BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1626119 · Received March 5, 2010

    Report

    Report Number
    1219856-2010-00119
    Event Type
    Death
    Date Received
    March 5, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 5, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B) (6) 2010, PT WAS ADMITTED TO THE 1ST DEPARTMENT OF CARDIOLOGY. PRIOR TO THIS, HE WAS EXPERIENCING SEVERE CHEST PAIN, THE ONSET OF THESE SYMPTOMS WAS 1.5 HOURS EARLIER THIS DAY. ON ADMISSION, PT WAS IN "BAD CONDITION." TACHYCARDIA, SOME CRACKLES AT THE BOTTOM OF THE LUNGS, BLOOD PRESSURE 70/50MMHG. AS A RESULT, PT WAS IMMEDIATELY TRANSPORTED TO CATH LAB AND CORONARY ANGIOGRAPHY WAS PERFORMED. IT REVEALED SEVERE NARROWING OF LMN (70%), OCCLUSION OF LEFT ANTERIOR DESCENDING (LAD) AND LCX WITH NON OBSTRUCTED BYPASS TO RIGHT CORONARY ARTERY (RCA) AND LIMA TO LAD. DUE TO PT'S DROP OF BLOOD PRESSURE, PHYSICIAN INSERTED AN INTRA-AORTIC BALLOON (IAB) THROUGH A SHEATH INTO THE LEFT FEMORAL ARTERY. THE BLOOD PRESSURE INCREASED TO 100/70MMHG AND PHYSICIAN PERFORMED ANGIOPLASTY OF LMN AND LAD WITH IMPLANTATION OF DES AND BMS RESPECTIVELY. AFTER PROCEDURE, IMPROVEMENT OF PT'S STATE OCCURRED (BP110/70MMHG, LOSS OF PAIN PROPER "DIURESIS"). HOWEVER, THE NEXT DAY ((B) (6) 2010), THERE WAS AN INCREASE IN PULMONARY CONGESTION AND ARRHYTHMIA APPEARED; RAPID ATRIAL FIBRILLATION WHICH CONVERTED SPONTANEOUSLY INTO SINUS RHYTHM. "WE MODIFIED DOSES OF DRUGS AND OBTAINED SMALL TEMPORARY IMPROVEMENT." AT 13:45 HOURS, PT LOST CONSCIOUSNESS, NO PULSE ON CAROTID ARTERY WITH PRESERVED SINUS RHYTHM 120/MIN; LOSS OF SATURATION, SHORT INDIRECT CARDIAC MASSAGE WAS PERFORMED. "WE OBSERVED BLOOD IN BALLOON LINE." IAB WAS REMOVED (WE NOTICED A RUPTURE ALONG THE BALLOON), ANOTHER IAB WAS IMMEDIATELY INSERTED; POSITION WAS CHECKED IN CATH LAB. AFTER THREE HOURS, HE PRESENTED WITH SEVERE ARRHYTHMIA. PT DID NOT RESPOND TO TREATMENT AND DIED. AUTOPSY REVEALED SEVERE MYOCARDIAL INFARCTION AND GENERAL ATHEROSCLEROSIS. "ANY FEATURES OF AORTA INJURY WERE OBSERVED." "IN OUR OPINION, PT'S LOSS OF CONSCIOUSNESS WAS CONNECTED WITH THE IAB DYSFUNCTION. DUE TO THE PAUSE IN MECHANICAL SUPPORT OF THE LEFT VENTRICLE FUNCTION, FURTHER DETERIORATION IN PT'S CLINICAL STATUS OCCURRED RESULTING IN THE PT'S DEATH." THERE ARE NOT PUMP STRIPS. X-RAYS WERE PERFORMED. FLUOROSCOPY DURING INSERTION ON (B) (6) 2010 AND AFTER INSERTION OF THE SECOND IAB ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death DOPAMINE| UNFRACTIONATED HEPARIN| DOBUTAMINE| ASPIRIN| CLOPIDOGRELUM