BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSCATHETER SAPIEN HEART VALVE

    MDR report key: 8162177 · Received December 13, 2018

    Report

    Report Number
    2015691-2018-05263
    Event Type
    Injury
    Date Received
    December 13, 2018
    Report Date
    November 14, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM TO. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-OCT-2013) WAS USED AS THE OCCURRENCE DATE. THE TYPE OF THV VALVE IS UNKNOWN; HOWEVER, THESE ARE THE POSSIBLE 510K NUMBER FOR SAPIEN, SAPIEN XT AND SAPIEN 3: P100041, P130009, AND P140031. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY, INCLUDING PERFORATION OR DISSECTION OF VALVULAR STRUCTURES [E.G. INJURY TO THE MITRAL VALVE/ APPARATUS] IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE TAVR PROCEDURE. CHORDAE TENDINAE RUPTURE IN TAVR CAN OCCUR DURING ADVANCEMENT OF THE GUIDEWIRE, BAV CATHETER, OR DELIVERY SYSTEM AND IS MOST LIKELY TO OCCUR WITH ANTEGRADE APPROACHES, HOWEVER, CAN OCCUR WITH A RETROGRADE APPROACH. IN SOME CASES INTERVENTION MAY NOT BE REQUIRED; HOWEVER, IF THE RUPTURE IS SIGNIFICANT IT TYPICALLY RESULTS IN PROFOUND MITRAL REGURGITATION AND WILL REQUIRE INTERVENTION TO PREVENT PERMANENT INJURY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, AND CAREFUL MANIPULATION OF DEVICES. PER THE THV TA TRAINING MANUALS, AFTER GAINING LV ACCESS WITH THE 0.035¿ SOFT GUIDEWIRE, THE WIRE SHOULD BE JIGGLED UNDER TEE IMAGING OF THE MITRAL VALVE. AN INCREASE IN MR SUGGESTS WIRE ENTANGLEMENT IN THE MITRAL SUB-VALVULAR APPARATUS. IF ENTANGLEMENT IS SUSPECTED, THE GUIDEWIRE SHOULD BE COMPLETELY REMOVED FROM THE VENTRICLE; THE OPERATOR SHOULD CHANGE DIRECTION OF THE NEEDLE AND REINSERT THE GUIDEWIRE INTO THE VENTRICLE, CHECKING AGAIN FOR WIRE ENTANGLEMENT. THE TF TRAINING MANUAL ALSO PROVIDES GUIDANCE FOR VALVE CROSSING AND WIRE EXCHANGE: EXCHANGE 0.035¿ AMPLATZ EXTRA-STIFF WIRE WITH PRE-SHAPED DISTAL END IN LEFT VENTRICLE. ENSURE GUIDING CATHETER IS ADVANCED UPON WIRE EXCHANGE TO ENSURE EXCHANGE WIRE DOES NOT GET CAUGHT IN THE MITRAL CHORDAE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH THE EXACT CAUSE REPORTED MITRAL REGURGITATION CANNOT BE CONFIRMED BASED ON THE LIMITED INFORMATION, IN ADDITION TO THE PROCEDURE ITSELF, PATIENT FACTORS AND CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE REPORTED 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. THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2018-05060, 2015691-2018-05061, 2015691-2018- 05262. REFERENCE FOR ARTICLE: MIURA, M., SHIRAI, S., UEMURA, Y., HAYASHI, M., TAKIGUCHI, H., ITO, S., YANO, M., KAWAGUCHI, T., MORINAGA, T., ISOTANI, A., KAKUMOTO, S., SEO, K., ARAI, Y., SAKAGUCHI, G., ANDO, K. (2018). CLINICAL IMPACT OF INTRAVENTRICULAR CONDUCTION ABNORMALITIES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH BALLOON-EXPANDABLE VALVES. THE AMERICAN JOURNAL OF CARDIOLOGY. RETRIEVED FROM: HTTPS://DOI.ORG/10.1016/J.AMJCARD.2018.10.005.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH A LITERATURE ARTICLE, ¿CLINICAL IMPACT OF INTRAVENTRICULAR CONDUCTION ABNORMALITIES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH BALLOON-EXPANDABLE VALVES¿, DURING THE STUDY PERIOD OF OCTOBER 2013 THROUGH SEPTEMBER 2016, MODERATE-SEVERE MITRAL REGURGITATION (MR) WAS OBSERVED IN 6 PATIENTS. THE STUDY INCLUDED SAPIEN XT AND SAPIEN 3 VALVES VIA THE TA AND TF APPROACHES. INFORMATION REGARDING THE EXACT TIMING AND POTENTIAL CAUSES OF THE EVENTS WAS NOT PROVIDED BY THE ARTICLE¿S AUTHORS. INFORMATION REGARDING POSSIBLE TREATMENT WAS ALSO NOT PROVIDED. INFORMATION REGARDING THE NATIVE ANNULAR DIAMETER AND DEGREE OF VALVULAR CALCIFICATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998551 EDWARDS TRANSCATHETER SAPIEN HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention