BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 18736093 · Received February 19, 2024

    Report

    Report Number
    2025587-2024-00985
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    September 14, 2018
    Report Date
    February 29, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID ENVPRO-16; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: DELIVERY CATHETER SYSTEM; IMPLANT DATE NA; EXPLANT DATE NA PRODUCT ID L-ENVPRO-16; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: COMPRESSION LOADING SYSTEM IMPLANT DATE NA; EXPLANT DATE NA ADDITIONAL INFORMATION WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED RELATED TO THE REPORTABLE EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SELECT PATIENT INFORMATION CANNOT BE DOCUMENTED IN THE FILE DUE TO REGIONAL PRIVACY REGULATIONS. H6. THE CODES PRESENT IN SECTION H6 CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ELECTROCARDIOGRAM (ECG) IDENTIFIED A LEFT BUNDLE BRANCH BLOCK (LBBB). FOLLOWING THE IMPLANT PROCEDURE A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) INDICATED TRACE PARAVALVULAR LEAK (PVL) AND TRACE AORTIC REGURGITATION (AR). NO TREATMENT WAS REQUIRED. AN ECG INDICATED THE LBBB AND VENTRICULAR ESCAPE BEATS. MEDICATIONS, EXTERNAL PACING, AND HOSPITALIZATION WERE REQUIRED. THE PHYSICIAN INDICATED THESE RHYTHMS WERE POSSIBLY RELATED TO THE VALVE IMPLANT PROCEDURE AND VALVE ITSELF. FOLLOWING THE VALVE IMPLANT ¿SEVERE¿ DELIRIUM OCCURRED FOLLOWING THE ANESTHESIA. THE PATIENT HAD A POOR GENERAL CONDITION, WAS CONFUSED AND BEDRIDDEN. INCONTINENCE PRESENTED AND THE PATIENT REQUIRED TREATMENT WHICH INCLUDED PARENTERAL NUTRITION, FIXATION, URINARY CATHETER, AND UNSPECIFIED MEDICATION. THESE CONDITIONS PROLONGED HOSPITALIZATION FOLLOWING THE VALVE IMPLANT PROCEDURE. APPROXIMATELY FIVE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ELECTROCARDIOGRAM (ECG) REVEALED SINUS T ACHYCARDIA AND THE RESOLUTION OF THE LBBB AND ESCAPE BEATS. NO FURTHER TREATMENT WAS REQUIRED FOR THE RHYTHM. APPROXIMATELY 7 DAYS FOLLOWING THE VALVE IMPLANT PROCEDURE A URINARY TRACT INFECTION (UTI) WAS IDENTIFIED AND TREATED WITH AN ANTIBIOTIC. THE UTI RESOLVED 9 DAYS LATER. THE PHYSICIAN INDICATED THE UTI WAS POSSIBLY RELATED TO THE VALVE IMPLANT PROCEDURE AND UNRELATED TO THE MEDTRONIC PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED APPROXIMATELY 8 DAYS FOLLOWING THE VALVE IMPLANT PROCEDURE RESPIRATORY INSUFFICIENCY, RESPIRATORY DETERIORATION WITH SUSPICION OF ASPIRATED PNEUMONIA, AND WORSENING CONGESTIVE HEART FAILURE WERE IDENTIFIED. THE RESPIRATORY INSUFFICIENCY AND WORSENING CONGESTIVE HEART FAILURE PROLONGED THE VALVE IMPLANT HOSPITALIZATION. THE RESPIRATORY INSUFFICIENCY REQUIRED NON-INVASIVE UNSPECIFIED VENTILATION AND ANTIBIOTIC MEDICATION ADMINISTRATION. THE CAUSE OF THE RESPIRATORY INSUFFICIENCY WAS NOT REPORTED. HOWEVER, THE PHYSICIAN INDICATED THE RESPIRATORY INSUFFICIENCY WAS NOT RELATED TO THE MEDTRONIC PRODUCTS OR TO THE PROCEDURE. THE RESPIRATORY INSUFFICIENCY RESOLVED 3 DAYS FOLLOWING ONSET. THE RESPIRATORY DETERIORATION WITH SUSPICION OF ASPIRATED PNEUMONIA WAS TREATED WITH AN ANTIBIOTIC. THIS PNEUMONIA WAS REPORTED TO HAVE RESOLVED 8 DAYS FOLLOWING ONSET. THE PHYSICIAN INDICATED THIS SUSPECTED ASPIRATED PNEUMONIA WAS POSSIBLY RELATED TO THE VALVE IMPLANT PROCEDURE AND UNRELATED MEDTRONIC PRODUCTS. THE PLEURAL EFFUSION ASSOCIATED WITH THE WORSENING HEART FAILURE WAS TREATED WITH INTRAVENOUS DIURETIC MEDICATION (1300 MILLILITERS (ML) OF INVASIVE INTERVENTION VIA PUNCTURE) AND A REDUCTION OF A CARDIAC GLYCOSIDE MEDICATION. THE PLEURAL EFFUSION RESOLVED THE SAME DAY BUT HAD ALSO REPORTED TO PROLONG HOSPITALIZATION. THE PHYSICIAN INDICATED THE PLEURAL EFFUSION WAS POSSIBLY RELATED TO THE VALVE IMPLANT PROCEDURE BUT UNRELATED TO THE MEDTRONIC PRODUCTS. THE PHYSICIAN INDICATED THE WORSENING CONGESTIVE HEART FAILURE WAS NOT RELATED TO THE MEDTRONIC PRODUCTS OR TO THE PROCEDURE. THE DELIRIUM CONDITION WAS STILL PRESENT AT DISCHARGE APPROXIMATELY 31 DAYS FOLLOWING THE VALVE IMPLANT. NEUROLOGICAL DEFICITS FOLLOWED BY MULTI-MODAL THERAPY. THE PATIENT WAS RELOCATED TO A REHABILITATION CLINIC AND DISABILITY WAS REPORTED. THE PHYSICIAN INDICATED THIS WAS PROBABLY RELATED TO THE VALVE IMPLANT PROCEDURE. WITH THE REPORTED DELIRIUM AND WORSENING CONGESTIVE HEART FAILURE, AS REPORTED, A DECISION WAS MADE FOR ¿RESTRICTIVE TREATMENT¿ DUE TO THE ¿PURE HEALTH¿ CONDITION OF THE PATIENT. NO FUTURE INVASIVE PROCEDURE, ¿RESTRICTIVE MEDICATION¿, AND NO HOSPI TALIZATION/REHOSPITALIZATION WOULD BE DONE. INFORMATION WAS INITIALLY PROVIDED WHICH INDICATED THAT APPROXIMATELY 7 AND HALF MONTHS LATER THE PATIENT DIED WITH REPORT THE ONGOING NEUROLOGICAL EVENT CONCLUDED WITH A NON-SUDDEN CARDIAC DEATH. THE OFFICIAL CAUSE OF DEATH WAS NOT REPORTED. HOWEVER, THE DEATH INFORMATION WAS LATER REDACTED AND THEREFORE, THE PATIENT OUTCOME WAS UNCLEAR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PATIENT DIED DUE TO EXSICCOSIS. THE PATIENT¿S GENERAL HEALTH CONDITION WORSENED. HOSPITALIZATION OCCURRED DUE TO MULTI-MORBID CONDITIONS. UNSPECIFIED DIAGNOSTIC PROCEDURES PERFORMED WITHOUT DIAGNOSIS. THE PATIENT REFUSED ANY THERAPY NOR INCLUSIVE NUTRITION. THE PHYSICIAN INDICATED THE DEATH WAS NOT SOLELY CAUSED BY THE PATIENT¿S UNDERLYING, PRE-EXISTING MEDICAL CONDITIONS. ADDITIONALLY, THE PHYSICIAN REPORTED THE DEATH WAS NOT RELATED TO THE DEVICE AND THAT THE VALVE NOR THE VALVE IMPLANT PROCEDURE CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397306 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| H| S "SEE H11...."