BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9462254 · Received December 12, 2019

    Report

    Report Number
    2015691-2019-04637
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    January 1, 2011
    Report Date
    November 26, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PUBLISHED IN 2011. FOR THIS REASON, THE (B)(6) 2011 WAS USED AS THE OCCURRENCE DATE. REFERENCE THE ARTICLE: RAFFA, GIUSEPPE M., ET AL. "AORTIC VALVE REPLACEMENT FOR PARAPROSTHETIC LEAK AFTER TRANSCATHETER IMPLANTATION." JOURNAL OF CARDIAC SURGERY 27.1 (2012): 47-51. PER THE INSTRUCTIONS FOR USE (IFU), PARAVALVULAR LEAK (PVL) IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH BIOPROSTHETIC HEART VALVES. PARAVALVULAR LEAK REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE STRUCTURE OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE, AS A RESULT OF A LACK OF APPROPRIATE SEALING OF THE VALVE TO THE TARGET SITE. SOME PVL IS NOT UNCOMMON POST DEPLOYMENT. MANY CASES ARE MILD TO MODERATE, AND EITHER RESOLVE OVER TIME OR DO NOT CAUSE SYMPTOMS. OTHERS MAY BE MORE CLINICALLY SIGNIFICANT AND REQUIRE INTERVENTION. THE MECHANISM BEHIND WORSENING OR LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE THE CAUSE OF THE PVL IS UNKNOWN; HOWEVER, THE ARTICLE REPORTS ¿UNEQUAL DISTRIBUTION OF AORTIC VALVE CALCIFICATION AND INCOMPLETE PROSTHESIS APPOSITION TO THE NATIVE NONCORONARY ANNULUS¿ THAT LIKELY CONTRIBUTED TO THE EVENT. 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 THROUGH AN EDWARDS LIFESCIENCES AFFILIATE IN ITALY, THROUGH THE REVIEW OF THE MEDICAL ARTICLE: " AORTIC VALVE REPLACEMENT FOR PARAPROSTHETIC LEAK AFTER TRANSCATHETER IMPLANTATION" THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO EDWARDS DEVICES: A 26MM EDWARDS SAPIEN VALVE WAS IMPLANTED. TEE PERFORMED AFTER THE PROCEDURE AND ON THE FOURTH POSTOPERATIVE DAY SHOWED 1-2+ PARAPROSTHETIC AORTIC REGURGITATION (PVL). ON THE 25TH POD, TEE SHOWED SEVERE PARAPROSTHETIC AORTIC REGURGITATION (3-4+) WITH SEVERE IMPAIRMENT OF LV FUNCTION. THE PATIENT UNDERWENT AN UNSUCCESSFUL ATTEMPT TO BALLOON RE-DILATATE THE SAPIEN VALVE. CONVENTIONAL AVR VIA STERNOTOMY WAS THEN PERFORMED. INTRAOPERATIVE FINDINGS SHOWED UNEQUAL DISTRIBUTION OF AORTIC VALVE CALCIFICATION AND INCOMPLETE PROSTHESIS APPOSITION TO THE NATIVE NONCORONARY ANNULUS. THE EDWARDS SAPIEN VALVE WAS EASILY REMOVED AND A 23MM CARPENTER EDWARDS BIOPROSTHETIC VALVE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257768 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention