BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 2080292 · Received March 30, 2011

    Report

    Report Number
    2025587-2011-00033
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    October 28, 2010
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)94). EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY REVIEW WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPEC FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IT WAS REPORTED THAT THE STENT APPEARED TO BE STABLE AND THAT THE PLAN IS TO FOLLOW THE PT, AS THE PT IS NOT SYMPTOMATIC AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT 4 YEARS AND 3 MONTHS FOLLOWING IMPLANT, THE VALVE WAS EXPLANTED DUE TO COMPRESSION AND STENOSIS OF THE VALVE. ADDITIONAL INFORMATION AND RETURN OF THE DEVICE HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHETIC VALVE, IMPLANTED FOR SIX MONTHS IN A 16 YEAR OLD PT, EXHIBITED SIGNS OF STRUCTURAL DAMAGE. THE PT UNDERWENT A ROUTINE POSTOPERATIVE FLUOROSCOPY SIX MONTHS FOLLOWING IMPLANT AND IT WAS NOTED ON DIGITAL IMAGING OF THE STENT IN SEVERAL VIEWS, THAT THERE WAS A SLIGHT ANTERO-POSTERIOR (AP) INTERMITTENT DIMENSION CHANGE WITH HEART MOTION. AT LEAST TWO FRAME FRACTURES WERE IDENTIFIED. AP DIMENSIONS WERE DIMINISHED TO 10-13 MM. IT WAS REPORTED THAT THE STENT APPEARED TO BE STABLE. ADD'L INFO WAS RECEIVED THAT THE PLAN IS TO FOLLOW THE PT, AS THEY ARE NOT SYMPTOMATIC AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES, INC. PB1018 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R