BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 11181498 · Received January 15, 2021

    Report

    Report Number
    2025587-2021-00199
    Event Type
    Injury
    Date Received
    January 15, 2021
    Date of Event
    October 21, 2020
    Report Date
    January 25, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED DATA: A4. PATIENT WEIGHT (183 LBS). B5. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN / AUTHOR STATED THAT THE EVOLUT PRO+ VALVE AND THE THREE BAVS ALL CONTRIBUTED TO THE FORMATION OF THE PSEUDOANEURYSM / CONTAINED RUPTURE. D4. EXPIRATION DATE, SERIAL #, AND UNIQUE IDENTIFIER (UDI) #. H4. DEVICE MFG DATE. A SEARCH OF THE MEDTRONIC GLOBAL COMPLAINT HANDLING DATABASE WITH THE PROVIDED UNIQUE DEVICE IDENTIFIER (SERIAL) NUMBER DID NOT FIND AN EXISTING COMPLAINT FILE FOR THESE OBSERVATIONS. 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 · 1

    CITATION: KELLOGG MS ET AL. PERCUTANEOUS MANAGEMENT OF A CONTAINED ANNULAR RUPTURE OCCURRING WITH SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC: CASE REPORTS; OCTOBER 2020; 2(12): 1852-1858. DOI: 10.1016/J.JACCAS.2020.09.007. AVAILABLE ONLINE 21 OCTOBER 2020. 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 CASE REPORT REGARDING A (B)(6)-YEAR-OLD MALE PATIENT WHO PRESENTED WITH GASTROINTESTINAL BLEEDING AND WAS FOUND TO HAVE EVIDENCE OF HEART FAILURE AND SEVERE AORTIC STENOSIS (PEAK/MEAN GRADIENTS OF 125/80 MM HG). FOUR-DIMENSIONAL ELECTROCARDIOGRAM-GATED CARDIAC COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED A MODERATELY CALCIFIED AORTIC ANNULUS, A SEIVERS-1 BICUSPID AORTIC VALVE, AND NO LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION. TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT WAS PERFORMED WITH A 26 MM MEDTRONIC EVOLUT PRO+ (SERIAL NUMBER NOT PROVIDED) AFTER PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH 20- AND 21-MM NON-MEDTRONIC BALLOONS. IMMEDIATELY FOLLOWING VALVE IMPLANT, A RESIDUAL MEAN GRADIENT OF 17 MM HG WAS NOTED, WHICH THE PHYSICIAN/AUTHOR FELT WAS UNACCEPTABLY HIGH, SO A POST-IMPLANT BAV WAS PERFORMED WITH A 22 MM NON-MEDTRONIC BALLOON. AFTERWARD, THE MEAN GRADIENT WAS REDUCED TO 10 MM HG. NO PERICARDIAL EFFUSION WAS OBSERVED; HOWEVER, AORTOGRAPHY DETECTED A CONTAINED AREA OF CONTRAST EXTRAVASATION. THE PATIENT REMAINED ASYMPTOMATIC AND HEMODYNAMICALLY STABLE AND WAS ADMITTED TO THE CARDIAC CARE UNIT. THE PHYSICIAN/AUTHOR NOTED THE DIFFERENTIAL DIAGNOSIS OF CONTRAST EXTRAVASATION FROM THE AORTA OR LVOT TO THE EXTRALUMINAL SPACE IS LIMITED AND INCLUDED CONTAINED OR UNCONTAINED AORTIC ROOT AND LVOT RUPTURE. TWO DAYS FOLLOWING VALVE IMPLANT, A COMPUTED TOMOGRAPHY SCAN REVEALED A 1.1 X 0.8 X 0.7 CM OPACIFIED PSEUDOANEURYSM INFERIOR TO THE RIGHT CORONARY CUSP COMPRESSING THE RIGHT CORONARY ARTERY. SIX DAYS FOLLOWING VALVE IMPLANT, SERIAL COMPUTED TOMOGRAPHY SCAN WAS UNCHANGED, AND THE PATIENT WAS DISCHARGED. TWENTY-THREE DAYS FOLLOWING VALVE IMPLANT, REPEAT COMPUTED TOMOGRAPHY SCAN SHOWED ENLARGEMENT OF THE PSEUDOANEURYSM, BUT THE PATIENT REMAINED ASYMPTOMATIC. SURGICAL REPAIR WAS RECOMMENDED, BUT THE PATIENT DECLINED. THE PHYSICIAN/AUTHOR TEAM PLANNED A PERCUTANEOUS REPAIR WITH SURGICAL BAILOUT IF NECESSARY. FORTY-FIVE DAYS FOLLOWING VALVE IMPLANT, THE PERCUTANEOUS REPAIR WAS PERFORMED. RIGHT CORONARY ARTERY ANGIOGRAPHY EXHIBITED A NEW PROXIMAL STENOSIS FROM EXTRINSIC COMPRESSION; HOWEVER, THE PATIENT REMAINED WITHOUT SIGNS OF ISCHEMIA. SUBSEQUENTLY, A NON-MEDTRONIC NEUROVASCULAR MICROCATHETER WAS ADVANCED INTO THE PSEUDOANEURYSM/CONTAINED RUPTURE AND DELIVERED FOUR COILS INTO THE CONTAINED RUPTURE ¿OUTPOUCHING¿. THEN 0.3 ML OF COPOLYMER GLUE WAS INJECTED. AT THE END OF THE REPAIR, THERE WAS NO EXTRAVASATION OF CONTRAST INTO THE PSEUDOANEURYSM/CONTAINED RUPTURE. TWO MONTHS AFTER THE REPAIR, COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED ABOLITION OF THE PSEUDOANEURYSM/CONTAINED RUPTURE WITHOUT EXTRAVASATION OF CONTRAST, NO PROGRESSION OF EXTRINSIC COMPRESSION TO THE RIGHT CORONARY ARTERY, AND THE PATIENT REMAINED WITHOUT SYMPTOMS OF ISCHEMIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76832 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-26US

    Patients

    Seq Age Sex Outcome Treatment
    1