BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 5322411 · Received December 23, 2015

    Report

    Report Number
    9612164-2015-01948
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    January 1, 2014
    Report Date
    December 7, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A. NEMES, P. HAUSINGER1 · V. SASI1 · G. VOLFORD2 · M. BITAY3 · G. BOGÁTS3 · A. THURY1 · A. PALKÓ4 · T. FORSTER E-HERZ: CASE STUDY, 2014 HERZ 2014 · 39:770¿773 UNRUPTURED ANEURYSM OF THE LEFT SINUS OF VALSALVA COMPRESSING THE LEFT MAIN CORONARY ARTERY.

    Additional Manufacturer Narrative · 1

    EVENT DATE - DATE OF PUBLICATION YEAR VALID ONLY. THE PROCEDURAL STILL IMAGES PROVIDED IN THE CASE STUDY LITERATURE SHOWS THE NARROWING OF THE LCX. THE IMAGES DO NOT PROVIDE ANY CONCLUSION TO THE ROOT CAUSE OF THE REPORTED EVENT (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS INTEGRITY BARE METAL STENT. THE PATIENT WAS HOSPITALIZED AND A CORONARY ANGIOGRAPHY REVEALED PROXIMAL SUB OCCLUSION OF THE LEFT CIRCUMFLEX ARTERY (LCX) BY EXTRINSIC COMPRESSION OF THE LSVA. THE PATIENT HAD ONE INTEGRITY RX BARE METAL STENT (4X18MM) IMPLANTED IN THE LCX. FOLLOWING SUCCESSFUL LCX-PCI, CHEST SYMPTOMS DISAPPEARED AND CORONARY COMPUTED TOMOGRAPHY (CT) ANGIOGRAPHY CONFIRMED THE PRESENCE OF THE LSVA. 30 HRS POST PROCEDURE SUDDENLY DEVELOPED CARDIOGENIC SHOCK WITH SEVERE ANGINA AND STD. EMERGENCY SURGERY WAS PERFORMED UNDER CONVENTIONAL CARDIOPULMONARY BYPASS. ANEURYSM LEFT CORONARY OSTIUM AND THE ANNULUS OF THE BAV WAS CONFIRMED AND CAUSED COMPRESSION OF THE LCX AND LMCA. A PROSTHETIC VALVE (NON MDT) WAS IMPLANTED TO TREAT THE ANEURYSM AT THE LEVEL OF THE SUTURE LINE RESULTING IN THE EXCLUSION OF THE LSVA FROM THE AORTIC ROOT. CORONARY FLOW WAS SECURED BY SAPHENOUS VEIN (SV) BYPASS TO THE LEFT ANTERIOR DESCENDING (LAD) AND LCX ARTERIES. THEIR ARE NO FURTHER CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847524 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND INT40018X

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention