BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3933969 · Received July 15, 2014

    Report

    Report Number
    2025587-2014-00474
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE (OPEN OR CATHETER-BASED) AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER (WITH THE RISK-BENEFIT RATIO IN FAVOR OF IMPLANT OF THE PERCUTANEOUS AORTIC VALVE). A CONDUCTION DISTURBANCE DOES NOT INDICATE A DEVICE MALFUNCTION OR POTENTIAL MANUFACTURING ISSUE. THE DEVICE REMAINS IMPLANTED. (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. A NUMBER OF FACTORS CAN AFFECT THE CREATION OF THROMBUS, INCLUDING MEDICATIONS, PERI-PROCEDURAL INJURY, AND PRE-EXISTING PATIENT CONDITIONS, AND ITS PRESENCE AND RATE OF FORMATION IS LARGELY DEPENDENT ON PATIENT CONDITION. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. A VARIETY OF FACTORS CAN INFLUENCE THE ONSET OF STROKE, INCLUDING PATIENT CONDITION. THE PATIENT HAD A PRE-IMPLANT HISTORY OF A STROKE WHICH IDENTIFIES PATIENT CONDITION AS A POSSIBLE CAUSE. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE. STROKE IS A KNOWN POTENTIAL ADVERSE EFFECT PER COREVALVE INSTRUCTIONS FOR USE (IFU).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT 9.5 MONTHS FOLLOWING IMPLANT THE PATIENT WAS HOSPITALIZED WITH RESPIRATORY FAILURE/PULMONARY CONGESTION. 9 DAYS AFTER BEING HOSPITALIZED, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED TO BE CONGESTIVE HEART FAILURE (CHF)/CARDIOGENIC SHOCK. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NINE DAYS POST-IMPLANT, A COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD REVEALED A LEFT PARIETAL INFARCTION THAT HAD NOT BEEN SEEN ON A CT CONDUCTED FIVE DAYS POST-IMPLANT. THE PATIENT¿S EXISTING MEDICAL REGIMEN WAS CONTINUED WITH NO ADDITIONAL TREATMENT OR INTERVENTION. THE PATIENT FAILED SWALLOW EVALUATIONS AND HAD DIFFICULTY WITH SPEECH. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT HAD A PRE-IMPLANT HISTORY OF A STROKE THAT AFFECTED THE RIGHT SIDE; IT WAS REPORTED THAT THE LEFT PARIETAL INFARCTION WAS POSSIBLY RELATED TO THE VALVE OR PROBABLY RELATED TO THE IMPLANT PROCEDURE/DELIVERY CATHETER SYSTEM. IT ALSO WAS REPORTED THAT A POST-OPERATIVE ECHOCARDIOGRAM SHOWED A MOBILE MASS, SUGGESTIVE OF A THROMBUS, HAD ATTACHED TO THE LEFT APEX. MEDICAL TREATMENT WITH WARFARIN WAS INITIATED. THE THROMBUS ALSO WAS THOUGHT TO BE DEVICE- OR PROCEDURE-RELATED. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED SECOND-DEGREE AV BLOCK WHICH PROGRESSED TO COMPLETE HEART BLOCK REQUIRING TEMPORARY PACING SUPPORT. SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED THE SAME DAY WITH NO ADVERSE PATIENT EFFECTS. IT WAS REPORTED THAT PRIOR TO IMPLANT THE PATIENT HAD A SINUS RHYTHM WITH RIGHT BUNDLE BRANCH BLOCK AND LEFT POSTERIOR FASCICULAR BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411995 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-3143

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Other| R DCS-C4-18FR, 0007068081