BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER BX JAPAN 3.50 X 18 MM

    MDR report key: 7104784 · Received December 11, 2017

    Report

    Report Number
    9616099-2017-01676
    Event Type
    Death
    Date Received
    December 11, 2017
    Date of Event
    March 28, 2016
    Report Date
    December 11, 2017
    Manufacturer
    CORDIS CASHEL
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED, A CYPHER BX (B)(4) (3.50 X 18MM) WAS IMPLANTED DURING AN EMERGENCY PCI FOR TARGET LESIONS (RCA # 1, RCA # 2, LAD # 7) OF ACUTE MYOCARDIAL INFARCTION (ST ELEVATION TYPE). THE CYPHER CORONARY ARTERY STENT WAS PLACED IN THE TARGET LESION, RCA # 1. A NON-CORDIS CORONARY ARTERY STENT (STENT DIAMETER: 2.5 MM / STENT LENGTH 28 MM) WAS PLACED IN THE TARGET LESION (LAD # 7, INCLUDING BIFURCATION) WITH AN INFLATION PRESSURE OF 22 ATMOSPHERES (ATM). ANOTHER NON-CORDIS CORONARY ARTERY STENT (STENT DIAMETER: 2.5 MM / STENT LENGTH: 28 MM) WAS PLACED AT THE TARGET LESION (RCA # 2) WITH INFLATION PRESSURE 10 ATM. PRE- AND POST-INFLATIONS WERE PERFORMED. CONFIRMATION BY IVUS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. FOR HEART FAILURE DUE TO ACUTE MYOCARDIAL INFARCTION, A BALLOON WAS PLACED FOR IABP INSERTION. AFTER THE PROCEDURE, THE PATIENT DEVELOPED A URINARY TRACT INFECTION. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED. APPROXIMATELY ONE (1) YEAR AFTER THE PROCEDURE, THE PATIENT WAS HOSPITALIZATION DUE TO INTRACEREBRAL HEMATOMA. HEMATOMA REMOVAL SURGERY WAS PERFORMED AND THE PATIENT RECOVERED. APPROXIMATELY ONE (1) YEAR LATER, FIRST VERTEBRA LUMBAR COMPRESSION FRACTURE WAS FOUND. THE PATIENT RECOVERED; HOWEVER, DETAILS ARE UNKNOWN. APPROXIMATELY ONE (1) YEAR LATER, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. THE PATIENT RECOVERED; HOWEVER, DETAILS ARE UNKNOWN. ONE (1) YEAR LATER, APPROXIMATELY FOUR (4) YEARS AFTER THE PROCEDURE, THE PATIENT EXPIRED DUE TO SUSPECTED LATE-ONSET STENT THROMBOSIS. CAUSE OF DEATH WAS DIAGNOSED AS HEART FAILURE. STENT THROMBOSIS WAS SUSPECTED AS THE PATIENT DIED DUE TO CARDIAC PROBLEM; HOWEVER, STENT THROMBOSIS WAS NOT CONFIRMED. THE PHYSICIAN DOES NOT COMPLETELY DENY THE RELATIONSHIP WITH THE STENTS. THERE IS NO DEATH CERTIFICATE NOR AUTOPSY REPORT AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT WAS DISCARDED. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. ALTHOUGH BASED ON THE AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE, IT IS POSSIBLE THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS INCLUDING RESPONSIVENESS TO ANTIPLATELET THERAPY AND ANTICOAGULATION MAY HAVE CONTRIBUTED. THERE IS NO INDICATION THAT THE EVENTS ARE RELATED TO THE DEVICE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, A CYPHER BX (B)(4) (3.50 X 18MM) WAS IMPLANTED DURING AN EMERGENCY PCI FOR TARGET LESIONS (RCA # 1, RCA # 2, LAD # 7) OF ACUTE MYOCARDIAL INFARCTION (ST ELEVATION TYPE). THE CYPHER CORONARY ARTERY STENT WAS PLACED IN THE TARGET LESION, RCA # 1. A NON-CORDIS CORONARY ARTERY STENT (STENT DIAMETER: 2.5 MM / STENT LENGTH 28 MM) WAS PLACED IN THE TARGET LESION (LAD # 7, INCLUDING BIFURCATION) WITH AN INFLATION PRESSURE OF 22 ATMOSPHERES (ATM). ANOTHER NON-CORDIS CORONARY ARTERY STENT (STENT DIAMETER: 2.5 MM / STENT LENGTH: 28 MM) WAS PLACED AT THE TARGET LESION (RCA # 2) WITH INFLATION PRESSURE 10 ATM. PRE- AND POST-INFLATIONS WERE PERFORMED. CONFIRMATION BY IVUS WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. FOR HEART FAILURE DUE TO ACUTE MYOCARDIAL INFARCTION, A BALLOON WAS PLACED FOR IABP INSERTION. AFTER THE PROCEDURE, THE PATIENT DEVELOPED A URINARY TRACT INFECTION. ANTIBIOTICS WERE ADMINISTERED AND THE PATIENT WAS DISCHARGED. APPROXIMATELY ONE (1) YEAR AFTER THE PROCEDURE, THE PATIENT WAS HOSPITALIZATION DUE TO INTRACEREBRAL HEMATOMA. HEMATOMA REMOVAL SURGERY WAS PERFORMED AND THE PATIENT RECOVERED. APPROXIMATELY ONE (1) YEAR LATER, FIRST VERTEBRA LUMBAR COMPRESSION FRACTURE WAS FOUND. THE PATIENT RECOVERED; HOWEVER, DETAILS ARE UNKNOWN. APPROXIMATELY ONE (1) YEAR LATER, THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. THE PATIENT RECOVERED; HOWEVER, DETAILS ARE UNKNOWN. ONE (1) YEAR LATER, APPROXIMATELY FOUR (4) YEARS AFTER THE PROCEDURE, THE PATIENT EXPIRED DUE TO SUSPECTED LATE-ONSET STENT THROMBOSIS. CAUSE OF DEATH WAS DIAGNOSED AS HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884578 CYPHER BX JAPAN 3.50 X 18 MM CORONARY DRUG-ELUTING STENT NIQ CORDIS CASHEL CJS18350 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death TWO CORONARY ARTERY STENTS