BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 11870591 · Received May 24, 2021

    Report

    Report Number
    2025587-2021-01645
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    March 1, 2021
    Report Date
    July 1, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B5. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THERE WERE NO UNEXPECTED ADVERSE EVENTS RELATED TO THE CONTEGRA CONDUITS, AND THE INCIDENCE OF CONDUIT ENDOCARDITIS WAS LOW COMPARED TO OTHER STUDIES. 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 · 1

    CITATION: SAXENA A, ET AL. OUTCOMES FOLLOWING HETEROTOPIC PLACEMENT OF RIGHT VENTRICLE TO PULMONARY ARTERY CONDUITS. WORLD J PEDIATR CONGENIT HEART SURG. 2021 MAR 1;12(2):220-229. DOI: 10.1177/2150135120975769. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE EARLY AND LONG-TERM OUTCOMES OF INITIAL AND SUBSEQUENT RIGHT VENTRICLE-TO-PULMONARY ARTERY (RV-PA) CONDUIT PLACEMENT IN A PEDIATRIC POPULATION. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2004 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 119 PEDIATRIC PATIENTS (PREDOMINANTLY MALE, MEDIAN AGE 6 MONTHS, MEDIAN WEIGHT 6.8 KG). OF THOSE, 17 PATIENTS UNDERWENT RV-PA CONDUIT PLACEMENT WITH THE MEDTRONIC CONTEGRA. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS IN THE STUDY POPULATION, SIX PERIOPERATIVE DEATHS OCCURRED FOLLOWING RV-PA CONDUIT REPLACEMENT WITH AN OVERALL SURVIVAL OF 90% AT TEN-YEAR FOLLOW-UP. NONE OF THE DEATHS WERE ATTRIBUTED TO CONTEGRA. AMONG ALL PATIENTS IN THE STUDY POPULATION, THE MEDIAN TIME TO CONDUIT REPLACEMENT WAS 43.5 MONTHS (RANGE OF 19.3 TO 76.2). SIX CONTEGRA PATIENTS REQUIRED CONDUIT-RELATED REINTERVENTION AND UNDERWENT SURGICAL CONDUIT REPLACEMENT. THE REASONS FOR REPLACEMENT CONSISTED OF ELEVATED GRADIENTS (20 TO 60 MM HG), MILD TO SEVERE (¿FREE¿) REGURGITATION, STRUCTURAL VALVE DYSFUNCTION, RIGHT VENTRICLE DILATION, AND CONDUIT SIZE MISMATCH. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766035 CONTEGRA PULMONARY VALVED CONDUIT PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention