BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 2882388 · Received December 20, 2012

    Report

    Report Number
    2025587-2012-00206
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    June 24, 2014
    Report Date
    December 16, 2017
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 5 YEARS POST IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE TYPE I STENT FRACTURES HAVE PROGRESSED TO TYPE II FRACTURES WITH LOSS OF STENT INTEGRITY WITH ADDITIONAL FRACTURES SEEN. A SMALL PORTION OF THE STENT FRACTURE HAS BROKEN FREE BUT REMAINS ATTACHED TO THE VALVE WALL. VALVE REPLACEMENT TO BE SCHEDULED IN THE NEAR FUTURE, BUT REMAINS IMPLANTED AT THIS TIME. NO FURTHER ADVERSE PATIENT EFFECTS REPORTED.(B)(4).

    Additional Manufacturer Narrative · 1

    THIS TRANSCATHETER BIOPROSTHETIC VALVE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NOTE: THE DEVICE WAS RETURNED FOR ANALYSIS AFTER BEING EXPLANTED FROM THE PATIENT AFTER DEATH. IT WAS NOTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE OR PROCEDURE OF THIS DEVICE. PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS RETURNED INSIDE THE PATIENT¿S PULMONARY ARTERY WITH BOTH A PRE-STENT AND ANOTHER BIOPROSTHETIC TRANSCATHETER PULMONARY VALVE INSIDE OF IT. DUE TO THE RETURN CONDITION OF THE DEVICES, THE REPORTED STENT FRACTURE OF THIS FIRST IMPLANTED VALVE COULD NOT BE CONFIRMED. A THIN LAYER OF PANNUS WAS NOTED ON THE PULMONARY ARTERY EXTENDING TO THE INFLOW CROWNS OF ALL DEVICES FUSING ALL DEVICES TOGETHER. A SMALL AMOUNT OF CALCIFICATION WAS NOTED ON THE INFLOW CROWNS. OUTFLOW CROWNS COULD NOT BE ASSESSED DUE TO THE PATIENT¿S TISSUE. RADIOGRAPHY DID NOT REVEAL CALCIFICATION IN THE LEAFLETS. IT COULD NOT BE DETERMINED IF THERE IS PRESENCE OF CALCIFICATION IN THE BODY OF THE VALVE. AN EMBOLIZED STENT FRAGMENT WAS NOTED AT THE OUTFLOW AREA. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT 69 MONTHS POST IMPLANT THE PATIENT SHOWED STENOSIS OF THE PULMONARY ARTERIES AND EXISTING BIOPROSTHETIC VALVE. THE PATIENT HAD RE-DILATION OF THE PULMONARY ARTERIES AND THE FRACTURED TRANSCATHETER WAS COMPRESSED WITH PRE-STENTING AND A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED. THIS IMPLANT GAVE SUCCESSFUL RELIEF OF GRADIENT ISSUES AND RESTORED PULMONARY VALVE FUNCTION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. DATE OF THE INTERVENTION WAS (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE RADIOGRAPHY RESULTS REVEALED A TYPE I STENT FRACTURE WITHOUT LOSS OF STENT INTEGRITY. THE FRACTURE WAS NOTED AT THE MOST PROXIMAL ROW OF THE STENT. THE ISSUE REMAINED UNCHANGED AT THREE YEAR FOLLOW-UP. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB10F18

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Other| R