BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 3941017 · Received July 17, 2014

    Report

    Report Number
    2025587-2014-00484
    Event Type
    Death
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    December 19, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. THE DEVICE REMAINS IMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WENT INTO CARDIOGENIC SHOCK ONE DAY POSTOPERATIVE OF THE ATTEMPT TO SNARE THE TRANSCATHETER VALVE UP INTO THE SINO-TUBULAR JUNCTION WITHOUT SUCCESS. TWENTY DAYS POST-REINTERVENTION ATTEMPT THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK. NO AUTOPSY WAS PERFORMED AND THE DEVICE REMAINS IMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 22 DAYS POST IMPLANT THE PATIENT WAS NOTED TO HAVE ACUTE HYPOXIC RESPIRATORY FAILURE WITH SHORTNESS OF BREATH. PULMONARY EDEMA WAS NOTED ON X-RAY. THE PATIENT WAS TREATED WITH DIURETICS. THE DIURESIS WAS NOT SUCCESSFUL AND THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR FURTHER MANAGEMENT. THE NEXT DAY, THE PATIENT'S OXYGEN SATURATION DECREASED INTO THE 60% RANGE WHILE ON A 50% VENTI-MASK. THE PATIENT CONTINUED TO BE TREATED WITH MEDICATION AND WAS MONITORED. FIVE DAYS LATER, SEVERE PARAVALVULAR LEAK (PVL) WAS NOTED ON ECHOCARDIOGRAM AND CARDIAC CATHETERIZATION. THE PATIENT EXHIBITED SEVERE HYPOTENSIVE (64/34), AND LEVOPHED WAS GIVEN. THE PATIENT SUBSEQUENTLY ALSO HAD A BLOOD TRANSFUSION. THE DECISION WAS MADE TO ATTEMPT TO SNARE (RE-POSITION) THE VALVE UP TO DECREASE THE AMOUNT OF PVL (THE VALVE WAS IMPLANTED SLIGHTLY DEEP). THE SNARE PROCEDURE WAS ATTEMPTED HOWEVER THE DEVICE DISLODGED INTO THE SINO-TUBULAR JUNCTION ABOVE CORONARY ARTERIES. UPON ASSESSMENT POST DISLODGEMENT, THE NATIVE VALVE WAS FUNCTIONING WELL WITH A GRADIENT OF 6 MM AND TRACE TO MILD AORTIC REGURGITATION. THE PHYSICIANS DECIDED TO END THE PROCEDURE. THE PATIENT REMAINED IN THE HOSPITAL FOR MONITORING AND HAS SINCE STABILIZED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. 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

    THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. CONDUCTION DISTURBANCES SUCH AS COMPLETE HEART BLOCK ARE KNOWN POTENTIAL ADVERSE EFFECTS PER THE VALVE INSTRUCTIONS FOR USE, AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER WITH THE RISK-BENEFIT RATIO IN FAVOR OF THE PERCUTANEOUS AORTIC VALVE (PAV) AS WAS THE CASE IN THIS EVENT. THE RELATIONSHIP OF THE CONGESTIVE HEART FAILURE AND THE VALVE COULD NOT BE DETERMINED BUT LIKELY THE HEART FAILURE IS RELATED TO PATIENT CONDITION. PULMONARY EDEMA IS A KNOWN EFFECT PER THE DEVICE INSTRUCTIONS FOR USE, THAT CAN OCCUR AFTER CARDIAC PROCEDURES, BUT A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. IN THIS CASE, THE ISSUE WAS RESOLVED USING A MEDICATION. PARAVALVULAR LEAK CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT, IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. ATRIAL FIBRILLATION IS GENERALLY A RESULT OF KNOWN POTENTIAL ADVERSE EFFECTS, SUCH AS CONDUCTION DISTURBANCES OR HYPERTENSION, OR AN EFFECT OF CERTAIN MEDICATIONS OR OTHER PRE-EXISTING PATIENT CONDITIONS. IT IS A POTENTIAL PROCEDURAL COMPLICATION ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE, OPEN OR CATHETER-BASED, AND CAN OFTEN BE TREATED WITH MEDICATION AS WAS THE CASE IN THIS EVENT. IT IS UNKNOWN IF THE REPORTED BLOOD TRANSFUSION THAT THE PATIENT REPORTEDLY WAS GIVEN WAS DUE TO ANEMIA OR BLEEDING DURING THE PROCEDURE. BOTH BLEEDING AND ANEMIA ARE KNOWN POTENTIAL ADVERSE EFFECT AND CAN OCCUR DURING THE IMPLANT PROCEDURE, WITH A VARYING RISK THAT IS DEPENDENT ON SEVERAL FACTORS SUCH AS THE ACCESS POINT FOR THE IMPLANT, THE PATIENT'S STATE OF HEALTH, AND PRE-EXISTING MEDICAL CONDITIONS. THE ISSUE IS COMMONLY RESOLVED THROUGH A BLOOD TRANSFUSION OR PROVISION OF PACKED RED BLOOD CELLS AS WAS THE CASE IN THIS EVENT. THE REPORT OF DEATH AT SIX WEEKS POST-IMPLANT WAS ASCERTAINED TO BE DUE TO CARDIOGENIC SHOCK. IT IS UNKNOWN IF THE DEVICE OR PROCEDURE CONTRIBUTED TO THE PATIENT DEATH, AND DETAILED INFORMATION ABOUT THE EVENT WAS NOT AVAILABLE AS NO EXPLANT OR AUTOPSY WAS PERFORMED. WITH THE LIMITED INFORMATION AVAILABLE, NO CONCLUSIVE ASSESSMENT COULD BE MADE REGARDING THE RELATIONSHIP OF THE DEVICE TO THE PATIENT DEATH. THE DEVICE HISTORY RECORDS WERE REVIEWED. THE DEVICE WAS BUILT TO SPECIFICATION AND MET ALL INSPECTION AND ACCEPTANCE CRITERIA. NO ISSUES WERE NOTED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED COMPLETE HEART BLOCK (CHB). SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATES THAT THE PATIENT WENT INTO CARDIOGENIC SHOCK ONE DAY POSTOPERATIVE OF THE ATTEMPT TO SNARE THE TRANSCATHETER VALVE UP INTO THE SINO-TUBULAR JUNCTION WITHOUT SUCCESS. TWENTY DAYS POST-REINTERVENTION ATTEMPT THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK. NO AUTOPSY WAS PERFORMED AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419108 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death| R