BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1694480 · Received May 20, 2010

    Report

    Report Number
    3003742446-2010-00148
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    April 10, 2010
    Report Date
    April 28, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE (B) (4) STUDY INDICATED THAT A PATIENT DIED ONE DAY AFTER IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT HAD A MYOCARDIAL INFARCTION, WENT INTO CARDIAC ARREST AND PASSED AWAY AFTER UNSUCCESSFUL RESUSCITATIVE EFFORTS. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED AND A DEATH CERTIFICATE IS NOT AVAILABLE. DURING THE INDEX PROCEDURE, THE PATIENT RECEIVED A 2.5X23MM CYPHER BY DIRECT STENTING IN A 75% DE NOVO LESION IN THE MID LAD OF 15MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. ADDITIONALLY, A 3.0X33MM CYPHER WAS IMPLANTED IN A 75% DE NOVO LESION IN THE 1ST OBTUSE MARGINAL OF 25MM IN LENGTH IN A 3.0MM VESSEL DIAMETER. BOTH STENTS WERE DEPLOYED AT 10 ATMOSPHERES AND POST DILATION WAS CONDUCTED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THERE WERE NO PROCEDURAL COMPLICATIONS. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND PLAVIX. PAST MEDICAL HISTORY INCLUDED PREVIOUS PCI, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, TYPE II DIABETES MELLITUS TREATED WITH ORAL MEDICATION, SMOKING WITHIN THE LAST 30 DAYS. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND WAS EMERGENTLY HOSPITALIZED. THE PATIENT WAS DIAGNOSED WITH AN ACUTE STEMI AND WENT INTO CARDIAC ARREST. THE PATIENT WAS INTUBATED AND ACLS MEDICATIONS WERE GIVEN PER PROTOCOL BUT RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CYPHER STENTS AND THE PATIENT¿S DEATH. HOWEVER, THERE ARE RISK FACTORS IN THE PATIENT¿S MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00147 AND 3003742446-2010-00148.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DATE OF MYOCARDIAL INFARCTION WAS CHANGED TO (B)(6) 2012 FROM (B)(6) 2012, BASED ON THE (B)(6). THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00147 AND 3003742446-2010-00148.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE INITIAL REPORT SHOULD HAVE INDICATED A CARDIAC ARREST, PER THE REPORT RECEIVED FROM THE SITE. THEREFORE, THIS REPORT IS INTENDED TO COREST THE OMISSION AND THE CODE IS NOTED. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT DIED (B)(6) AFTER IMPLANTATION OF TWO CYPHER STENTS DUE TO MYOCARDIAL INFARCTION. THE STUDY SITE REPORTED THAT THE PATIENT WAS ADMITTED WITH MYOCARDIAL INFARCTION, WENT INTO CARDIAC ARREST AND PASSED AWAY AFTER UNSUCCESSFUL RESUSCITATIVE EFFORTS. ADJUDICATION MINUTES RECEIVED INDICATED THAT THE CAUSE OF DEATH WAS CARDIAC DUE TO AN ACUTE MYOCARDIAL INFARCTION. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED. DURING THE INDEX PROCEDURE, THE PATIENT RECEIVED A 2.5X23 MM CYPHER BY DIRECT STENTING IN A 75% DE NOVO LESION IN THE MID LAD OF 15 MM IN LENGTH IN A 2.5 MM VESSEL DIAMETER. ADDITIONALLY, A 3.0X33 MM CYPHER WAS IMPLANTED IN A 75% DE NOVO LESION IN THE 1ST OBTUSE MARGINAL OF 25 MM IN LENGTH IN A 3.0 MM VESSEL DIAMETER. BOTH STENTS WERE DEPLOYED AT 10 ATMOSPHERES AND POST DILATION WAS CONDUCTED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THERE WERE NO PROCEDURAL COMPLICATIONS. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND PLAVIX. PAST MEDICAL HISTORY INCLUDED PREVIOUS PCI, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, TYPE II DIABETES MELLITUS TREATED WITH ORAL MEDICATION, SMOKING WITHIN THE LAST 30 DAYS. THE DAY AFTER THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND WAS EMERGENTLY HOSPITALIZED. THE PATIENT WAS DIAGNOSED WITH AN ACUTE STEMI AND WENT INTO CARDIAC ARREST. THE PATIENT WAS INTUBATED AND ACLS MEDICATIONS WERE GIVEN PER PROTOCOL BUT RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL INFARCTION MAY LEAD TO CARDIAC ARREST AND SUBSEQUENT DEATH. DEATH IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CYPHER STENTS AND THE PATIENT'S DEATH. HOWEVER, THERE ARE RISK FACTORS IN THE PATIENT'S MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00147 AND 3003742446-2010-00148.

    Additional Manufacturer Narrative · 1

    THE (B1) LESION WAS B1 WITHOUT HEAVY CALCIFICATION AND VESSEL TORTUOSITY. THE LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT 8 ATM BEFORE A 3.0X33MM CYPHER RX STENT WAS DEPLOYED AT 10 ATM. POST-DILATATION WAS PERFORMED WITH A 2.5X15MM BALLOON AT 12 ATM DUE TO SUB-OPTIMAL RESULTS AND AS A STANDARD PRACTICE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THERE WERE NO PROCEDURAL COMPLICATIONS. CONCOMITANT MEDICATIONS (PRE-PROCEDURE): ASPIRIN, PLAVIX. INTRA-PROCEDURE MEDICATIONS ((B) (6) 2010): BIVALIRUDIN (ANGIOMAX). POST-PROCEDURE ((B) (6) 2010): ASPIRIN AND PLAVIX. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2010-00147 AND 3003742446-2010-00148.

    Description of Event or Problem · 1

    POSEY RECEIVED A MEDWATCH REPORT FROM THE FDA THAT A USER FACILITY REPORTED THAT A (B) (6) MALE PATIENT WAS IN BED USING 8307 SENSOR PAD AND A 8374 ALARM. THE BED ALARM SOUNDED FREQUENTLY DURING THE NIGHT. EACH TIME THE NURSE ENTERED THE ROOM, RESET THE ALARM, CHECKED THE CONNECTIONS AND BED PAD PLACEMENT. MONITORING CARE WAS PROVIDED AND THE NURSE LEFT THE ROOM. THE STAFF WAS IMMEDIATELY NOTIFIED THAT THE PATIENT WAS ON THE FLOOR, BED ALARM DID NOT SOUND. MORE INFORMATION RECEIVED WAS THE PATIENT HAD A BROKEN HIP AND SURGERY. THE STAFF DETERMINED THAT THE PAD HAS A BROKEN RED WIRE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B) (4) STUDY INDICATED THAT A PATIENT DIED TWO DAYS AFTER PCI WAS PERFORMED. THE PATIENT HAD BEEN DISCHARGED AFTER THE PCI PROCEDURE AND WAS HOSPITALIZED IN A DIFFERENT HOSPITAL. THE PATIENT HAD A MYOCARDIAL INFARCTION AND SUBSEQUENTLY DIED. IT WAS CONSIDERED A CARDIAC DEATH. IT IS NOT KNOWN IF AN AUTOPSY WAS PERFORMED AND A DEATH CERTIFICATE IS NOT AVAILABLE. THE PRIMARY CAUSE OF DEATH IS ALSO NOT KNOWN. PCI WAS FIRST PERFORMED ON A 75% DE NOVO LESION IN THE MID LAD OF 15MM IN LENGTH IN A 2.5MM VESSEL DIAMETER. THE LESION WAS CHARACTERIZED AS B1 WITHOUT HEAVY CALCIFICATION AND VESSEL TORTUOSITY. A 2.5X23MM CYPHER RX WAS DEPLOYED AT 10 ATM BY DIRECT STENTING. POST-DILATATION WAS PERFORMED WITH A 2.5X15MM BALLOON AT 12 ATM DUE TO SUB-OPTIMAL RESULTS AND AS A STANDARD PRACTICE. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOW WAS RECORDED PRE AND POST-PROCEDURE, RESPECTIVELY. PCI WAS PERFORMED NEXT ON A 75% DE NOVO LESION IN THE 1ST OBTUSE MARGINAL OF 25MM IN LENGTH IN A 3.0MM VESSEL DIAMETER.

    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) 15107361

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death| H| L