BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 381163 · Received March 7, 2002

    Report

    Report Number
    2939520-2002-00003
    Event Type
    Death
    Date Received
    March 7, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 7, 2002
    Manufacturer
    JOMED GMBH
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO DAYS PRIOR TO THE EVENT, PT WAS ELECTIVELY ADMITTED FOR PLANNED INTERVENTION IN THE CATH LAB AFTER 2 CONSULTS TO DIFFERENT CARDIOVASCULAR SURGEONS WERE OBTAINED. PT WAS FELT TO BE TOO HIGH OF A RISK FOR A 3RD CABG. A SUCCESSFUL PTCA/STENT PROCEDURE WAS PERFORMED IN THE LEFT INTERNAL MAMMARY ARTERY TO THE LEFT ANTERIOR DESCENDING NEAR THE ANASTAMOSIS. ROTOBLATOR WAS THEN PERFORMED IN THE CIRCUMFLEX ARTERY AND LEFT MAIN. FOLLOWING THIS, IT WAS NOTED THAT PATIENT HAD A PERFORATION OF THE CIRCUMFLEX ARTERY WITH FREE EXTRAVASATION OF CONTRAST INTO THE PERICARDIUM, WITHOUT EVIDENCE OF PERICARDIAL TAMPONADE. MULTIPLE INFLATIONS WITH A BALLOON WERE UNABLE TO RESOLVE THE PERFORATION, AND THE ANGIOMAD (BLOOD THINNER) GIVEN WAS UNABLE TO BE REVERSED FOR FEAR OF THROMBOSING THE FRESHLY PLACED STENT IN THE LEFT INTERNAL MAMMARY ARTERY. A JOMED JOSTENT WAS THEN CHOSEN TO BE PLACED IN THE CIRCUMFLEX ARTERY. IT WOULD NOT ADVANCE BEYOND THE PROXIMAL PORTION OF THE CIRCUMFLEX AND SO WAS DEPLOYED IN THE LEFT MAIN IN A SUCCESSFUL ATTEMPT TO COMPLETELY OCCLUDE THE LEFT MAIN CIRCUMFLEX AREA AND SEAL OFF THE PERFORATION. THE PT WAS THEN TRANSFERRED TO THE ICU IN A STABLE CONDITION. THE PROCEDURE WAS DISCUSSED IN GREAT DETAIL TO BOTH THE PT AND THE PT'S SPOUSE AT THAT TIME. POST-PROCEDURAL COMPLICATIONS INCLUDED CONGESTIVE HEART FAILURE AND PULMONARY EDEMA. TWO DAYS PRIOR TO THE EVENT AT APPROX 22:16, THE PT ALLEGEDLY HAD AN EPISODE OF VENTRICULAR TACHYCARDIA AND WAS UNRESPONSIVE. A CODE WAS CALLED AND UPON ARRIVAL OF THE RESPONDING PHYSICIAN, PT HAD RETURNED SPONTANEOUSLY TO SINUS RHYTHM AND WAS SUCCESSFULLY RESUSCITATED. PT WAS SEEN IN CONSULT BY A GI PHYSICIAN THE NEXT DAY FOR A COMPLAINT OF ABDOMINAL FULLNESS AND DIAGNOSED WITH A HEPATOMEGALLY/RULE OUT PANCREATIC MASS. ON THE DAY OF THE EVENT AT APPROX 11:48 AM (AFTER A SHEATH WAS PULLED FROM PT'S LEFT GROIN), THE PT AGAIN CODED AND THIS TIME RESUSCITATION WAS UNSUCCESSFUL. AN AUTOPSY WAS PERFORMED THIS MORNING. THIS CONFIRMED THE PLACEMENT OF THE JOMED JOSTENT WITH A VERY LIMITED AREA OF HEMATOMA IN A LOCULATED BASILAR SEGMENT WITHOUT EVIDENCE OF PERI-EFFUSION. THUS, THE JOMED JOSTENT WAS PERFORMED AS REQUIRED FOR THE CLOSURE OF A PERFORATION AND WAS NOT FELT TO BE A DIRECT CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT CORONARY STENT GRAFT DSY JOMED GMBH 010CG12UA 052357

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death