BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3041766 · Received April 8, 2013

    Report

    Report Number
    2025587-2013-00054
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 4, 2013
    Report Date
    May 1, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: FOLLOWING THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, CINE IMAGES WERE RECEIVED AT MEDTRONIC AND REVIEWED BY A THIRD PARTY. A REVIEW OF THE IMAGES NOTED THAT WHEN EXPANDING THE VALVE WITH THE ENSEMBLE DELIVERY SYSTEM (DS) THERE WAS AN OBVIOUS WAIST ON THE BALLOON, INDICATING THAT THE BALLOON HAD BEEN INFLATED BEYOND ANATOMIC CONSTRAINTS. IT WAS UNKNOWN WHAT PRESSURE WAS GENERATED WITH OUTER BALLOON EXPANSION (OR IF THE CUSTOMER USED A SYRINGE). IT WAS ALSO NOTED THAT POSITIONING OF THE VALVE WAS A BIT LOW WITHIN THE STENT COMPLEX. THERE WAS ROUGHLY ONE ROW OF STRUTS BEYOND THE WAIST. ALSO, THE INNER DIAMETER (ID) OF THIS COMPLEX WAS WELL BELOW 22MM. THE VALVE WAS OBSERVED TO REMAIN IN PLACE IMMEDIATELY POST IMPLANT. BASED ON THE RELATIVELY SMALL ID AND IMPERFECT POSITION OF THE VALVE, IT WAS LIKELY THAT THE PHYSICIAN DID NOT COMPLETELY DEFLATE ONE OF THE DELIVERY SYSTEM BALLOONS AND/OR THE DEFLATED BALLOON MATERIAL OR CARROT OF THE DS DRAGGED THE VALVE A BIT MORE PROXIMALLY, JUST ENOUGH TO DISLODGE IT COMPLETELY WHEN REMOVING THE DS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN USED A SYRINGE TO INFLATE THE BALLOON WITHOUT DIFFICULTY. THE MEDTRONIC REPRESENTATIVE SUGGESTED TO THE PHYSICIAN THAT MAYBE THE BALLOON WAS NOT INFLATED HIGH ENOUGH (TO ITS NOMINAL PRESSURE) WITH THE SYRINGE AND THAT AN INFLATION DEVICE WOULD ACHIEVE BETTER RESULTS. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS ALWAYS CAREFUL ON REMOVING THE DS; THERE WAS NO DISLODGEMENT OF THE STENT DURING REMOVAL OF DS. THE DS BALLOONS WERE COMPLETELY DEFLATED PRIOR TO REMOVAL. THE DS WAS REMOVED UNDER FLUOROSCOPY AND NO PROBLEMS WERE SEEN AT THIS POINT. CONCLUSION: FROM THE AVAILABLE INFORMATION, A CONCLUSIVE CAUSE OF THE REPORTED MIGRATION OF THE VALVE INTO THE RIGHT VENTRICLE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE VALVE REMAINS IMPLANTED AND THEREFORE WAS NOT RETURNED TO MEDTRONIC FOR ANALYSIS. THE BALLOON FROM THE FIRST DELIVERY SYSTEM WAS DISCARDED AT THE FACILITY. CINE IMAGES FROM THE IMPLANT PROCEDURE HAVE BEEN REQUESTED BUT NOT RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS 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. SHOULD THE CINE IMAGES BE RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).

    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 INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A CONDUIT (PRE-STENTED WITH 39MM <(>&<)> 45MM STENTS ON 22MM BALLOON), THE DELIVERY SYSTEM (DS) BALLOON WAS REMOVED WITH NO RESISTANCE. SUBSEQUENTLY, AN INJECTION OF CONTRAST REVEALED THE VALVE HAD MIGRATED INTO TO THE RIGHT VENTRICLE. THE VALVE REMAINED ON THE WIRE OF THE PRE-STENT WITHIN THE CONDUIT. AFTER SEVERAL ATTEMPTS TO RETRIEVE THE VALVE BACK INTO THE PRE-STENTS IT WAS DECIDED TO PLACE THE VALVE INTO THE INFERIOR VENA CAVA. THE VALVE WAS STENTED OPEN WITH A 28MM STENT ON A 22MM BALLOON WITH SUCCESS. ANOTHER TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED INTO THE CONDUIT WITHOUT DIFFICULTY. THE PHYSICIAN FELT THE DS BALLOON MAY NOT HAVE EXPANDED COMPLETELY, ALTHOUGH IT WAS NOTED THAT THE BALLOON EXPANDED WITHOUT DIFFICULTY DURING PRE-IMPLANT TESTING. IT WAS ALSO NOTED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE SYRINGE. THERE WERE NO ISSUES WITH THE SECOND DS USED TO IMPLANT THE SECOND VALVE (SAME LOT NUMBER AS THE FIRST DS). THE BALLOON FROM THE FIRST DS WAS DISCARDED AT THE FACILITY. NO ADVERSE PATIENT EFFECTS OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142736 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention NU1022, UNKNOWN LOT NUMBER