BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE CARDIOFORM SEPTAL OCCLUDER

    MDR report key: 8042616 · Received November 6, 2018

    Report

    Report Number
    2017233-2018-00662
    Event Type
    Death
    Date Received
    November 6, 2018
    Date of Event
    October 8, 2018
    Report Date
    November 13, 2020
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    UDI-DI
    00733132631025
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING EVALUATION: IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 25MM GORE¿ CARDIOFORM SEPTAL OCCLUDER TO CLOSE AN OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT (ASD) WITH A 7MM STATIC MEASUREMENT. THE DEFECT WAS NOT BALLOON SIZED. THE RETRO AORTIC RIM WAS PRESENT BUT SLIGHTLY DEFICIENT AND WAS NOT MEASURED. THE INFERIOR RIM WAS ROBUST AND MEASURED 7.5MM. THE PATIENT HAD A PROMINENT EUSTACHIAN VALVE, CARE WAS TAKEN BY THE PHYSICIAN TO MAKE SURE THE DEVICE WAS DEPLOYED IN THE TRUE SEPTUM AND NOT IN THE EUSTACHIAN VALVE. UPON REVIEWING THE ECHOCARDIOGRAPHIC IMAGING, THE STATIC DEFECT DIAMETER WAS APPROXIMATELY 7MM IN SOME TEE VIEWS AND UNDETERMINABLE IN OTHER VIEWS WITH COLOR. NO MEASUREMENTS WERE RECORDED IN THE RETURNED IMAGING TO CONFIRM THE 7MM MEASUREMENT, AND STOP FLOW BALLOON SIZING WAS NOT PERFORMED. AN ANATOMICAL ANOMALY WAS NOTED AND DESCRIBED AS EITHER A PROMINENT EUSTACHIAN VALVE, A MAL-ATTACHED SEPTUM, OR COR TRIATRIATUM. CONFIRMATION OF THIS ANATOMICAL DESCRIPTION WOULD HAVE TO BE PROVIDED BY AN ECHOCARDIOLOGIST. THE PROCEDURAL FLUOROSCOPIC IMAGING WAS ALSO EVALUATED. RETURNED IMAGES OF THE DEPLOYED, LOCKED, AND RELEASED OCCLUDER WERE PROVIDED. THE DEPLOYED OCCLUDER SHOWS A POTENTIAL PARTIAL PROLAPSE OF THE LEFT DISC INTO THE RIGHT ATRIUM. THIS COULD NOT BE CONFIRMED ON THE TEE IMAGES FOR THE DEPLOYED DEVICE. UPON LOCKING OF THE OCCLUDER, THE DEVICE PROJECTED FORWARD WHICH IS CONSISTENT WITH THE FORWARD MOVEMENT OF THE HANDLE, OR A BEND IN THE CATHETER PRIOR TO LOCKING. THE DELIVERY SYSTEM WAS WITHDRAWN TO ACHIEVE A FLAT RIGHT DISC. THE OCCLUDER REMAINED LOCKED. ON THE FLUOROSCOPIC IMAGES, THE LOCKED OCCLUDER ALSO SHOWED A POTENTIAL PARTIAL PROLAPSE OF THE LEFT DISC INTO THE RIGHT ATRIUM. TEE IMAGES DID NOT SHOW A RESIDUAL SHUNT, HOWEVER, IN THE AORTIC SHORT AXIS VIEW, THE LEFT DISC APPEARS TO BE PROLAPSED INTO THE RIGHT ATRIUM ON THE ANTERIOR SUPERIOR RIM. THE DEVICE WAS INTERROGATED FOR RESIDUAL SHUNTS AROUND THE DEVICE AND NONE WERE NOTED, AND THE DEVICE WAS RELEASED. APPROXIMATELY ONE HOUR POST PROCEDURE, THE PATIENT WAS AWAKE AND CONSCIOUS. THE PATIENT DESATURATED FROM THE HIGH 90'S TO THE 30'S. CPR COMMENCED AND CONTINUED FOR 45 MINUTES UNTIL CARDIAC SUPPORT WAS ACHIEVED IN THE OPERATION ROOM. THE PATIENT'S SATURATIONS WERE DESCRIBED AS GOOD DURING CPR. THE OCCLUDER WAS REMOVED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) SURGICALLY. THE OPERATING SURGEON NOTED A SINUS VENOSUS ASD -THAT WAS NOT PREVIOUSLY SEEN ON ECHO- IN ADDITION TO THE OSTIUM SECUNDUM ASD. FOLLOWING SURGERY THE PATIENT REMAINED ON LIFE SUPPORT FOR ONE WEEK POST SURGERY WITHOUT RECOVERY. THE REASON FOR THE ACUTE DESATURATION OF THE PATIENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THE DEVICE WAS SURGICALLY REMOVED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), AND A POTENTIAL PARTIAL PROLAPSE OF THE LEFT DISC INTO THE RIGHT ATRIUM APPEARS ON IMAGING AFTER LOCKING, AND RELEASE OF THE OCCLUDER ON FLUOROSCOPY AND TEE. HOWEVER IT CANNOT BE DETERMINED IF THE DEVICE EMBOLIZED INTO THE RVOT BEFORE CPR POTENTIALLY LEADING TO THE RAPID DESATURATION OF THE PATIENT, OR IF PATIENT RAPIDLY DESATURATED AND THEN THE CPR LEAD TO THE DEVICE EMBOLIZATION. ENGINEERING EVALUATION: IT WAS REPORTED FOLLOWING THE PROCEDURE THE DEVICE EMBOLIZED AND WAS REMOVED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT. THE OCCLUDER WAS RETURNED TO GORE FOR ANALYSIS. THE INVESTIGATION REVEALED THAT THE SIZE AND SHAPE OF THE OCCLUDER AND LOCK LOOP WERE UNREMARKABLE. THE INVESTIGATION ALSO REVEALED THAT THE FACE HOLE WAS PRESENT PER SPECIFICATION. THE CAUSE OF THE EMBOLIZED OCCLUDER IS UNKNOWN AND CANNOT BE DETERMINED FROM THE EVIDENCE AVAILABLE.

    Additional Manufacturer Narrative · 1

    GORE RECEIVED THE PATIENT'S MEDICAL HISTORY WHICH HAS BEEN PROVIDED IN AN ATTACHMENT WITH THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 25MM GORE¿ CARDIOFORM SEPTAL OCCLUDER TO CLOSE AN OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT (ASD) WITH A 7MM STATIC MEASUREMENT. IT WAS ALSO REPORTED THAT THE DEFECT WAS NOT BALLOON SIZED. IT WAS REPORTED THE INFERIOR RIM WAS ROBUST AND MEASURED 7.5MM. IT WAS FURTHER REPORTED THE PATIENT HAD A PROMINENT EUSTACHIAN VALVE, CARE WAS TAKEN BY THE PHYSICIAN TO MAKE SURE THE DEVICE WAS DEPLOYED IN THE TRUE SEPTUM AND NOT IN THE EUSTACHIAN VALVE. ACCORDING TO THE REPORT, THE DEVICE WAS REPOSITIONED BEFORE HAVING A FINAL DEPLOYMENT. APPROXIMATELY ONE HOUR POST PROCEDURE, IT WAS REPORTED THE PATIENT WAS AWAKE AND CONSCIOUS. IT WAS FURTHER REPORTED THE PATIENT DESATURATED FROM THE HIGH 90'S TO THE 30'S. IT WAS REPORTED THAT CPR COMMENCED AND CONTINUED FOR 45 MINUTES UNTIL CARDIAC BYPASS WAS ACHIEVED IN THE OPERATION ROOM. ACCORDING TO THE REPORT, THE PATIENT'S SATURATIONS WERE DESCRIBED AS GOOD DURING CPR. IT WAS REPORTED THE OCCLUDER WAS REMOVED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) SURGICALLY. IT WAS REPORTED THE OPERATING SURGEON NOTED A SINUS VENOSUS ASD -THAT WAS NOT PREVIOUSLY SEEN ON ECHO- IN ADDITION TO THE OSTIUM SECUNDUM ASD. FOLLOWING SURGERY, IT WAS REPORTED THE PATIENT REMAINED ON LIFE SUPPORT. IF WAS FURTHER REPORTED APPROXIMATELY ONE WEEK POST SURGERY, THE PATIENT WAS TAKEN OFF LIFE SUPPORT. AT THIS TIME, IT IS UNCLEAR THE CAUSE OF THE PATIENT'S DESATURATION AND CAUSE OF THE DEVICE EMBOLIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 25MM GORE¿ CARDIOFORM SEPTAL OCCLUDER TO CLOSE AN OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT (ASD) WITH A 7MM STATIC MEASUREMENT. IT WAS ALSO REPORTED THAT THE DEFECT WAS NOT BALLOON SIZED. IT WAS REPORTED THE INFERIOR RIM WAS ROBUST AND MEASURED 7.5MM. IT WAS FURTHER REPORTED THE PATIENT HAD A PROMINENT EUSTACHIAN VALVE. CARE WAS TAKEN BY THE PHYSICIAN TO MAKE SURE THE DEVICE WAS DEPLOYED IN THE TRUE SEPTUM AND NOT IN THE EUSTACHIAN VALVE. ACCORDING TO THE REPORT, THE DEVICE WAS REPOSITIONED BEFORE HAVING A FINAL DEPLOYMENT. APPROXIMATELY ONE HOUR POST PROCEDURE, IT WAS REPORTED THE PATIENT WAS AWAKE AND CONSCIOUS. IT WAS FURTHER REPORTED THE PATIENT DESATURATED FROM THE HIGH 90'S TO THE 30'S. IT WAS REPORTED THAT CPR COMMENCED AND CONTINUED FOR 45 MINUTES UNTIL CARDIAC SUPPORT WAS ACHIEVED IN THE OPERATION ROOM. ACCORDING TO THE REPORT, THE PATIENT'S SATURATIONS WERE DESCRIBED AS GOOD DURING CPR. IT WAS REPORTED THE OCCLUDER WAS REMOVED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) SURGICALLY. IT WAS REPORTED THE OPERATING SURGEON NOTED A SINUS VENOSUS ASD -THAT WAS NOT PREVIOUSLY SEEN ON ECHO- IN ADDITION TO THE OSTIUM SECUNDUM ASD. FOLLOWING SURGERY IT WAS REPORTED THE PATIENT REMAINED ON LIFE SUPPORT. IT WAS FURTHER REPORTED APPROXIMATELY ONE WEEK POST SURGERY THE PATIENT WAS TAKEN OFF LIFE SUPPORT WITHOUT RECOVERY. AT THIS TIME IT IS UNCLEAR THE CAUSE OF THE PATIENT'S DESATURATION AND CAUSE OF THE DEVICE EMBOLIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS IMPLANTING A 25MM GORE® CARDIOFORM SEPTAL OCCLUDER TO CLOSE AN OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT (ASD) WITH A 7MM STATIC MEASUREMENT. IT WAS ALSO REPORTED THAT THE DEFECT WAS NOT BALLOON SIZED. IT WAS REPORTED THE INFERIOR RIM WAS ROBUST AND MEASURED 7.5MM. IT WAS FURTHER REPORTED THE PATIENT HAD A PROMINENT EUSTACHIAN VALVE. CARE WAS TAKEN BY THE PHYSICIAN TO MAKE SURE THE DEVICE WAS DEPLOYED IN THE TRUE SEPTUM AND NOT IN THE EUSTACHIAN VALVE. ACCORDING TO THE REPORT, THE DEVICE WAS REPOSITIONED BEFORE HAVING A FINAL DEPLOYMENT. APPROXIMATELY ONE HOUR POST PROCEDURE, IT WAS REPORTED THE PATIENT WAS AWAKE AND CONSCIOUS. IT WAS FURTHER REPORTED THE PATIENT DESATURATED FROM THE HIGH 90'S TO THE 30'S. IT WAS REPORTED THAT CPR COMMENCED AND CONTINUED FOR 45 MINUTES UNTIL CARDIAC SUPPORT WAS ACHIEVED IN THE OPERATION ROOM. ACCORDING TO THE REPORT, THE PATIENT'S SATURATIONS WERE DESCRIBED AS GOOD DURING CPR. IT WAS REPORTED THE OCCLUDER WAS REMOVED FROM THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) SURGICALLY. IT WAS REPORTED THE OPERATING SURGEON NOTED A SINUS VENOSUS ASD -THAT WAS NOT PREVIOUSLY SEEN ON ECHO- IN ADDITION TO THE OSTIUM SECUNDUM ASD. FOLLOWING SURGERY IT WAS REPORTED THE PATIENT REMAINED ON LIFE SUPPORT. IT WAS FURTHER REPORTED APPROXIMATELY ONE WEEK POST SURGERY THE PATIENT WAS TAKEN OFF LIFE SUPPORT WITHOUT RECOVERY. AT THIS TIME IT IS UNCLEAR THE CAUSE OF THE PATIENT'S DESATURATION AND CAUSE OF THE DEVICE EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880640 GORE CARDIOFORM SEPTAL OCCLUDER TRANSCATHETER, SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES GSX0025A 18096319 00733132631025

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death| O