BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7099673 · Received December 8, 2017

    Report

    Report Number
    9612164-2017-01846
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    February 1, 2017
    Report Date
    May 3, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE PATIENT'S CURRENT STATUS IS STABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT DATE - MONTH AND YEAR VALID. IMPLANT DATE - MONTH AND YEAR VALID. (B)(4) CASE REPORTS "SPONTANEOUS CLOSURE OF VENTRICULAR SEPTAL PERFORATION FOLLOWING PERCUTANEOUS CORONARY INTERVENTION FOR ACUTE MYOCARDIAL INFARCTION" DOI:10.1136/BCR-2017-221204. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IMAGES PROVIDE SHOW THAT TRANSTHORACIC ECHOCARDIOGRAPHY ON ADMISSION REVEALED DECREASED ANTEROSEPTAL WALL MOVEMENT WITH A LOW LEFT VENTRICULAR EJECTION OF 35% . CORONARY ANGIOGRAPHY REVEALED 90% STENOSIS AT #6 (OSTIUM) AND OCCLUSION AT #7 (C), AND PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. TWO RESOLUTE INTEGRITY STENTS WERE PLACED, AND THE PROCEDURE WAS CONCLUDED WITH TIML3 FLOW WITHOUT COMPLICATIONS . TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED A LEFT-TO-RIGHT SHUNT WITH A 2.7 MM DIAMETER DEFECT IN THE REGION OF THE APICAL SEPTAL AKINESIS, AND A VENTRICULAR SEPTAL PERFORATION WAS DIAGNOSED. THE DISAPPEARANCE OF THE CARDIAC MURMUR AND THE LEFT-TO-RIGHT SHUNT WAS CONFIRMED ON HOSPITAL DAY 3 THE NEXT DAY VENTRICULAR SEPTAL PERFORATION WAS CONFIRMED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE SYSTOLIC MURMUR WAS NOT RELATED TO THE IMPLANTED RESOLUTE STENTS THE LEFT-TO-RIGHT SHUNT OF APPROXIMATELY 2. 7 MM THAT WAS NOTED IN THE REGION OF THE APICAL SEPTAL AKINESIS WAS NOT RELATED TO THE IMPLANTED RESOLUTE STENTS THE VENTRICULAR SEPTAL PERFORATION WAS NOT RELATED TO THE RESOLUTE STENTS A THROMBUS WAS CONFIRMED IN THE VENTRICLES. THERE WAS NO ISSUE WITH THE IMPLANTED RESOLUTE AND NO THROMBUS WAS CONFIRMED INSIDE IT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INDEX PROCEDURE WAS PROMPTED BY MYOCARDIAL INFARCTION. DURING THE PROCEDURE, TWO RESOLUTE INTEGRITY DRUG ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL AND MID LAD SUCCESSFULLY. POST OPERATIVELY, NO MURMUR WAS AUDIBLE ON AUSCULTATION AND NO SHUNT FLOW WAS OBSERVED ON TRANSTHORACIC ECHOCARDIOGRAPHY AND NORMAL BLOOD PRESSURE WAS MAINTAINED. A DAY LATER THE PATIENT'S VITAL PARAMETERS DETERIORATED TO A STATE OF SHOCK WITH A SYSTOLIC BLOOD PRESSURE OF APPROXIMATELY 70MMHG. AUSCULTATION REVEALED A SYSTOLIC MURMUR WITH AN APICAL THRILL THAT WAS NOT DETECTED AT ADMISSION. PATIENT WAS TREATED WITH MEDICATION AND ACUTE HEART FAILURE SUBSEQUENTLY IMPROVED. THE DETERIORATION OF THE VITAL PARAMETERS OF THE PATIENT TO A STATE OF SHOCK AND AKINESIS ALONG WITH THE CONSEQUENT DECREASE IN BLOOD IN AREAS ALREADY SUFFERING FROM LOW BLOOD FLOW MAY HAVE COMBINED IN A COMPLEX MANNER TO PROMOTE THROMBUS FORMATION, RESULTING IN ITS SPONTANEOUS CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878612 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0008090897

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other