BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 3092496 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02762
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED MYOCARDIAL INFARCTION, DEATH, HYPOTENSION, AND THROMBOSIS ARE LISTED IN INSTRUCTIONS FOR USE (IFU), AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. COMBINATION USE OF A TANDEMHEART WITH AN EXTRACORPOREAL OXYGENATOR IN THE TREATMENT OF FIVE PATIENTS WITH REFRACTORY CARDIOGENIC SHOCK AFTER ACUTE MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. PATIENT PRESENTED WITH COMPLAINTS OF SEVERE SUBSTERNAL CHEST PAIN. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO THE EMERGENCY DEPARTMENT. BEFORE CARDIAC CATHETERIZATION, THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION AND WAS SUCCESSFULLY DEFIBRILLATED AND INTUBATED. CORONARY ANGIOGRAPHY DEMONSTRATED A 100% OCCLUSION OF THE DISTAL LEFT MAIN ARTERY, A 70% OCCLUSION OF THE DISTAL RCA, AND NONOBSTRUCTIVE LAD AND LCX ARTERIES. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED. THROMBECTOMY OF THE LEFT MAIN ARTERY THROMBUS WAS ATTEMPTED, AND STENTING WAS PERFORMED WITH THE PLACEMENT OF A 3.5 X 28 MM VISION. POSTSTENT ANGIOGRAPHY DEMONSTRATED GRADE II THROMBOLYSIS IN MYOCARDIAL INFARCTION FLOW. DURING THE PROCEDURE, THE PATIENT DEVELOPED CARDIOGENIC SHOCK. HEMODYNAMIC ASSESSMENT REVEALED HYPOTENSION. SUBSEQUENTLY, THE PATIENT SUSTAINED PULSELESS POLYMORPHIC VENTRICULAR TACHYCARDIA, WHICH REQUIRED 30 MINUTES OF CARDIOPULMONARY RESUSCITATION AND MULTIPLE DEFIBRILLATIONS AND MEDICATIONS. A TANDEMHEART OXYGENATOR (THO) WAS PLACED AND PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC INTENSIVE CARE UNIT. APPROXIMATELY 3 WEEKS POST PROCEDURE, THE PATIENT DEVELOPED ACUTE RESPIRATORY DISTRESS REQUIRING VENTILATOR SUPPORT. THE PATIENTS HEMODYNAMICS IMPROVED AND THE THO WAS EXPLANTED; HOWEVER, SEVERAL DAYS LATER DEVELOPED ASYTOLE AND WAS UNABLE TO BE RESUSCITATED RESULTING IN DEATH. POSTMORTEM FINDINGS REVEALED AN EXTENSIVE MYOCARDIAL INFARCTION INVOLVING MORE THAN 90% OF THE LEFT VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194743 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death OTHER: TANDOMHEART OXYGENATOR