BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 5064738 · Received September 9, 2015

    Report

    Report Number
    2025587-2015-00952
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    August 19, 2015
    Report Date
    January 26, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. WITHOUT RETURN OF THE DEVICE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED. THE PATIENT¿S WEIGHT WAS REQUESTED BUT UNABLE TO BE OBTAINED. A SUPPLEMENTAL REPORT WILL BE FILED IF THE DEVICE IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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. DIFFICULTIES ADVANCING THE DCS SYSTEM IN THE PATIENT ANATOMY HAVE HISTORICALLY BEEN RELATED TO FACTORS SUCH AS THE PATIENT ANATOMY AND THE PHYSICIAN TECHNIQUE. THE PATIENT¿S CT SUMMARY AND IMAGES OF THE PROCEDURE WERE RECEIVED, WHICH INDICATES THAT THE ANGLE OF THE ASCENDING AORTA AND IMPLANTED SURGICAL AORTIC VALVE CREATED A TURN THAT THE LOADED CAPSULE WAS UNABLE TO TRAVERSE ON ITS OWN. THE ENVEOR DCS CAPSULE WAS PURPOSEFULLY DESIGNED TO BE MORE RIGID THAN THE PREDICATE DEVICE, AS THIS ALLOWS FOR THE DEVICE TO BE INSERTED WITHOUT THE USE OF AN EXTERNAL INTRODUCER SHEATH, AND FOR THE VALVE TO BE RECAPTURED AND REPOSITIONED, POTENTIALLY REDUCING THE NUMBER OF CORONARY OCCLUSIONS AND OTHER ADVERSE PATIENT EFFECTS RELATED TO A MALPOSITIONED DEVICE. HOWEVER, THE RIGIDITY OF THE CAPSULE MAY IMPACT MANEUVERABILITY IN SOME PATIENT ANATOMIES. IN THIS CASE, PERIPHERAL DEVICES SUCH AS STIFF WIRES AND A BALLOON WERE USED TO CHANGE THE ANGLE AND ALLOW THE DCS TO PASS THROUGH THE FRAME. POST IMPLANT, BLOOD WAS NOTED IN THE PLEURAL CAVITY, AND IT WAS DETERMINED THAT THE RUPTURE OF A CHRONIC (>14 DAYS OLD) DISSECTION HAD OCCURRED, LEADING TO PATIENT DEATH. ALTHOUGH A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME, THE RUPTURE IS LIKELY RELATED TO THE DIFFICULTY OF MANEUVERING THE MORE RIGID CAPSULE OF ENVEOR DCS IN TORTUOUS AND/OR HIGHLY CALCIFIED PATIENT ANATOMY, DUE TO THE NEED FOR ADDITIONAL MANIPULATION. THE POSSIBLE SOURCES OF THE INJURY INCLUDE THE NON-MEDTRONIC ¿BUDDY¿ BALLOON, AND ADDITIONAL WIRES THAT WERE INSERTED TO ASSIST WITH ADVANCEMENT.

    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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A NON-MEDTRONIC SURGICAL AORTIC VALVE, THERE WAS DIFFICULTY PASSING THIS DELIVERY CATHETER SYSTEM (DCS) THROUGH THE FRAME OF THE SURGICAL VALVE DUE TO THE ANGLE OF THE AORTIC ROOT AND A DILATED ASCENDING AORTA. MULTIPLE STIFF WIRES WERE USED TO ADVANCE THE DCS, ALSO A 'BUDDY BALLOON" WAS INFLATED TO CHANGE THE ANGLE OF THE DCS AND ALLOW IT TO PASS THROUGH THE SURGICAL VALVE FRAME. THE DCS WAS ADVANCED INTO THE PROPER POSITION AND THE VALVE WAS DELIVERED. AFTER THE VALVE HAD BEEN DEPLOYED, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED A DISSECTION IN THE PROXIMAL DESCENDING AORTA. THE PHYSICIAN REPORTED THAT THE DISSECTION WAS CHRONIC AS THE FLAP WAS THICKENED AND NOT MOBILE. THAT EVENING, BLOOD WAS NOTED IN THE PLEURAL CAVITY REQUIRING SURGICAL INTERVENTION TO DRAIN. A RUPTURED AORTIC DISSECTION IN THE PROXIMAL DESCENDING AORTA WAS REVEALED AND THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596050 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-US 0007606130

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death