BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    MDR report key: 4144413 · Received October 6, 2014

    Report

    Report Number
    2015691-2014-02327
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. WHILE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, A FLUORO SCREEN PHOTOGRAPH WAS RECEIVED SHOWING THE MARKER DISLODGED, THEREFORE THE COMPLAINT OF "SHEATH DISTAL TIP - SEPARATED MARKER" IS CONFIRMED. THE DEVICE HISTORY RECORD (DHR) REVIEW OF THE AFFECTED DEVICE SHOWED THE DEVICE MET SPECIFICATIONS PRIOR TO DISTRIBUTION OF DEVICE. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. AS PART OF THE MANUFACTURING PROCESS THE ESHEATH DEVICE UNDERGOES MULTIPLE 100% INSPECTIONS BY MANUFACTURING AND QUALITY. THESE INSPECTIONS SUPPORT THAT IT IS UNLIKELY A MANUFACTURING NON-CONFORMANCE WAS THE SOURCE OF THE COMPLAINT. PER THE REPORT RECEIVED, ¿MANY ATTEMPTS WERE MADE AT SECURING THE VALVE IN THE ASCENDING AORTA BY INFLATING THE BAV AT SPECIFIC LOCATIONS. THAT IN TURN CAUSED THE BAV ON THE SYSTEM TO BURST, FORCING THE PHYSICIANS TO RETRACT THE DEVICE. WHILE REMOVING THE NF+ SYSTEM, THE NOW SHRIVELED BAV BALLOON STAYED CAUGHT ON THE DISTAL PORTION OF THE SLIT ESHEATH. THE DISTAL PORTION OF THE CATHETER FROM THE NOSE CONE ALL THE WAY TO THE VALVE MARKERS, AS WELL AS THE MARKER INDICATING THE TIP OF THE ESHEATH DISLODGED AND REMAINED IN THE PATIENT'S ABDOMINAL AORTA WHILE THE REST OF THE SYSTEM WAS RETRACTED." IF THERE WAS DIFFICULTY RETRACTING THE DEVICES INTO THE SHEATH, THE LINER MAY HAVE DELAMINATED FROM THE HDPE, EXPOSING THE MARKER BAND AND RESULTING IN THE DISLODGMENT. IN THIS CASE, THE COMPLAINT WAS CONFIRMED. THE AVAILABLE INFORMATION SUGGESTS THE PROCEDURAL FACTORS MENTIONED ABOVE MAY HAVE CONTRIBUTED TO THE MARKER DISLODGMENT AND DEVICE COMPONENT SEPARATION. THERE WERE NO REPORTS OF ADDITIONAL PATIENT SEQUELA AS A RESULT OF THIS EVENT. CORRECTIVE ACTIONS HAVE BEEN INITIATED FOR THIS FAILURE MODE. PLEASER REFERENCE RELATED MANUFACTURER REPORTS: 2015691-2014-02324; 2015691-2014-02326 AND 2015691-2014-02327.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE SITE. A NO PRODUCT RETURN INVESTIGATION HAS BEEN REQUESTED. THE EVENT OF THE VALVE EMBOLIZATION IS REPORTED UNDER MDR REPORT NUMBER 2015691-2014-02324. THE EVENT OF THE BALLOON BURST IS REPORTED UNDER MDR REPORT NUMBER 2015691-2014-02326.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) AFFILIATES, DURING ATTEMPTS TO SECURE AN EMBOLIZED VALVE, THE DELIVERY SYSTEM (DS) BALLOON BURST, AND THE NOSE CONE AND DISTAL PART OF THE CATHETER SEPARATED AND REMAINED IN THE PATIENT. IT IS REPORTED THE PATIENT WAS DISCHARGED TO HOME AND IS DOING WELL. WHILE TRYING TO RETRIEVE AN EMBOLIZED 29MM SAPIEN XT VALVE THROUGH THE PATIENT¿S PORCELAIN AORTA, THE VALVE COULD NOT BE PULLED BACK THROUGH THE NARROW CALCIFIC DESCENDING AORTA. IN ADDITION, THE VALVE COULD NOT BE DEPLOYED IN THE ASCENDING AORTA AS ITS DIAMETER WAS BIGGER THAN THE VALVE. MANY ATTEMPTS WERE MADE TO SECURE THE VALVE IN THE ASCENDING AORTA BY INFLATING THE DS BALLOON AT SPECIFIC LOCATIONS. AS A RESULT, THE (DS) BALLOON BURST, FORCING THE PHYSICIANS TO RETRACT THE DEVICE. WHILE REMOVING THE NF+ SYSTEM, THE NOW SHRIVELED DS BALLOON CAUGHT ON THE DISTAL PORTION OF THE SLIT ESHEATH. THE DISTAL PORTION OF THE CATHETER, (FROM THE NOSE CONE TO THE VALVE MARKERS, AS WELL AS THE RADIOPAQUE MARKER), DISLODGED AND REMAINED IN THE PATIENT'S ABDOMINAL AORTA WHILE THE REST OF THE SYSTEM WAS RETRACTED. MANY UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE REMAINING PIECES OF THE CATHETER AND RESTORE NORMAL BLOOD FLOW BACK INTO THE ABDOMINAL AORTA. FINALLY, TWO COVERED STENTS WERE DEPLOYED ADJACENT TO THE AREA AND NORMAL BLOOD FLOW WAS OBSERVED. THE NOSE CONE AND DISTAL PORTION OF THE CATHETER WERE LEFT INSIDE THE PATIENT. THE EMBOLIZED VALVE WAS SECURED IN THE AORTIC ARCH USING A BUDDY BALLOONING METHOD. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE ENTIRE PROCEDURE. HE LEFT THE ROOM INTUBATED AND WAS ADMITTED TO THE ICU. THE FOLLOWING MORNING HE WAS EXTUBATED AND NO CVA WAS OBSERVED. HE WAS SITTING UP IN BED TALKING AND 48 HOURS POST PROCEDURE WAS SITTING ON A CHAIR EATING.

    Description of Event or Problem · 1

    AS REPORTED BY OUR (B)(4) AFFILIATES, DURING ATTEMPTS TO SECURE A 29MM SAPIEN VALVE EMBOLIZED, THE DELIVERY SYSTEM (DS) BALLOON BURST, AND THE NOSE CONE AND DISTAL PART OF THE CATHETER (UP TO THE SECOND VALVE MARKER) WAS LEFT IN THE PATIENT. THE PATIENT HAD A PORCELAIN AORTA, SO THE EMBOLIZED VALVE COULD NOT BE PULLED BACK TO THE NARROW CALCIFIC DESCENDING AORTA AND COULD NOT BE DEPLOYED IN THE ASCENDING AORTA, AS ITS DIAMETER WAS BIGGER THAN THE VALVE. MANY ATTEMPTS WERE MADE AT SECURING THE VALVE IN THE ASCENDING AORTA BY INFLATING THE (DS) BALLOON AT SPECIFIC LOCATIONS. THAT IN TURN CAUSED THE DS BALLOON ON THE SYSTEM TO BURST, FORCING THE PHYSICIANS TO RETRACT THE DEVICE. WHILE REMOVING THE NF+ SYSTEM, THE NOW SHRIVELED DS BALLOON STAYED CAUGHT ON THE DISTAL PORTION OF THE SLIT ESHEATH. THE DISTAL PORTION OF THE CATHETER FROM THE NOSE CONE TO THE VALVE MARKERS, AS WELL AS THE RADIOPAQUE MARKER OF THE ESHEATH DISLODGED AND REMAINED IN THE PATIENT'S ABDOMINAL AORTA, WHILE THE REST OF THE SYSTEM WAS RETRACTED. MANY UNSUCCESSFUL ATTEMPTS WERE MADE TO CAPTURE THE REMAINING PIECES AND ALLOW NORMAL BLOOD FLOW BACK INTO THE ABDOMINAL AORTA FINALLY TWO COVERED STENTS WERE DEPLOYED ADJACENT TO THE AREA AND NORMAL BLOOD FLOW WAS OBSERVED. THE NOSE CONE AND DISTAL PART OF THE CATHETER, UP TO THE SECOND VALVE MARKER, AS WELL AS THE MARKER OF THE ESHEATH, WERE LEFT INSIDE THE PATIENT. THE EMBOLIZED VALVE WAS SECURED IN THE AORTIC ARCH USING A BUDDY BALLOONING METHOD. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE ENTIRE PROCEDURE. HE LEFT THE ROOM INTUBATED AND WAS ADMITTED TO THE ICU. THE FOLLOWING MORNING THE PATIENT WAS EXTUBATED AND NO CVA WAS OBSERVED. HE WAS SITTING UP IN BED TALKING AND 48 HOURS POST PROCEDURE WAS SITTING ON A CHAIR EATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623884 EDWARDS EXPANDABLE INTRODUCER SHEATH SET INTRODUCER, CATHETER NPT EDWARDS LIFESCIENCES 920ES29 59775004

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention