCHARGED THE FOLLOW DAY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THE STERILE LOT NUMBERS FOR THE STENTS IS UNKNOWN, THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. AS PER THE INSTRUCTIONS FOR USE (IFU), IMPLANTING A STENT MAY COMPROMISE SIDE BRANCH PATENCY. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS IMPLANTED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBER 3003742446-2008-00179.

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO THE CATH LAB IN AN EMERGENT FASHION. THE RIGHT CORONARY ARTERY (RCA) WAS A LARGE CALIBER, DOMINANT VESSEL. IT HAD A 95% PROXIMAL STENOSIS WITH THROMBUS. THE RCA WAS TREATED WITH A 3.5 X 18MM CYPHER STENT. A STAGED PROCEDURE WAS PERFORMED AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD AN 80% PROXIMAL STENOSIS. THIS WAS FOLLOWED BY A 70% MID VESSEL STENOSIS. THERE WAS A SMALL FIRST DIAGONAL BRANCH WITH 80% OSTIAL STENOSIS. THE PROXIMAL LAD WAS PRE-DILATED WITH A 3.0 X 15MM MAVERICK BALLOON WAS ADVANCED TO THE PROXIMAL LAD. THEN, A 3.5 X 23MM CYPHER STENT WAS DEPLOYED AT 14 ATM FOR 20 SECS. A 3.5 X 28MM CYPHER STENT WAS IMPLANTED AT 14 ATM FOR 20 SECS OVERLAPPING THE FIRST STENT. THE OVERLAPPING SITE WAS POST- DILATED WITH THE 2ND STENT'S BALLOON AT 14 AMT FOR 10 SECS. THERE WAS 0% RESIDUAL STENOSIS IN THE PROXIMAL AND MID LAD. THERE WAS OCCLUSION OF THE SMALL FIRST DIAGONAL BRANCH THAT WAS FILLING LATE. THIS WAS TOO SMALL FOR PERCUTANEOUS INTERVENTION. FIVE DAYS LATER, THE PATIENT PRESENTED WITH CHEST DISCOMFORT. HE STATED THAT IT WAS ACTUALLY MUCH WORSE THAN WHAT HE HAD BEEN EXPERIENCING AT THE TIME OF HIS PRIOR DISCHARGE AND HE WENT BACK TO THE EMERGENCY ROOM. HE DID HAVE A SMALL ENZYME LEAK AND IT WAS PRESUMED THAT HE HAD LIKELY CLOSED THE FIRST DIAGONAL BRANCH. ONCE HIS PAIN WAS RESOLVED, HE STATES HE HAS NO FURTHER EPISODES OF CHEST DISCOMFORT SINCE HIS MOST RECENT DISCHARGE. THE PATIENT STOPPED TAKING IMDUR SINCE HIS LAST DISCHARGE AND HAS HAD NO FURTHER CHEST DISCOMFORT. HE DENIES ANY UNUSUAL SHORTNESS OF BREATH. HE HAS HAD NO PAROXYSMAL NOCTURNAL DYSPNEA, ORTHOPNEA, PALPITATIONS OR LOWER EXTREMITY EDEMA. HE DID NOT HAVE ANY GROIN SITE ACCESS COMPLICATIONS.

    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 58 YR Hospitalization 3.0 X 15MM MAVERICK BALLOON