BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9462273 · Received December 12, 2019

    Report

    Report Number
    2015691-2019-04639
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    May 4, 2012
    Report Date
    November 28, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE WAS SUBMITTED FOR PUBLICATION ON (B)(6) 2012. THEREFORE, THE 'SUBMISSION FOR PUBLICATION DATE' WAS USED AS THE OCCURRENCE DATE. REFERENCE ARTICLE: NOMBELA-FRANCO, LUIS, JAVIER GOICOLEA, AND JUAN F. OTEO. "PERI-AORTIC HEMATOMA COMPLICATED WITH AORTIC REGURGITATION FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION: DESCRIPTION OF A NOVEL MECHANISM OF PARAVALVULAR LEAK." J INVASIVE CARDIOL 24 (2012): 463-464. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE PATIENT SCREENING MANUAL AND THE PROCEDURE DIDACTIC IDENTIFY SEVERAL PROCEDURAL AND ANATOMICAL FACTORS WHICH COULD CONTRIBUTE TO PVL, INCLUDING DEVICE MALPOSITION, INACCURATE MEASUREMENT OF THE NATIVE VALVE ANNULUS, UNEVEN DISTRIBUTION OF CALCIUM ON THE NATIVE VALVE, BULKY OR SEVERE CALCIFICATION, AN ELLIPTICAL ANNULUS SHAPE AND VALVE UNDER-SIZING. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. THE PATIENT SCREENING MANUAL INSTRUCTS THE OPERATOR ON PROPER AORTIC VALVE AND ROOT ASSESSMENT, INCLUDING THE USE OF ECHO, AORTOGRAM AND CT TO APPROPRIATELY MEASURE THE ANNULUS DIAMETER, CONTENT AND DISTRIBUTION OF CALCIUM, AND LEAFLET CHARACTERISTICS. CONTRAINDICATIONS, IMPORTANT CONSIDERATIONS WHEN ASSESSING THE VALVE, AND CHOOSING THE PROPER THV ARE ALSO DISCUSSED. THE THV TRAINING MANUALS ALSO INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES ARE ALSO INCLUDED. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. PER THE AUTHOR OF THE ARTICLE, ADVANCED AGE, FEMALE GENDER, BULKY-CALCIFIED AORTIC CUSPS THAT PUSHED AGAINST A SMALL SINUS OF VALSALVA, AND SIGNIFICANT BASAL SEPTAL HYPERTROPHY MIGHT LEAD TO EXCESSIVE PRESSURE TO THE POSTERIOR AORTIC ROOT WHERE THE HEMATOMA WAS INITIALLY SEEN. ALSO, OVERSIZING AORTIC ANNULUS MAY HAVE LEAD TO AORTIC TRAUMA. ANY OF THESE FACTORS ALONE OR IN COMBINATION MAY HAVE CONTRIBUTED TO THE EVENTS. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY AN EDWARDS LIFESCIENCES AFFILIATE IN (B)(6), THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿¿PERI-AORTIC HEMATOMA COMPLICATED WITH AORTIC REGURGITATION FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION: DESCRIPTION OF A NOVEL MECHANISM OF PARAVALVULAR LEAK¿, THE FOLLOWING EVENT WAS DETERMINED TO BE RELATED TO AN EDWARDS LIFESCIENCES DEVICE: A CASE OF A (B)(6)-YEAR-OLD-FEMALE PATIENT WITH NEW ONSET HEART FAILURE AND SEVERE AORTIC STENOSIS, UNDERWENT TAVI WITH A 23MM EDWARDS SAPIEN VALVE BY TRANSFEMORAL APPROACH. BALLOON VALVULOPLASTY WAS PERFORMED FIRST WITHOUT ANY COMPLICATIONS AND THE HEART VALVE WAS DEPLOYED. TEE IMAGING SUBSEQUENTLY REVEALED A POSTERIOR PERI-AORTIC HEMATOMA. BY THE END OF THE STUDY, THE HEMATOMA REMAINED STABLE WITH NO FLOW OUTSIDE THE AORTA BY DOPPLER IMAGES AND NO NOTED PERICARDIAL EFFUSION. A REPEAT TTE ON POD2 SHOWED REABSORPTION OF THE PERI-AORTIC HEMATOMA AND A MILD TO MODERATE PV-LEAK. THE PATIENT WAS DISCHARGED HOME CLINICALLY STABLE ON POD5. THE PATIENT RETURNED WITH RECURRENT HEART FAILURE SYMPTOMS ONE WEEK LATER. TTE AND TEE SHOWED A WORSENING OF THE PARAVALVULAR AORTIC REGURGITATION (PAR) FROM MODERATE TO SEVERE. THE PATIENT WAS AGAIN DISCHARGED WITH MEDICAL TREATMENT AND FOLLOWED UP IN THE OUTPATIENT CLINIC AT ONE MONTH POST TAVI. THERE WAS NO DYSPNEA OR DPN AT THAT TIME. ONE MONTH LATER, SHE WAS RE-ADMITTED WITH MINIMAL EXERTIONAL DYSPNEA AND NEW-ONSET ATRIAL FIBRILLATION. DURING THE HOSPITALIZATION, 2 CONSECUTIVE BALLOON POST-DILATIONS (BPD) WERE PERFORMED WITH NO IMPROVEMENT IN PAR GRADE. NONETHELESS, THE PATIENT WAS DEEMED STABLE ENOUGH FOR DISCHARGE WITH MEDICAL MANAGEMENT AND REMAINED STABLE DURING THE FOLLOWING 6 MONTHS. AS PER THE AUTHORS' OPINION, THE ADVANCED AGE, FEMALE GENDER, BULKY-CALCIFIED AORTIC CUSPS THAT PUSHED AGAINST A SMALL SINUS OF VALSALVA, AND SIGNIFICANT BASAL SEPTAL HYPERTROPHY MIGHT LEAD TO EXCESSIVE PRESSURE TO THE POSTERIOR AORTIC ROOT WHERE THE HEMATOMA WAS INITIALLY SEEN. THE ARTICLE ALSO STATED THAT WHILE OVERSIZING AORTIC ANNULUS MIGHT LEAD TO AORTIC TRAUMA, VALVE SIZE IS SYSTEMATICALLY OVERSIZED BY 2 TO 5 MM WITH RESPECT TO THE DIAMETER OF THE AORTIC ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257830 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention