BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS INTRODUCER SHEATH

    MDR report key: 9483084 · Received December 17, 2019

    Report

    Report Number
    2015691-2019-04703
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    October 1, 2012
    Report Date
    November 26, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL TO REPORT RELATED MDR NUMBERS AND REFERENCE ARTICLE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: AND 2015691-2019-04704 AND 2015691-2019-04706. HULMAN M, BENA M, ARTEMIOU P, GASPAROVIC I, HUDEC V, HASAKOVA J. TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE BALLOON EXPANDABLE AORTIC BIOPROSTHETIC VALVE IN HIGH RISK PATIENTS WITH SEVERE AORTIC STENOSIS: INTERMEDIATE-TERM RESULTS FROM THE REGISTER OF THE CLINIC OF CARDIAC SURGERY. BRATISL LEK LISTY. 2019;120(6):462-467. DOI: 10.4149/BLL_2019_074. PUBMED PMID: 31223028.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE, FOR THE 1 PATIENT HAD A BLEEDING NEEDING RE-EXPLORATION. THE DATE OF THE EVENT(S) IS UNKNOWN. ACCORDING TO THE ARTICLE THE DATE RANGE FOR THIS EVENT(S) IS FROM OCTOBER 2012 TO DECEMBER 2016. FOR THIS REASON, THE FIRST DAY OF THE RANGE WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT DEVICE MODEL NUMBER IS NOT AVAILABLE. THEREFORE, THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS INTRODUCER SHEATH. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS INTRODUCER SHEATH ARE LISTED BELOW; THIS REPORT WILL REMAIN BLANK P130009 - EDWARDS EXPANDABLE INTRODUCER SHEATH SET (ASSOCIATED WITH SAPIEN XT); P140031- EDWARDS EXPANDABLE INTRODUCER SHEATH SET (ASSOCIATED WITH SAPIEN 3) PER THE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS/CARDIOVASCULAR INJURY, INCLUDING PERFORATION OF THE VENTRICLE OR MYOCARDIUM, BLEEDING, AND INJURY AT THE SITE OF VENTRICULAR ACCESS THAT MAY REQUIRE REPAIR ARE POTENTIAL COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TAVR PROCEDURE. PER LITERATURE REVIEW, RISK FACTORS FOR APICAL LACERATION AND BLEEDING INCLUDE FRIABLE TISSUE, FATTY APEX, CHRONIC STEROID USE, DILATED LV WITH THINNED WALLS, AND HYPERTENSION DURING REMOVAL OF THE SHEATH. WHILE PATIENT CHARACTERISTICS ARE IMPORTANT, ACHIEVING GOOD HEMOSTATIC CONTROL OF THE LV APEX IS ONE OF THE MOST CRITICAL STEPS IN ENSURING THE SUCCESS OF THE TRANSAPICAL PROCEDURE, PARTICULARLY IN THE ELDERLY WITH FRIABLE TISSUE. ADDITIONAL LITERATURE REVIEW CONFIRMS THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. THIS INFORMATION CORRELATES WITH REVIEW OF COMPLAINT HISTORY, REVEALING THAT THE MAJORITY OF APICAL BLEEDING COMPLICATIONS APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. THE THV TRAINING MANUALS NOTE THAT REMOVAL OF THE SHEATH AND ATTEMPTED CLOSURE OF THE APICAL INCISION MAY BE ASSOCIATED WITH BLOOD LOSS. RAPID BURST PACING CAN BE USED TO LOWER THE SYSTEMIC BLOOD PRESSURE DURING SHEATH REMOVAL AND APICAL CLOSURE. THE THV TRAINING MANUALS ALSO RECOMMEND THE PHYSICIAN CONSIDER PERFORMING THE PROCEDURE UNDER FULL CPB SUPPORT FOR CERTAIN PATIENTS, INCLUDING THOSE WITH CARDIOGENIC SHOCK (CARDIAC INDEX < 2 L/MIN PER SQUARE METER) DESPITE VOLUME CHALLENGE AND INOTROPIC SUPPORT, PROFOUND LV, RV, OR BIVENTRICULAR DYSFUNCTION, AND NOTABLY FRIABLE APEX. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS ARE INCONCLUSIVE AS NO ADDITIONAL PATIENT OR PROCEDURAL FACTORS WERE PROVIDED THAT COULD HELP DETERMINE A ROOT CAUSE. 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

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE BY OUR AFFILIATES IN (B)(6): "TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE BALLOON EXPANDABLE AORTIC BIOPROSTHETIC VALVE IN HIGH RISK PATIENTS WITH SEVERE AORTIC STENOSIS: INTERMEDIATE-TERM RESULTS FROM THE REGISTER OF THE CLINIC OF CARDIAC SURGERY", BY AUTHOR HULMAN M, MULTIPLE EVENTS WERE IDENTIFIED. THE PURPOSE OF THIS STUDY IS TO REPORT THE EXPERIENCE IN PERFORMING TRANSAPICAL (TA) TAVR WITH A BALLOON-EXPANDABLE VALVE ONLY BY CARDIAC SURGEONS, WITH ON SITE INTERVENTIONAL CARDIOLOGY SUPPORT. IN THE PERIOD FROM OCTOBER 2012 TO DECEMBER 2016 A TOTAL OF 97 PATIENTS WITH SEVERE AORTIC STENOSIS WERE TREATED WITH THE TRANSAPICAL TAVR PROCEDURE WITH THE EDWARDS SAPIEN XT VALVE IN 31 (32 %) PATIENTS AND THE EDWARDS SAPIEN S3 IN 66 (68 %) PATIENTS. THE FOLLOWING EVENTS WERE IDENTIFIED: 1 PATIENT HAD A BLEEDING NEEDING RE-EXPLORATION 4 PATIENTS HAD A STROKE OR TIA 5 PATIENTS NEEDED A PACEMAKER IMPLANTATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272503 UNKNOWN EDWARDS INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TA SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention