BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHER PULMONARY VALVE

    MDR report key: 10289181 · Received July 17, 2020

    Report

    Report Number
    2025587-2020-02254
    Event Type
    Death
    Date Received
    July 17, 2020
    Date of Event
    July 4, 2020
    Report Date
    December 8, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    UDI-DI
    00643169588196
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE: PRODUCT ID: VALVE PB1016 MELODY TPV 16MM, SERIAL#: (B)(4), UBD: 2021-02-18, UDI#: (B)(4). OUTCOME ATTRIBUTED TO ADVERSE EVENT UPDATED TO INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED THAT CHANGED THE CONTEXT OF THE EVENT. THREE DAYS FOLLOWING THE IMPLANT OF THE VALVE, A CARDIOLOGIST NOTED SEVERE TRICUSPID REGURGITATION AND THE PRESENCE OF THROMBUS WAS REPORTED IN THE VALVE. EIGHT DAYS FOLLOWING VALVE IMPLANT, A SECOND 16MM VALVE WAS IMPLANTED, VALVE-IN-VALVE. FOLLOWING IMPLANT, A TRANSTHORACIC ECHOCARDIOGRAM SHOWED ¿GOOD FUNCTION¿ OF THE VALVE. ONE MONTH, SEVEN DAYS FOLLOWING THE INITIAL VALVE IMPLANT, THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ONE MONTH, THIRTEEN DAYS FOLLOWING THE INITIAL VALVE IMPLANT, AN OPEN-CHEST SURGICAL PROCEDURE WAS PERFORMED AND THE ¿TUBE¿ CONTAINING THE VALVES WAS EXPLANTED FROM THE ANNULUS AND A NON-MEDTRONIC MECHANICAL VALVE WAS IMPLANTED WITH GOOD PROSTHETIC FUNCTION. THE PATIENT WAS REMOVED FROM ECMO. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.  THE TWO MEDTRONIC VALVES WERE NOT A CONTRIBUTING FACTOR TO THE PREVIOUSLY REPORTED BLEEDING OR DEATH. CONCOMITANT PRODUCT ADDED. THE INITIAL REPORTER NOTED THE FACILITY SUBMITTED A USER FACILITY REPORT, BUT THE REPORT # WAS NOT PROVIDED. TYPE OF REPORTABLE EVENT UPDATED TO SERIOUS INJURY. PATIENT CODE, DEVICE CODE, AND EVAL CODE METHOD WERE UPDATED. NEITHER OF THE VALVES WERE RETURNED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. THIS EVENT IS A CONTINUATION OF A PREVIOUSLY REPORTED EVENT VIA REGULATORY REPORT#: 2025587-2020-02245 (SUBMITTED: JULY 16, 2020 AND NOVEMBER 19, 2020). 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE WAS REMOVED DUE TO BLEEDING AND THE PATIENT DIED. THE EXACT CAUSE OF DEATH WAS NOT RECEIVED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. UPDATED DATA: OUTCOMES TO ADVERSE EVENT, TYPE OF REPORTABLE EVENT, EVENT PROBLEM AND EVALUATION CODES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE VALVES. THESE DEVICE WERE MANUFACTURED PER APPROVED AND RELEASED MANUFACTURING PROCESSES AND THE DEVICES MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. WITHOUT THE RETURN OF THE VALVE FOR ANALYSIS, A ROOT CAUSE OF THE REGURGITATION CANNOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE, THE REPORTED THROMBUS COULD HAVE LED TO INCOMPLETE COAPTATION AND BE THE POTENTIAL CAUSE FOR THE REGURGITATION. A NUMBER OF FACTORS CAN AFFECT THE CREATION OF THROMBUS, INCLUDING MEDICATIONS, PERI-PROCEDURAL INJURY, AND PRE-EXISTING PATIENT CONDITIONS, AND ITS PRESENCE AND RATE OF FORMATION IS LARGELY DEPENDENT ON PATIENT CONDITION. BASED ON THE LIMITED INFORMATION AVAILABLE, AN ASSIGNABLE ROOT CAUSE LEADING TO THE THROMBUS COULD NOT BE DETERMINED. BASED ON THE LIMITED RECEIVED INFORMATION, THE FAILURE MODE CANNOT BE DETERMINED. THE MELODY INSTRUCTIONS FOR USE (IFU) STATES ¿THE MELODY¿ TPV IS INDICATED FOR USE IN THE MANAGEMENT OF PEDIATRIC AND ADULT PATIENTS WHO HAVE A CLINICAL INDICATION FOR INTERVENTION ON A DYSFUNCTIONAL RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT OR SURGICAL BIOPROSTHETIC PULMONARY VALVE THAT HAS = MODERATE REGURGITATION, AND/OR A MEAN RVOT GRADIENT =35 MM HG.¿ MEDTRONIC HAS NOT SUBMITTED THE MELODY FOR ANY DESIGN RELATED TESTING FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE TRICUSPID VALVE NOR DOES MEDTRONIC HAVE ANY DATA TO SUPPORT THE USE OF MELODY IN THE TRICUSPID POSITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE IN THE TRICUSPID POSITION, ANOTHER TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE WAS IMPLANTED IN THE SAME POSITION FOR AN UNKNOWN REASON. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752462 MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1016 00643169588196

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death| R