BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3776153 · Received April 28, 2014

    Report

    Report Number
    2025587-2014-00242
    Event Type
    Death
    Date Received
    April 28, 2014
    Date of Event
    April 2, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, IT WAS REPORTED THAT NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS NOT PROVIDED TO MEDTRONIC. PROCEDURAL IMAGES WERE REQUESTED BUT NOT MADE AVAILABLE. THE ROOT CAUSE OF THIS CLINICAL EVENT COULD NOT BE DETERMINED. 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. THE REPORTED CLINICAL OBSERVATION DID NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. THE PATIENT¿S PHYSICIANS REPORTED THEY DID NOT BELIEVE THERE WAS AN ISSUE WITH THE DEVICE OR THAT IT CAUSED THE PATIENT'S SUBSEQUENT DEATH, AND THAT THE PATIENT HAD A POOR HEART WHICH WAS THE SUSPECTED CAUSE OF DEATH AND THE LATERAL WALL MOVEMENT ISSUE WAS DEEMED TO BE RELATED TO AN INTRAOPERATIVE MYOCARDIAL INFARCTION. HYPOTENSION AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EFFECTS PER THE DEVICE¿S INSTRUCTIONS FOR USE (IFU), AND ARE HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE DATE OF DEATH WAS ESTIMATED BASED ON COMMUNICATION WITH THE FIELD. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC HEART VALVE, BETWEEN ONE-THIRD AND TWO-TH IRDS DEPLOYMENT, THE PATIENT EXHIBITED A DROP IN BLOOD PRESSURE AS EXPECTED; HOWEVER, THE PRESSURE DID NOT RECOVER AT TWO-THIRDS DEPLOYMENT AND THE VALVE WAS QUICKLY DEPLOYED. THE ANESTHETIST ADMINISTERED INOTROPES TO SUPPORT THE BLOOD PRESSURE; HOWEVER, THE BLOOD PRESSURE DID NOT INCREASE AND CHEST COMPRESSIONS WERE STARTED. THE VALVE'S DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED FROM THE PATIENT'S FEMORAL ARTERY AND THE PATIENT WAS PLACED ON FEMORAL-FEMORAL BYPASS. THE PATIENT WAS DEFIBRILLATED FOUR TIMES AND RETURNED TO AN INTRINSIC RHYTHM. LEFT FEMORAL ARTERY ACCESS WAS OBTAINED AND A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY OF THIS VALVE WAS COMPLETED, RESULTING IN MILD IMPROVEMENT TO MODERATE AORTIC INSUFFICIENCY. IT WAS NOTED THAT THE LATERAL WALL OF THE MYOCARDIUM WAS NOT MOVING. THE PATIENT'S PHYSICIANS DETERMINED THAT ANY FURTHER ACTION WOULD BE FUTILE, AND THE CARDIAC SURGEON AND INTERVENTIONAL CARDIOLOGIST AGREED TO STOP FURTHER INTERVENTIONS. THE PATIENT'S FEMORAL ARTERIES WERE CLOSED PER HOSPITAL PROTOCOL AND THE PATIENT'S FAMILY WAS ADVISED THAT THE PATIENT WOULD EXPIRE. THE PHYSICIANS REPORTED THEY DID NOT BELIEVE THERE WAS AN ISSUE WITH THE DEVICE, OR THAT IT CAUSED THE PATIENT'S SUBSEQUENT DEATH, THE PATIENT HAD A POOR HEART WHICH WAS THE SUSPECTED CAUSE OF THEIR DEMISE. ADDITIONAL INFORMATION WAS REQUESTED AS TO THE CAUSE OF DEATH, ANY AUTOPSY RESULTS, OR IF ANY PROCEDURAL IMAGES MAY BE AVAILABLE FOR REVIEW. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254715 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death