BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    MDR report key: 9484314 · Received December 17, 2019

    Report

    Report Number
    2015691-2019-04716
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    November 1, 2009
    Report Date
    November 29, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO:2015691-2019-04715.

    Additional Manufacturer Narrative · 0

    E1.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM NOVEMBER 2009 TO OCTOBER 2017. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD ((B)(6) 2009) 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. REFERENCE ARTICLE: LAREYRE, FABIEN, ET AL. "DIABETES MELLITUS IS NOT ASSOCIATED WITH WORSE VASCULAR OUTCOME FOLLOWING PERCUTANEOUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION." ACTA CARDIOLOGICA (2018): 1-7. RETROPERITONEAL BLEED IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL RISK ASSOCIATED WITH THE TAVR PROCEDURE. A POST PROCEDURAL BLEED/ HEMORRHAGE WITHOUT AN OBVIOUS SOURCE OF BLEEDING IS A RARE BUT POTENTIALLY LIFE THREATENING COMPLICATION OF CORONARY/CARDIAC INTERVENTIONAL PROCEDURES, AND TENDS TO OCCUR MORE FREQUENTLY IN THE PRESENCE OF MORE AGGRESSIVE ANTICOAGULATION REGIMENS. POSSIBLE CAUSES INCLUDE, PUNCTURE OF THE FEMORAL ARTERY ABOVE THE INGUINAL LIGAMENT AND ABOVE THE INFERIOR EPIGASTRIC ARTERY, ALLOWING THE RESULTANT BLEEDING TO EXTEND INTO THE RETROPERITONEAL SPACE. THIS TYPE OF BLEEDING MAY NOT BE OBVIOUS OR RECOGNIZED UNTIL THE POST PROCEDURAL PERIOD. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OR POSSIBLE CONTRIBUTING FACTORS FOR THE RETROPERITONEAL BLEEDING COULD NOT BE CONFIRMED, HOWEVER THIS TYPE OF COMPLICATION IS TYPICALLY RELATED TO PUNCTURE TECHNIQUE FOR INITIAL ARTERIAL ACCESS. 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, ¿DIABETES MELLITUS IS NOT ASSOCIATED WITH WORSE VASCULAR OUTCOME FOLLOWING PERCUTANEOUS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION¿, REGARDING A GROUP OF PATIENTS WHO UNDERWENT TAVI WITH AN EDWARDS SAPIEN, SAPIEN XT OR SAPIEN 3 VALVE BY TRANSFEMORAL APPROACH BETWEEN NOVEMBER 2009 AND OCTOBER 2017, THE FOLLOWING 30-DAY POST-OPERATIVE OUTCOMES WERE OBSERVED: 1 PATIENT HAD A RETROPERITONEAL HEMATOMA LEADING TO MAJOR BLEEDING WHICH REQUIRED TRANSFUSION ASSOCIATED WITH A SURGICAL RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272233 UNKNOWN EDWARDS TRANSFEMORAL SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS TRANSFEMORAL SHEATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention