BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5488817 · Received March 9, 2016

    Report

    Report Number
    1058196-2016-00025
    Event Type
    Death
    Date Received
    March 9, 2016
    Date of Event
    August 3, 2015
    Report Date
    February 16, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL REPORT FOR (B)(4) WITH MDR REPORT NUMBER OF 1058196-2016-00025. ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI IS UNAVAILABLE. CONCOMITANT DEVICES: 6-FR SHUTTLE SHEATH (COOK MEDICAL), HEADAWAY 17 MICROCATHETER (MICROVENTION), PROWLER SELECT PLUS MICROCATHETER (CODMAN) AND BALLOON CATHETER (RAFALE, HEXACATH OR TAZUNA, TERUMO). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. LEE, K-Y., CHEN D.Y-T., HSU, H-L., CHEN, C-J., TSENG, Y-C( 2015, AUG 3)UNDERSIZED ANGIOPLASTY AND STENTING OF SYMPTOMATIC INTRACRANIAL TIGHT STENOSIS WITH ENTERPRISE: EVALUATION OF CLINICAL AND VASCULAR OUTCOME. INTERVENTIONAL NEURORADIOLOGY 0 (00) 1¿9. DOI: 10.1177/1591019915609165.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "UNDERSIZED ANGIOPLASTY AND STENTING OF SYMPTOMATIC INTRACRANIAL TIGHT STENOSIS WITH ENTERPRISE: EVALUATION OF CLINICAL AND VASCULAR OUTCOME" BY KUN-YU LEE, DAVID YEN-TING CHEN, HUI-LING HSU, CHI-JEN CHEN AND YING-CHI TSENG, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 0(00) 1-9 DOI: 10.1177/1591019915609165, IT WAS REPORTED THAT THREE PATIENTS HAD POST PROCEDURE COMPLICATIONS WITHIN 30 DAYS OF THE INDEX PROCEDURE, 1 CASE OF INTRACRANIAL HEMORRHAGE, 1 CASE OF IN-STENT THROMBOSIS AND 1 CASE OF ISCHEMIC STROKE. ALSO REPORTED WAS AN INSTENT STENOSIS EVENT AT 18 MONTHS POST PROCEDURE THAT HAS BEEN PREVIOUSLY CAPTURED AS A COMPLAINT (MDR REPORT NUMBER 1058196-2016-00020 (B)(4)). THE ARTICLE WAS PUBLISHED TO ADDRESS THE ISSUE OF SEVERE INTRACRANIAL ARTERIAL STENOSIS RESULTS IN MORE THAN 10% INCIDENCE OF STROKE AND TRANSIENT ISCHEMIC ATTACK. USING UNDERSIZED ANGIOPLASTY WITH OFF-LABEL CLOSED-CELL ENTERPRISE STENT MAY BE A FEASIBLE ALTERNATIVE OPTION FOR TREATING PATIENTS WITH INTRACRANIAL ATHEROSCLEROTIC DISEASE WHO FAIL DUAL-ANTIPLATELET MEDICAL THERAPY. STENT DEPLOYMENT WAS SUCCESSFULLY ACHIEVED IN ALL STENOTIC LESIONS (30/30). MEAN PRE-STENT AND POST-STENT DIAMETER RESIDUAL STENOSIS WAS 81% AND 18%, RESPECTIVELY. THE PERI-PROCEDURAL COMPLICATION RATE DURING 30 DAYS AFTER STENTING WAS 10% PER LESION (3/30), INCLUDING INTRACRANIAL HEMORRHAGE, IN-STENT THROMBOSIS AND ISCHEMIC STROKE. NO FURTHER THROMBOEMBOLIC EVENT OR COMPLICATION OCCURRED IN ANY PATIENT MORE THAN 30 DAYS AFTER STENTING. EARLY POST-PROCEDURAL COMPLICATIONS, WITHIN 30 DAYS AFTER THE PROCEDURE, WERE REPORTED IN THREE OF 30 TREATED LESIONS (10%). ALL THE THREE ADVERSE EVENTS WERE RELATED TO THE TREATED ANGIOPLASTY AND STENTING TERRITORY. THE PATIENT WITH RIGHT MCA TIGHT STENOSIS, SUFFERED FROM REPERFUSION HEMORRHAGE AFTER PERCUTANEOUS TRANSARTERIAL BALLOON ANGIOPLASTY AND STENTING (PTAS). DURING PTAS, THE PATIENT'S SYSTOLIC BLOOD PRESSURE WAS CONTROLLED UNDER 120 MMHG, AND POST-STENTING ANGIOGRAPHY SHOWED PATENCY OF THE TREATED SEGMENT WITHOUT CONTRAST EXTRAVASATION OR ARTERIAL DISSECTION. HOWEVER, THIS PATIENT EXPERIENCED DRAMATICALLY ELEVATED UNCONTROLLED BLOOD PRESSURE (VARYING FROM 160/90 TO 200/110 MMHG) AND BECAME RESTLESS DURING RECOVERY FROM ANESTHESIA. AN EMERGENT BRAIN COMPUTED TOMOGRAPHY SCAN REVEALED EXTENSIVE RIGHT PUTAMINAL HEMORRHAGE EXTENDING INTO THE VENTRICLE. SURGICAL MANAGEMENT WAS PERFORMED FOR HEMATOMA EVACUATION. HIS CONSCIOUSNESS DETERIORATED AND HE DEVELOPED HYPERVENTILATION WITH SEVERE HYPOCAPNIA DUE TO BRAINSTEM DYSFUNCTION, AND EVENTUALLY DIED 10 DAYS AFTER THE PROCEDURE. THIS WAS THE ONLY MORTALITY SHOWN IN THIS STUDY. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THE PATIENT WITH ISCHEMIC STROKE HAS BEEN CAPTURED UNDER MDR REPORT 1058196-2016-00027 ((B)(4)) AND THE PATIENT WITH IN-STENT THROMBOSIS HAS BEEN CAPTURED UNDER MDR REPORT NUMBER 1058196-2016-00026 ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144989 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death