BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 2122999 · Received June 14, 2011

    Report

    Report Number
    1016427-2011-00052
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 19, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE NUMBER OF STENTS IMPLANTED DURING EACH PROCEDURE REPORTED IS UNKNOWN, IT IS ASSUMED 4 PALMAZ SCHATZ CORONARY STENTS WERE IMPLANTED IN 1995. THE PATIENT HAD RESTENOSIS AND A MI IN 1997, WITH 4 MORE PALMAZ SCHATZ CORONARY STENTS IMPLANTED. IN 2000, THE PATIENT HAD ANOTHER RESTENOSIS WITH A BYPASS AND 4 MORE STENTS IMPLANTED. THESE STENTS WERE CONSIDERED TO BE BX VELOCITY STENTS. IN 2002, THE PATIENT HAD 4 BX SONIC STENTS IMPLANTED TO TREAT ANOTHER RESTENOSIS. IN 2010, THE PATIENT HAD 2 CYPHER STENTS IMPLANTED TO TREAT THE RESTENOSIS OF 2 OF THE PREVIOUSLY IMPLANTED BX SONIC STENTS. THIS IS ONE OF 14 PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2011-00047, 1016427-2011-00048, 1016427-2011-00049, 1016427-2011-00050, 1016427-2011-00051, 1016427-2011-00052, 1016427-2011-00053, 1016427-2011-00054, 1016427-2011-00055, 1016427-2011-00056, 1016427-2011-00057, 1016427-2011-00058, 1016427-2011-00059, AND 1016427-2011-00060. THE STERILE LOT NUMBERS FOR THE DEVICES ARE UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. THE ACT OF IMPLANTING CORONARY ARTERY STENTS IS TO OPEN UP A BLOCKED ARTERY AND RESTORE BLOOD FLOW DISTAL TO THE LESION, THE DEVICE IS NOT MEANT TO PREVENT NEW DISEASE FROM FORMING. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED INFORMATION DOES NOT LEND TO A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    A FAMILY MEMBER CALLED ON BEHALF OF A CONSUMER INITIALLY FOR MEDICAL INFORMATION AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON 1995-U-U, AN UNKNOWN AMOUNT OF "UNSPECIFIED CORDIS STENTS" WERE PLACED IN UNKNOWN VESSELS AS TREATMENT FOR A "HEART ATTACK." ON U-U-U, CONSUMER'S "STENTS OCCLUDED" WHICH LED TO A "HEART ATTACK" ON 1997-U-U. AS TREATMENT, CONSUMER WAS HOSPITALIZED AND "MORE UNSPECIFIED CORDIS STENTS WERE PLACED" IN UNKNOWN VESSELS ON 1997-U-U. ON U-U-U, CONSUMER EXPERIENCED "CHEST PAIN" WHICH LED TO HOSPITALIZATION. FURTHER UNSPECIFIED TESTING SHOWED THAT THE "STENTS OCCLUDED AGAIN." AS TREATMENT, A TRIPLE BYPASS WAS PERFORMED AND AN UNKNOWN AMOUNT OF "UNSPECIFIED CORDIS STENTS" WERE PLACED IN UNKNOWN VESSELS ON 2000-U-U. DURING HOSPITALIZATION, ON 2000-U-U CONSUMER EXPERIENCED AN UNKNOWN EVENT WHICH LED TO AN "INCORRECT INTUBATION" CAUSING CONSUMER TO HAVE A "PERMANENT TRACH."ADDITIONALLY, ON 2000-U-U, CONSUMER EXPERIENCED "THORACIC HERNIATED DISCS." NO TREATMENT WAS REPORTED FOR THIS ONGOING EVENT. ON U-U-U, CONSUMER EXPERIENCED "KIDNEY FAILURE" FURTHER DESCRIBED AS "STAGE 3" AND WAS HOSPITALIZED AS TREATMENT. NO FURTHER TREATMENT WAS REPORTED FOR THIS ONGOING EVENT. ON 2002-U-U, AN UNKNOWN AMOUNT OF "UNSPECIFIED CORDIS STENTS" WERE PLACED IN UNKNOWN VESSELS FOR UNKNOWN REASONS. ON (B)(6) 2010, TWO CYPHER STENTS WERE PLACED IN UNKNOWN VESSELS FOR UNKNOWN REASONS. THE FAMILY MEMBER OF THE CONSUMER STATED, "ALL IN ALL HE HAS HAD 42 CATHS AND ANGIOPLASTIES, 18 UNSPECIFIED CORDIS STENTS PLACED, AND PUT ON MANY UNSPECIFIED HEART AND BLOOD PRESSURE MEDICATIONS FOR UNKNOWN REASONS ON U-U-U. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM CORONARY SDS/STENTS (MAF) MAF CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R