BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    MDR report key: 10881288 · Received November 21, 2020

    Report

    Report Number
    2015691-2020-14588
    Event Type
    Injury
    Date Received
    November 21, 2020
    Date of Event
    September 1, 2015
    Report Date
    November 4, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2020-14584; 2015691-2020-14585; 2015691-2020-14586; 2015691-2020-14587; 2015691-2020-14588; 2015691-2020-14589; 2015691-2020-14590; 2015691-2020-14591; 2015691-2020-14592; 2015691-2020-14593; 2015691-2020-14594; 2015691-2020-14595; 2015691-2020-14596; 2015691-2020-14597; 2015691-2020-14598; 2015691-2020-14599; 2015691-2020-14600.

    Additional Manufacturer Narrative · 1

    THIS IS FIVE OF SEVENTEEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE ARTICLE: TIWANA, JASLEEN, ET AL. "CONTEMPORARY TRANSCATHETER MITRAL VALVE REPLACEMENT FOR MITRAL ANNULAR CALCIFICATION OR RING." CARDIOVASCULAR INTERVENTIONS 13.20 (2020): 2388-2398. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM SEPTEMBER 2015 TO APRIL 2020. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-SEPTEMBER 2015) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT  SHEATH MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS TRANSFEMORAL SHEATH. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS TRANSFEMORAL SHEATH:  K093877- RETROFLEX 3TM INTRODUCER SHEATH SET; P130009 - EDWARDS EXPANDABLE INTRODUCER SHEATH SET; P140031- EDWARDS ESHEATH INTRODUCER SET.   THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, MODEL 9600TFX, AND ACCESSORIES ARE INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT LOW RISK FOR OPEN SURGICAL THERAPY (I.E., PREDICTED RISK OF SURGICAL MORTALITY >=1% AT 30 DAYS, BASED ON THE SOCIETY OF THORACIC SURGEONS (STS) RISK SCORE AND OTHER CLINICAL CO-MORBIDITIES UNMEASURED BY THE STS RISK CALCULATOR).   THE EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE, MODEL 9750TFX, AND ACCESSORIES ARE INDICATED FOR PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC OR MITRAL VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT LOW RISK FOR OPEN SURGICAL THERAPY (I.E., PREDICTED RISK OF SURGICAL MORTALITY = 8% AT 30 DAYS, BASED ON THE STS RISK SCORE AND OTHER CLINICAL CO-MORBIDITIES UNMEASURED BY THE STS RISK CALCULATOR).   PER REPORT, THE DEVICE WAS USED IN AN OFF-LABEL IMPLANTATION IN THE MITRAL POSITION.  AS THERE ARE NO SPECIFIC IFU OR TRAINING MATERIALS RELATED TO MITRAL PROCEDURES, THE AVAILABLE TRAINING MATERIALS WERE REVIEWED ONLY FOR INFORMATION POTENTIALLY RELEVANT TO THE DEVICE USE.   CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER VALVE REPLACEMENT PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT DEFICIENCY MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. BASED ON THE LIMITED INFORMATION PROVIDED IN THE ARTICLE, THE CAUSE OF THE VASCULAR ACCESS COMPLICATIONS IS UNKNOWN. 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 ARTICLE ¿CONTEMPORARY TRANSCATHETER MITRAL VALVE REPLACEMENT FOR MITRAL ANNULAR CALCIFICATION OR RING¿ REGARDING A  SINGLE-CENTER STUDY WAS CONDUCTED OF VALVE¿IN¿MITRAL ANNULAR CALCIFICATION (VIMAC) AND VALVE-IN-RING (VIRING) TMVR FROM SEPTEMBER 2015 TO APRIL 2020. IN-HOSPITAL AND 30-DAY OUTCOMES WERE ASSESSED. THE FOLLOWING OBSERVATIONS WERE MADE:   DURING THE 30 DAY HOSPITALIZATION, THERE WERE 2 PATIENTS WITH VASCULAR ACCESS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346387 UNKNOWN EDWARDS TRANSFEMORAL SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other