BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVEO PRO DELIVERY SYSTEM

    MDR report key: 8940061 · Received August 28, 2019

    Report

    Report Number
    2025587-2019-02671
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 16, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00643169987203
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVAL CODE METHOD: 10 REPLACED OBSOLETE 4118 EVAL CODE-RESULT: 321, 3251 AND 3252 REPLACED OBSOLETE 3233. PRODUCT ANALYSIS: PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE DELIVERY CATHETER SYSTEM (DCS) WAS RECEIVED WITH THE FRONT GRIP COMPONENTS DETACHED FROM THE HANDLE. THE DEPLOYMENT KNOB APPEARED TO RETRACT AND ADVANCE THE CAPSULE. THE TRIGGER MOVED TO FULLY ADVANCED AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. THE TIP-RETRIEVAL MECHANISM APPEARED INTACT. THERE WAS DAMAGE OBSERVED ON THE THREADING OF THE SCREW GEAR. THE DEVICE WAS RETURNED WITH THE END CAP/SCREW GEAR SNAP FIT CONNECTED. DELAMINATION WAS OBSERVED OVER THE NITINOL REINFORCING FRAME AT THE PROXIMAL END OF THE CAPSULE. THE INNER MEMBER SHAFT AND SPINDLE HUB APPEARED INTACT WITH NO EVIDENCE OF DAMAGE. DAMAGE WAS OBSERVED ON ONE OF THE TABS OF THE FRONT GRIP COMPONENT. CONCLUSION: THE INVESTIGATION IS ANTICIPATED AND HAS NOT YET BEGUN. 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

    CONCLUSION: IT WAS REPORTED THAT THE CAPSULE WAS RECAPTURED TWICE. THE REASON FOR THE RECAPTURE WAS NOT REPORTED. RECAPTURING IS A FEATURE OF THE EVOLUT SYSTEM THAT ALLOWS FOR ADDITIONAL ATTEMPTS AT ACCURATELY POSITIONING THE VALVE. VARIOUS FACTORS CAN AFFECT VALVE POSITIONING INCLUDING PATIENT ANATOMY OR PHYSICIAN TECHNIQUE, BUT THE CAUSE OF THE POTENTIAL POSITIONING DIFFICULTY IN THIS CASE COULD NOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. POSITIONING DIFFICULTIES DO NOT TYPICALLY INDICATE A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS. AFTER THE SECOND RECAPTURE, A CAPSULE BUCKLE WAS OBSERVED. NO PROCEDURAL FILMS WERE RECEIVED FOR REVIEW. 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 DELIVERY CATHETER SYSTEM (DCS) WAS RETURNED FOR ANALYSIS. THE CARTON BOX WAS OBSERVED TO BE DAMAGED, WHICH MOST LIKELY OCCURRED DURING RETURN TRANSPORT FOR ANALYSIS. THE DEVICE WAS RECEIVED WITH THE FRONT GRIP COMPONENTS DETACHED FROM THE HANDLE AND DAMAGE WAS NOTED ON THE SNAP FIT TABS OF THE COMPONENT. THE DESCRIPTION OF THE EVENT DOES NOT INDICATE THAT THE FRONT GRIP SEPARATION OCCURRED DURING THE REPORTED ISSUE, AND THE CAUSE OF THIS DAMAGE CANNOT BE DETERMINED. THE FRONT GRIP SEPARATION MAY HAVE OCCURRED DURING RETURN TRANSPORT FOR ANALYSIS. DELAMINATION WAS OBSERVED ON THE CAPSULE, WHICH TYPICALLY OCCURS WHEN THE CAPSULE IS SUBJECTED TO A BENDING FORCE POTENTIALLY AFTER TRACKING THROUGH PATIENT ANATOMY OR IF THE VALVE HAS BEEN MISLOADED. THE DEPLOYMENT KNOB RETRACTED AND ADVANCED THE CAPSULE WITH NO ISSUES NOTED. EVIDENCE OF A CAPSULE BUCKLE WAS OBSERVED AT THE PROXIMAL END OF THE CAPSULE. CAPSULE BUCKLE CAN OCCUR DUE TO EXCESSIVE COMPRESSIVE FORCES APPLIED TO THE CAPSULE. FORCES IN THE SYSTEM IS A CUMULATIVE EFFECT THAT MAY BE INCREASED BY FACTORS SUCH AS TORTUOUS ANATOMY AND LOAD QUALITY. NO PROCEDURAL IMAGES OR FLUOROSCOPIC LOAD CHECK IMAGES WERE SUBMITTED FOR REVIEW. THE CAUSE OF THE CAPSULE BUCKLE CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. CONCLUSION: THE INVESTIGATION IS ANTICIPATED AND HAS NOT YET BEGUN. 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 THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS RECAPTURED TWO TIMES THEN A BUCKLE OF THE CAPSULE OF THE DELIVERY CATHETER SYSTEM WAS OBSERVED. DIFFICULTY RECAPTURING THE VALVE WAS REPORTED. THE PATIENT'S ANATOMY WAS NOT TORTUOUS, AND CALCIFICATION WAS REPORTED IN THE FEMORAL ARTERY AND SOME CALCIFICATION AT THE LEVEL OF THE SINOTUBULAR JUNCTION (STJ). THE VALVE AND DCS WERE RECOVERED FROM THE PATIENT AND A NEW VALVE AND NEW CATHETER WERE USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736613 ENVEO PRO DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVPRO-14-US 0009381757 00643169987203

    Patients

    Seq Age Sex Outcome Treatment
    1