BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 17373464 · Received July 21, 2023

    Report

    Report Number
    2025587-2023-02928
    Event Type
    Injury
    Date Received
    July 21, 2023
    Date of Event
    January 9, 2023
    Report Date
    May 2, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000211158
    PMA / PMN Number
    P130021
    Removal / Correction Number
    2025587-12/02/2022-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: PRODUCT ID: D-EVPROP34, SERIAL/LOT #: (B)(6), UBD: 11-OCT-2023, UDI#: (B)(4). CONCOMITANT DEVICE: PRODUCT ID: L-EVPROP34, PRODUCT TYPE: 0195-HEART VALVES; LOT NUMBER: 0011346286; PRODUCT ID: 26MM BALLOON (Z-MED), B. BRAUN INTERVENTIONAL SYSTEMS INC. H6. THE CODES PRESENT IN SECTION H6 CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. CONCLUSION: THE SUBJECT¿S DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED BY THE CUSTOMER AND THEREFORE WAS UNABLE TO BE RETURNED FOR ANALYSIS. THE VALVE REMAINED IMPLANTED. NO PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. THE DEVICE HISTORY REVIEW (DHR) AND FRAME REVIEW OF THE VALVE WERE PERFORMED. ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION AS OUTLINED IN APPLICABLE PROCEDURES AND SPECIFICATIONS. ALL MATERIALS USED WERE AS PER THE REQUIREMENTS OF THE DHR. ALL PROCESSES WERE CARRIED OUT AS PER RELEVANT PROCEDURES AND DEVICE MET SPECIFICATIONS. NO NON-CONFORMING MATERIAL REPORT (NCMR) OR DEVIATIONS REFERENCED ON THE DHR WERE IDENTIFIED. DHR REVIEW DID NOT SHOW ANY DEVIATIONS IN THE MANUFACTURING PROCESS. IT WAS REPORTED THAT, ON THE FIRST DEPLOYMENT ATTEMPT, THE VALVE DISLODGED. POTENTIAL FACTORS THAT COULD INFLUENCE DISLODGEMENT INCLUDE TENSION APPLIED ON THE DCS DURING POSITIONING, CALCIFICATION LEVELS AND SHAPE OF THE NATIVE ANATOMY. IN THIS CASE, THE CAUSE OF THE REPORTED DISLODGEMENT COULD NOT BE CONCLUSIVELY DETERMINED WITH THE INFORMATION AVAILABLE. DISLODGEMENT EVENTS DO NOT TYPICALLY INDICATE A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS. FOLLOWING THE DISLODGEMENT, THE VALVE WAS RECAPTURED. THE SYSTEM WAS REMOVED AND RELOADED WITH THE SAME VALVE AND DCS. THIS SYSTEM WAS RE-INSERTED AND THE VALVE WAS ATTEMPTED TO BE DEPLOYED AGAIN. THE EVOLUT PRO PLUS INSTRUCTIONS FOR USE (IFU) STATES ¿IF A BIOPROSTHESIS AND CATHETER HAVE BEEN REMOVED FROM A PATIENT, DISPOSE OF BOTH THE BIOPROSTHESIS AND CATHETER; DO NOT ATTEMPT TO REUSE EITHER COMPONENT. BOTH THE BIOPROSTHESIS AND CATHETER MUST BE REPLACED WITH NEW STERILE COMPONENTS.' THIS INDICATES OFF-LABEL USE. THE REPORTED EVENT INDICATES THAT FOLLOWING THE RE-INSERTION OF THE CATHETER INTO THE PATIENT, THE VALVE WAS RECAPTURED TWICE FOR AN UNKNOWN REASON. RECAPTURING IS A FEATURE OF THE EVOLUT PRO PLUS SYSTEM THAT ALLOWS FOR ADDITIONAL ATTEMPTS AT ACCURATELY POSITIONING THE VALVE. VARIOUS FACTORS CAN AFFECT VALVE POSITIONING INCLUDING PATIENT ANATOMY OR PHYSICIAN TECHNIQUE. THERE IS NO INFORMATION TO SUGGEST THAT A DEVICE QUALITY DEFICIENCY MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT, BUT THE CAUSE OF THE POSITIONING DIFFICULTY COULD NOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE EVIDENCE. POSITIONING DIFFICULTIES DO NOT TYPICALLY INDICATE A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS. INFOLDING EVENTS ARE TYPICALLY RELATED TO PATIENT ANATOMICAL FACTORS (I.E., CALCIFICATION LEVEL, LVOT ANOMALIES, COMPLIANCE OF THE ANNULUS, BICUSPID VALVE) AND/OR PROCEDURAL FACTORS (I.E., PRE-CASE PLANNING, SIZING, LOADING, USER TECHNIQUE). ADDITIONALLY, THE VALVE FRAME IS CONSTRUCTED WITH NITINOL AND THE LATTICED STRUT DESIGN ALLOWS THE VALVE TO BE COMPRESSED AND LOADED INTO THE DELIVERY SYSTEM. DURING EITHER THE LOADING OR DEPLOYING/RECAPTURING PROCESS, THE STRUTS MAY CROSS OVER AND CATCH ON EACH OTHER WHILE BEING COMPRESSED, AND POTENTIALLY CAUSE INFOLDING. IN THIS CASE, NO ROOT CAUSE CAN BE ASSIGNED WITH THE INFORMATION MADE AVAILABLE. THE VALVE WAS ULTIMATELY IMPLANTED. PARAVALVULAR LEAK (PVL) IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE DEVICE INSTRUCTIONS FOR USE (IFU) AND CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. THE VALVE DISLODGMENT AND INFOLDINGS ARE LIKELY A CONTRIBUTING FACTOR. THE PATIENTS LOW BLOOD PRESSURE WAS TREATED WITH MEDICATION AND THE POST-BAV RESOLVED THE PVL AND INFOLD. THIS REPORT WAS SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00916038. 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.

    Additional Manufacturer Narrative · 0

    PREVIOUS REPORT(S) IN THIS SERIES SHOULD HAVE CONTAINED THE FOLLOWING NARRATIVE TEXT: "THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION FOR CAPA 564121 PER (B)(4)." MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, FLUOROSCOPY CHECK IDENTIFIED THAT NO OVERLAP WAS OBSERVED. THE VALVE WAS SUCCESSFULLY LOADED ON THE FIRST ATTEMPT. NO PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED. THE DELIVERY CATHETER SYSTEM (DCS) WAS INSERTED, ADVANCED, AND THE VALVE WAS PARTIALLY DEPLOYED. THE VALVE OPENED COMPLETELY AND THEN DISLODGED. THE VALVE WAS THEN RECAPTURED. THE SYSTEM WAS REMOVED AND RELOADED WITH THE SAME VALVE AND DCS. THIS SYSTEM WAS RE-INSERTED, AND THE VALVE WAS ATTEMPTED AND RECAPTURED TWO MORE TIMES. AFTER THE VALVE RECAPTURE, AN INFOLD WAS NOTED. PER THE PHYSICIAN, THERE WAS NO CALCIUM IN THE ANNULUS, THEREFORE THE ANATOMY DID NOT CONTRIBUTE TO THE INFOLD. THE TARGET IMPLANT DEPTH WAS 3 MILLIMETERS (MM). THE VALVE WAS ULTIMATELY IMPLANTED AT A FINAL DEPTH OF 5MM ON THE NON-CORONARY CUSP (NCC) AND LEFT CORONARY CUSP (LCC). A TOTAL OF 3 RECAPTURES PRIOR TO THE ULTIMATE VALVE IMPLANT OCCURRED. AS REPORTED, THE VALVE DID NOT OPEN DUE TO AN INFOLD. MODERATE TO SEVERE PARAVALVULAR LEAK (PVL) WAS OBSERVED. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 26M M NON-MEDTRONIC BALLOON (Z-MED) WHICH RESOLVED THE INFOLD. AS REPORTED, THE PATIENT WAS UNSTABLE DURING THE PROCEDURE. THE INSTABILITY WAS DESCRIBED AS LOW BLOOD PRESSURE AND WAS TREATED WITH MEDICATION. THE PATIENT RECOVERED AND WAS DISCHARGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922443 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-34US 00763000211158

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening "SEE H10...."