BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRAGG-MCNAMARA

    MDR report key: 14298305 · Received May 6, 2022

    Report

    Report Number
    2029214-2022-00781
    Event Type
    Death
    Date Received
    May 6, 2022
    Date of Event
    April 3, 2019
    Report Date
    January 18, 2023
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K940634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    G3 510K INFORMATION CORRECTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    2022-APR-06 LIT (HCP, LIT): AMALIA A. WINTERS, MICHAEL J. MCDANIELB, JOSE N. BINONGO, RENA C. MOON, WISSAM A. JABERB, RAVI R. RAJANI, HENRY A. LIBERMAN, OMAR M. LATTOUF, MICHAEL E. HALKOS, CHADWICK W. STOUFFERA, W. BRENT KEELING; INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY; 2020; 30: 388-393; A COMPARISON OF SURGICAL PULMONARY EMBOLECTOMY AND CATHETER-DIRECTED LYSIS FOR LIFE-THREATENING PULMONARY EMBOL; DOI:10.1093/ICVTS/IVZ288 MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE OF PATIENTS TREATED WITH A CRAGG-MCNAMARA INFUSION CATHETER. THE PURPOSE OF THIS STUDY WAS TO COMPARE POSTOPERATIVE OUTCOMES BETWEEN CATHETER-DIRECTED THROMBOLYSIS (CDL) AND SURGICAL PULMONARY EMBOLECTOMY (SPE) IN THE TREATMENT OF LIFE-THREATENING PULMONARY EMBOLECTOMY (PE). A RETROSPECTIVE SINGLE-CENTER OBSERVATIONAL STUDY WAS CONDUCTED FOR PATIENTS WHO UNDERWENT SPE OR CDL AT A SINGLE US ACADEMIC CENTER. PREPROCEDURAL AND POSTPROCEDURAL ECHOCARDIOGRAPHIC DATA WERE COLLECTED. A TOTAL OF 126 PATIENTS WHO UNDERWENT EITHER SPE (60 PATIENTS, 47.6%) OR CDL (66, 52.4%) WERE INCLUDED IN THIS STUDY. THE DECISION TO PURSUE CDL WAS DETERMINED BY A MULTIDISCIPLINARY PE RESPONSE TEAM. ALL PATIENTS RECEIVED LOCAL TISSUE PLASMINOGEN ACTIVATOR (TPA) THROUGH STANDARD INFUSION CATHETERS; UNIFUSE (ANOTHER MANUFACTURER),  OR CRAGG-MCNAMARA OR ULTRASOUND-ASSISTED CATHETERS (ANOTHER MANUFACTURE). MOST PATIENTS RECEIVED BILATERAL TREATMENT WITH 2 CATHETERS. WHILE TPA INFUSIONS VARIED, THE TYPICAL DOSE WAS 0.5¿1 MG/H PER CATHETER AND THE DURATION OF INFUSION WAS TYPICALLY < 24 H. SOME PATIENTS WERE TREATED FOR MORE THAN 24 H WHEN PULMONARY ARTERY PRESSURES DID NOT DECREASE SIGNIFICANTLY OR WHEN ANGIOGRAPHY SHOWED LITTLE THROMBUS RESOLUTION. UNFRACTIONATED HEPARIN WAS DELIVERED DURING TPA INFUSION AT 5¿10 U/KG/H NOT TO EXCEED 1000 U/H OR A LOW STANDARD PROTOCOL WITH HEPARIN LEVEL MONITORING PER UNIT PROTOCOL. AT 1¿2 H AFTER TERMINATION OF THROMBOLYSIS, THE HIGH-INTENSITY HEPARIN PROTOCOL WAS RESUMED. IN GENERAL, PULMONARY ARTERIAL PRESSURES WERE ASSESSED AT COMMENCEMENT AND AT THE TERMINATION OF THE INFUSION, AND TREATMENT DECISIONS WERE BASED ON THE DEGREE OF PRESSURE DECREASE MEASURED. SIXTEEN (26.7%) SPE PATIENTS HAD A CONCOMITANT PROCEDURE PERFORMED. THESE CONSISTED OF 7 PATIENTS WHO UNDERWENT PATENT FORAMEN OVALE CLOSURE, 4 WITH CONCOMITANT RIGHT ATRIAL EXPLORATION FOR THROMBUS IN TRANSIT, 3 WHO UNDERWENT CORONARY ARTERY BYPASS GRAFTING, 1 PATIENT WHO REQUIRED AORTIC AND MITRAL VALVE REPLACEMENT AND 1 PATIENT WHO UNDERWENT AN IVC THROMBECTOMY. THROMBOLYTICS WERE INFUSED FOR A MEDIAN OF 24 H (IQR 18.0¿25.0), WITH A MEDIAN TPADOSE OF 24.0 MG (IQR 18.0¿25.0). FORTY-EIGHT PATIENTS (72.7%) HAD BILATERAL CATHETERS, AND 18 (27.3%) HAD A SINGLE CATHETER PLACED IN EITHER THE RIGHT OR LEFT PULMONARY ARTERIAL TREE. INFERIOR VENA CAVA FILTERS WERE PLACED IN 39 (65.0%) AND 32 (48.5) PATIENTS WHO UNDERWENT SPE AND CDL, RESPECTIVELY. TWO PATIENTS IN THE SPE GROUP (3.3%) AND 2 PATIENTS IN THE CDL GROUP (3.0%) SUFFERED IN-HOSPITAL MORTALITY RATE. SPE PATIENTS HAD A SIGNIFICANTLY HIGHER INCIDENCE OF PROLONGED VENTILATION (15.0% VS 1.5%, P = 0.01). THE INCIDENCE OF MAJOR BLEEDING REQUIRING TRANSFUSION WAS ALSO HIGHER IN THE SPE COHORT (MEAN UNITS OF BLOOD 1.6 ± 3.5 VS 0.4 ± 1.3, P = 0.01). OTHERWISE, THERE WAS NO SIGNIFICANT DIFFERENCE IN OUTCOMES INCLUDING POSTPROCEDURAL PNEUMONIA, ATRIAL FIBRILLATION, RENAL FAILURE OR 30-DAY READMISSION. THERE WERE NO INTRACRANIAL HAEMORRHAGES IN EITHER GROUP. NINETY-SEVEN PATIENTS (78%) HAD BASELINE ECHOCARDIOGRAPHIC DATA AVAILABLE FOR REVIEW, AND 52 (41%) HAD A MIDTERM ECHOCARDIOGRAPHIC FOLLOW-UP. MEDIAN ECHOCARDIOGRAPHIC FOLLOW-UP WAS 4 MONTHS (RANGE 1 DAY¿36 MONTHS). IN THE CDL GROUP, 33 (56.9%) PATIENTS HAD MODERATE OR SEVERE RIGHT VENTRICULAR (RV) DYSFUNCTION AT BASELINE, WHICH DECREASED TO 2 (6.5%) PATIENTS AT MIDTERM FOLLOW-UP (P < 0.001). RV SYSTOLIC PRESSURE ALSO IMPROVED, DECREASING FROM 52.9 MMHG (IQR 42.2¿66.3) AT BASELINE TO 27.9 (20.0¿35.5), P < 0.0001. IN THE SPE GROUP, MORE PATIENTS HAD MODERATE OR SEVERE RV DYSFUNCTION AT BASELINE (30, 76.9%), BUT ONLY 4 PATIENTS (19.0%) HAD MODERATE OR WORSE RV DYSFUNCTION AT MIDTERM FOLLOW-UP (P < 0.001). RV SYSTOLIC PRESSURE ALSO IMPROVED IN THE SPE GROUP FROM BASELINE TO MIDTERM [52.0 MMHG (40.0¿60.8) TO 35.6 (28.5¿51.0), P <_ 0.01]. MORTALITY RATES FOR PATIENTS WITH PE VARY ACCORDING TO THE DEGREE OF RV DYSFUNCTION. PATIENTS WITH DOCUMENTED RV DYSFUNCTION IN THE ABSENCE OF HAEMODYNAMIC INSTABILITY EXPERIENCE AN IN- HOSPITAL MORTALITY RATE OF 5¿15%, BUT WHEN RV DYSFUNCTION IS SO SEVERE AS TO COMPROMISE CARDIAC OUTPUT, MORTALITY RATES RISE TO IN EXCESS OF 50%. ONCE THESE PATIENTS LEAVE THE HOSPITAL, THERE IS AN ONGOING MORTALITY RISK, AS NOTED BY THE 21% MORTALITY RATE FOR PATIENTS WHO SUFFER FROM SUB-MASSIVE PE AT 3 MONTHS AFTER INITIAL DIAGNOSIS [7]. THE NEED FOR BETTER TREATMENT ALGORITHMS FOR PATIENTS WHO SUFFER FROM LIFE-THREATENING PE IS APPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413523 CRAGG-MCNAMARA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CRAGG-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death