BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX3 INTRODUCER SHEATH

    MDR report key: 3052871 · Received April 11, 2013

    Report

    Report Number
    2015691-2013-19790
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VASCULAR COMPLICATIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TAVR PROCEDURE. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS AND DILATORS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PER THE EDWARDS TRAINING MANUALS, PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 22FR SHEATH IS 7.0MM. THIS PATIENT¿S MINIMUM LUMINAL DIAMETER (MLD) MEASURED 7.1MM AND THE ACCESS VESSEL WAS NOTED TO HAVE MILD CALCIFICATION AND MODERATE TORTUOSITY. THE TRANSFEMORAL TAVR PROCEDURE REQUIRES THE INSERTION OF LARGE BORE DEVICES, AND THERE IS A RISK THAT PLACEMENT OF THE SHEATH AND/OR DILATORS MAY RESULT IN OR CONTRIBUTE TO VESSEL DAMAGE. IN THIS CASE, THE EXACT CAUSE FOR THE REPORTED VASCULAR EVENT CANNOT BE CONFIRMED; HOWEVER, IT IS LIKELY THAT BORDERLINE VESSEL SIZE AND MODERATE TORTUOSITY ALONG WITH CALCIFICATION NOT APPRECIABLE ON IMAGING MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFUS 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED VIA THE EDWARDS CLINICAL SPECIALIST, POST SUCCESSFUL DEPLOYMENT OF THE EDWARDS SAPIEN VALVE, DURING ACCESS SITE CLOSURE, A DISSECTION FROM THE EXTERNAL ILIAC TO THE COMMON FEMORAL ARTERY WAS NOTED. A GRAFT WAS SEWN IN TO REPAIR THE DISSECTION. THE REPAIR WAS SUCCESSFUL AND, AT LAST REPORT, THE PATIENT WAS IN A STABLE CONDITION. ACCORDING TO THE CASE SUMMARY, PERCUTANEOUS ACCESS WAS OBTAINED ON THE LEFT SIDE FOR THE PIGTAIL CATHETER AND THE TEMPORARY PACEMAKER. A SURGICAL CUT DOWN WAS PERFORMED ON THE RIGHT SIDE FOR DEVICE ACCESS. THE EDWARDS DILATORS WERE USED UP TO 25FR WITHOUT AN ISSUE. BAV AND VALVE DEPLOYMENT WERE PERFORMED WITHOUT INCIDENT. POST DEPLOYMENT ECHO ASSESSMENT REVEALED ZERO PVL OR CAI. AN AORTIC ROOT ANGIOGRAM DEMONSTRATED PATENCY OF THE CORONARY ARTERIES. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. WHILE PHYSICIANS WERE WORKING TO CLOSE THE SURGICAL CUTDOWN, A PERIPHERAL ANGIOGRAM WAS TAKEN. A DISSECTION FROM THE EXTERNAL ILIAC TO THE COMMON FEMORAL WAS NOTED. A GRAFT WAS SEWN IN TO REPAIR THE DISSECTION. THE REPAIR WAS SUCCESSFUL AND THE PATIENT WAS REMOVED FROM THE TABLE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156870 RETROFLEX3 INTRODUCER SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59285086

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention