BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2120433 · Received June 10, 2011

    Report

    Report Number
    9616099-2011-00408
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    January 20, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDEX PROCEDURE WAS AN ELECTIVE CASE. THE TARGET LESION WAS THE RPD. THE LESION WAS REPORTED TO BE: DE NOVO, A 90% STENOSIS, 28 MM LENGTH, 2.5 MM VESSEL DIAMETER, CONCENTRIC, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.25 X 15 MM BALLOON CATHETER AT 6 ATM. FOR 30 SECONDS. A CYPHER 2.5 X 18 MM STENT WAS IMPLANTED AT 8 ATM. FOR 20 SECONDS. A TAXUS 2.75 X 12 MM STENT WAS IMPLANTED PROXIMAL TO THE CYPHER STENT IN OVERLAPPING FASHION. THE PHYSICIAN USED THE TAXUS BALLOON CATHETER TO POST-DILATE THE LESION. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS 0% AND THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. AN ACT WAS NOT MEASURED. APPROXIMATELY THREE AND ONE-HALF MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD AN ADDITIONAL PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS THE FIRST DIAGONAL BRANCH. THE TARGET LESION WAS REPORTED TO BE: A BIFURCATION LESION. NO ADDITIONAL PROCEDURAL OR TARGET LESION DETAILS WERE AVAILABLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A PATIENT EXPERIENCED AN ACUTE MYOCARDIAL INFARCTION (AMI) DUE TO THROMBUS APPROXIMATELY TWO YEARS POST IMPLANTATION OF A CYPHER STENT AT A BIFURCATED LESION. THE PATIENT'S MEDICAL HISTORY INCLUDES: ISCHEMIC CARDIAC DISEASE, HYPERTENSION AND DIABETES. THE PATIENT ORIGINALLY HAD A CYPHER 2.5 X 18 MM STENT IMPLANTED IN THE RIGHT POSTERIOR DESCENDING (RPD) BRANCH TARGET LESION DURING THE ELECTIVE INDEX PROCEDURE ALONG WITH AN OVERLAPPING TAXUS 2.75 X 12 MM STENT. APPROXIMATELY THREE AND ONE-HALF MONTHS LATER, THE PATIENT HAD ANOTHER UNKNOWN CYPHER STENT (CYPHER STENT #2) IMPLANTED IN THE FIRST DIAGONAL BRANCH TARGET LESION. THE LESION LENGTH AND VESSEL DIAMETER WERE UNKNOWN. THE (B)(4) IFU CONTRAINDICATES THE USE OF THIS PRODUCT ON THE FOLLOWING LESIONS: THE LEFT MAIN TRUNK, OR OSTIUM OR LESIONS IN THE BIFURCATION AREA. IT WAS UNKNOWN IF PRE-DILATION WAS CONDUCTED. TIMI FLOWS BEFORE AND AFTER, AND PRE-PROCEDURE AND RESIDUAL STENOSIS WERE ALSO UNKNOWN. APPROXIMATELY TWO YEARS AND FIVE MONTHS AFTER THE IMPLANTATION OF THE CYPHER STENT IN THE FIRST DIAGONAL BRANCH, THE PATIENT COMPLAINED OF CHEST PAIN AND WAS EMERGENTLY HOSPITALIZED. THE PATIENT WAS DIAGNOSED WITH AMI. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED INSIDE THE 2ND CYPHER AT THE PROXIMAL END, AND THE MID LAD. THE 2ND CYPHER IMPLANTED IN THE FIRST DIAGONAL BRANCH WAS PROTRUDING A LITTLE OUT (LESS THAN 1MM) INTO THE MID LAD. TO TREAT THE THROMBUS, ASPIRATION WAS CONDUCTED IN THE MID LAD AND POBA WERE CONDUCTED. AND THEN A NON-CORDIS STENT (ENDEAVOR SP 3.5/18MM) WAS IMPLANTED AT 12ATM FOR 30SECONDS AND A KISSING BALLOON TECHNIQUE (KBT) WAS CONDUCTED WITH A BALLOON (2.5/15MM) AT 12ATM FOR 30SECONDS AND WITH A BALLOON (3.5/10MM) 18ATM FOR 30SECONDS AT LAD AND FIRST DIAGONAL. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER ADMISSION. ADDITIONAL INFORMATION WAS NOT AVAILABLE. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND TICLOPIDINE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. DISCONTINUATION OF ANTIPLATELET THERAPY MAY CAUSE THROMBUS FORMATION. THROMBUS FORMATION DECREASES THE AMOUNT OF BLOOD FLOW TO THE CARDIAC MUSCLE INDUCING AN MI. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR THROMBOTIC EVENTS INCLUDE THOSE WITH LONG LESIONS, A VESSEL DIAMETER LESS THAN 3MM AND PREVIOUS THROMBUS. THE PHYSICIAN COMMENTED THAT "THE PROBABLE CAUSE OF THE THROMBOTIC EVENT AT THE MID LAD/DIAGONAL BRANCH WAS BECAUSE OF THE STENT PROTRUDING INTO THE MID LAD." COMMON TECHNIQUES DURING INTERVENTION OF BIFURCATION LESIONS INCLUDE DOUBLE GUIDE WIRE TECHNIQUE AND KISSING-BALLOON INFLATION. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE POSSIBLE PATIENT FACTORS (DIABETES AND HYPERTENSION), VESSEL CHARACTERISTICS (BIFURCATION) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT HAD A CYPHER 2.5 X 18 MM STENT IMPLANTED IN THE RIGHT POSTERIOR DESCENDING (RPD) BRANCH TARGET LESION DURING THE ELECTIVE INDEX PROCEDURE ALONG WITH AN OVERLAPPING TAXUS 2.75 X 12 MM STENT. APPROXIMATELY THREE AND ONE-HALF MONTHS LATER, THE PATIENT HAD ANOTHER UNKNOWN CYPHER STENT (CYPHER STENT #2) IMPLANTED IN THE FIRST DIAGONAL BRANCH TARGET LESION. APPROXIMATELY TWENTY-THREE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND WAS ADMITTED EMERGENTLY TO ANOTHER HOSPITAL. THE PATIENT WAS DIAGNOSED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI). CORONARY ANGIOGRAPHY WAS DONE AND THROMBUS WAS OBSERVED INSIDE THE PROXIMAL PORTION OF THE SECOND CYPHER STENT IMPLANTED IN THE FIRST DIAGONAL LESION. THE CYPHER STENT WAS ALSO OBSERVED TO BE PROTRUDING OUT A LITTLE LESS THAN ONE MM (1 MM.) INTO THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE VERY LATE THROMBOSIS WAS TREATED BY ASPIRATION AND BALLOON ANGIOPLASTY ONLY (POBA). AN ENDEAVOR SP 3.5 X 18 MM STENT IMPLANTED AT 12 ATM FOR 30 SECONDS. A KISSING BALLOON TECHNIQUE (KBT) WAS DONE USING A 2.5 X 15 MM BALLOON AT 12 ATM FOR 30 SECONDS AND A 3.5 X 10 MM BALLOON AT 18 ATM FOR 30 SECONDS IN THE MID LAD/FIRST DIAGONAL. THE PATIENT WAS DISCHARGED EIGHT DAYS AFTER ADMISSION. THE PHYSICIAN'S COMMENT WAS THAT THE PROBABLE CAUSE OF THE THROMBOTIC EVENT AT THE MID LAD/DIAGONAL BRANCH WAS BECAUSE OF THE STENT PROTRUDING INTO THE MID LAD.

    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 63 YR Hospitalization| L| R