BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6170878 · Received December 13, 2016

    Report

    Report Number
    2025587-2016-02009
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 20, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00681490265942
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    INVESTIGATION: IT WAS REPORTED THAT FIFTEEN YEARS AND FIVE MONTHS POST IMPLANT OF THIS FREESTYLE BIOPROSTHETIC VALVE, THE VALVE HAD DEVELOPED STENOSIS AND REGURGITATION, AND A VALVE-IN-VALVE REPLACEMENT WAS SUCCESSFULLY PERFORMED. THE PATIENT DIED DURING THE SURGERY DUE TO A RETROPERITONEAL BLEED AND AN ILIAC PERFORATION. AN AUTOPSY INDICATED THAT THE PERFORATION IN THE VENTRICLE WAS ¿SMALL AND UNREMARKABLE¿ AND MAY NOT HAVE CONTRIBUTED TO THE DECREASE IN BLOOD PRESSURE. THE PHYSICIAN SUSPECTED THAT THE SURGICAL ROOT GRAFT HAD BEEN ¿DISRUPTED¿ DURING THE PROCEDURE RESULTING IN INCREASED AORTIC INSUFFICIENCY, CAUSING THE HYPOTENSION, AND WAS POSSIBLY EXACERBATED BY THE DEEP IMPLANT AND/OR THE ATTEMPTS TO IMPLANT THE TRANSCATHETER VALVE. CONCLUSION: SINCE THE FREESTYLE VALVE WAS IMPLANTED FOR OVER FIFTEEN YEARS BEFORE THIS PRODUCT EVENT, IT¿S VERY UNLIKELY THAT THE REPORTED STENOSIS AND REGURGITATION ARE DUE TO ANY POTENTIAL MANUFACTURING ISSUE. BASED ON THE REPORTED INFORMATION THE CAUSE OF DEATH WAS ASCERTAINED TO BE UNRELATED TO THE VALVE OR ITS FUNCTION.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. (B)(4). 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE, INTO A MEDTRONIC AORTIC ROOT GRAFT (IMPLANTED 15 YEARS AND 5 MONTHS PRIOR) WITH SEVERE AORTIC INSUFFICIENCY AND STENOSIS, THE TRANSCATHETER BIOPROSTHETIC VALVE WAS POSITIONED DEEP (APPROX. 15-16MM). WITH THE VALVE DEPLOYED TO 80%, THE LEAFLETS APPEARED TO BE FUNCTIONING PROPERLY, HOWEVER THE PATIENT WAS HYPOTENSIVE. ECHOCARDIOGRAM REVEALED A SMALL LEFT SIDED PERICARDIAL EFFUSION. THE VALVE WAS RE-CAPTURED AND REMOVED FROM THE PATIENT, HOWEVER THE PATIENT REMAINED HYPOTENSIVE. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. AN ATTEMPT WAS MADE TO INSERT AN ARTERIAL CANNULA FOR CARDIOPULMONARY BYPASS, BUT RESISTANCE WAS MET. SHORTLY THEREAFTER, A RETROPERITONEAL BLEED WAS NOTED AND AN ILIAC PERFORATION WAS SUSPECTED. THE CHEST WAS OPENED AND A LEFT VENTRICULAR PERFORATION WAS FOUND. REPAIR WAS ATTEMPTED, HOWEVER THE PATIENT DIED. PER THE PHYSICIAN, THE SUSPECTED CAUSE OF THE PERICARDIAL EFFUSION WAS A NON-MEDTRONIC GUIDEWIRE AND THE SUSPECTED CAUSE OF THE ILIAC ARTERY PERFORATION WAS THE ARTERIAL CANNULA THAT BECAME STUCK ON A KINKED NON-MEDTRONIC GUIDEWIRE. THE MANUFACTURER OF THE CANNULA WAS UNABLE TO BE OBTAINED. AN AUTOPSY INDICATED THAT THE PERFORATION IN THE VENTRICLE WAS ¿SMALL AND UNREMARKABLE¿ AND MAY NOT HAVE CONTRIBUTED TO THE DECREASE IN BLOOD PRESSURE. THE PHYSICIAN SUSPECTED THAT THE SURGICAL ROOT GRAFT HAD BEEN ¿DISRUPTED¿ DURING THE PROCEDURE RESULTING IN INCREASED AORTIC INSUFFICIENCY, CAUSING THE HYPOTENSION, AND WAS POSSIBLY EXACERBATED BY THE DEEP IMPLANT AND/OR THE ATTEMPT TO IMPLANT THE TRANSCATHETER VALVE. IT WAS ALSO REPORTED THAT THERE WAS A SIGNIFICANT BEND WHERE THE AORTIC ROOT GRAFT WAS ATTACHED TO THE AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821310 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION FR995-27 00681490265942

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death MODEL: ENVEOR-US/ LOT NUMBER: 0008179398