BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040538 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01267
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 5, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS MEDWATCH REFLECTS ONE OF TWO PRODS ASSOCIATED WITH THIS ADVERSE EVENTS. THE MFG REPORT #'S ARE: 9616099-2008-01265 & -01267. THESE CYPHER SIROLIMUS-ELUTING CORONARY STENTS ARE DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, THEY ARE SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENTS. THIS FEMALE IN THE REGISTRY EXPERIENCED ELEVATED CARDIAC ENZYMES POST IMPLANTATION OF 2 CYPHER STENTS. MEDICAL HISTORY INCLUDED KNOWN CORONARY DISEASE WITH PRIOR MI AND PCI, HYPERTENSION AND DIABETES. THE INDEX PROCEDURE WAS DONE IN THE SETTING OF UNSTABLE ANGINA; PRE-PROCEDURE CK-MB AND TROPONIN WERE NORMAL. ASA, PLAVIX, LOW MOLECULAR WEIGHT HEPARIN AND AGGRASTAT WERE GIVEN FOR THE PROCEDURE. THE PROXIMAL LAD WAS DESCRIBED AS TYPE B2: IRREGULAR, 100% STENOSIS WITH 16 MM LESION LENGTH. A 3.5/18 MM CYPHER SELECT PLUS STENT WAS IMPLANTED DIRECTLY. THERE WAS NO RESIDUAL STENOSIS, TIMI III FLOW WAS RESTORED AND THE END RESULT WAS "SATISFACTORY". EFFORTS WERE THEN TURNED TO A LESION IN THE MID-LAD, WHICH WAS ALSO DESCRIBED AS TYPE B2: IRREGULAR WITH 90% STENOSIS AND 12MM LESION LENGTH. A 2.75/13MM CYPHER SELECT PLUS WAS IMPLANTED DIRECTLY. THERE WAS NO RESIDUAL STENOSIS. TIMI III FLOW WAS RESTORED AND THE END RESULT WAS "SATISFACTORY". NO COMPLICATIONS WERE REPORTED; HOWEVER, POST-PROCEDURE CK-MB AND TROPONIN WERE BOTH 4X ABOVE THE UNL. THE PT WAS DISCHARGED ON ASA AND PLAVIX. AT THE 1-MONTH F/U, THE PT'S ANGINAL STATUS WAS POSITIVE. APPROXIMATELY, 2 MONTHS LATER, HE WAS RE-ADMITTED FOR TREATMENT OF A CIRCUMFLEX LESION; THIS WAS SUCCESSFUL. NEITHER STENT WAS RETURNED FOR EVAL; THEY REMAINED IMPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW. REVIEW OF THE AVAILABLE INFO INDICATES THAT THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    DURING THE ONE MONTH F/U, THE PT EXPERIENCED ANGINA PECTORIS. THE MEDICATION TREATMENT OF ASPIRIN, STATINS ACE INHIBITORS, ORAL ANTIDIABETICS, BETA-BLOCKERS AND CLOPIDOGREL WAS ON GOING. THREE MONTHS POST INDEX PROCEDURE, THE PT UNDERWENT A STAGED PROCEDURE TO TREAT A 75% STENOSED PROXIMAL CIRCUMFLEX. POST-PROCEDURE DIAMETER STENOSIS WAS 0%. THIS PT WAS ENROLLED IN THE STUDY IN 2007 WITH 2-VESSEL DISEASE. THE MAIN INDICATION FOR THIS INTERVENTION WAS UNSTABLE ANGINA PECTORIS. THE PT'S HEART RATE AT THE BEGINNING OF THE PROCEDURE WAS 68 BEATS/MIN AND THE BLOOD PRESSURE WAS 130/70 MMHG. THE FIRST TARGET LESION WAS A NATIVE, DE NOVO, NON-OSTIAL, IRREGULAR, READILY ACCESSABLE, CONCENTRIC, TYPE B2 PROXIMAL LEFT ANTERIOR DESCENDING. THE REFERENCE VESSEL DIAMETER WAS 3.5 MM AND THE LESION LENGTH WAS 16 MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 100%. THE LESION WAS DIRECT STENTED WITH A 3.5 X 18 MM CYPHER SELECT PLUS STENT, WHICH WAS ELECTIVELY IMPLANTED AT 15 ATM WITH SATISFACTORY RESULTS. THE STENT WAS NOT POST DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS 0%. THE SECOND TARGET LESION WAS A NATIVE, DE NOVO, NON-OSTIAL, IRREGULAR, READILY ACCESSIBLE, ECCENTRIC, TYPE B2 MID LEFT ANTERIOR DESCENDING. THE REFERENCE VESSEL DIAMETER WAS 3 MM AND THE LESION LENGTH WAS 12 MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 90%. THE LESION WAS DIRECT STENTED WITH A 2.75 X 13 MM CYPHER SELECT PLUS STENT, WHICH WAS ELECTIVELY IMPLANTED AT 15 ATM WITH SATISFACTORY RESULTS. THE STENT WAS NOT POST-DILATED. POST PROCEDURE DIAMETER STENOSIS WAS 0%. THE PT'S PRE-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, ACE INHIBITORS, AND BETA-BLOCKERS. THE PT'S INTRA PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, AGGRASTAT, HEPARIN AND CLOPIDOGREL. THE PT'S POST-PROCEDURE MEDICATION INCLUDED ASPIRIN, STATINS, ACE INHIBITORS, ORAL ANTIDIABETICS, BETA-BLOCKERS AND CLOPIDOGREL.

    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 13286018

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening A 6 FR CATHETER WAS USED DURING THE PROCEDURE