BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX3 INTRODUCER SHEATH

    MDR report key: 2951200 · Received February 8, 2013

    Report

    Report Number
    2015691-2013-19242
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 24FR SHEATH IS 8.0MM. IN THIS CASE, THE PATIENT'S MINIMUM LUMINAL DIAMETER (MLD) WAS MEASURED TO BE 8.0MM AND THE ACCESS VESSEL WAS NOTED TO HAVE MODERATE CALCIFICATION AND MILD 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 THE BORDERLINE VESSEL SIZE ALONG WITH CALCIFICATION AND / OR TORTUOSITY 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, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, AFTER SUCCESSFUL VALVE DEPLOYMENT DURING SURGICAL CLOSURE, THE PHYSICIANS NOTICED A PINHOLE RUPTURE THEN LATER AN ILIAC ARTERY DISSECTION. THE PERFORATION WAS REPAIRED WITH A PATCH AND THE ILIAC ARTERY WAS REPAIRED VIA AN ILEO-FEMORAL BYPASS. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE ACCORDING TO THE CASE SUMMARY A SURGICAL CUTDOWN APPROACH WAS USED TO OBTAIN ACCESS TO THE LEFT FEMORAL ARTERY. SERIAL DILATION OF THE EDWARDS DILATORS WAS PREFORMED. THE 25FR DILATOR FAILED TO DELIVER AND AFTER REMOVING THE 25FR DILATOR, THE OPERATORS BELIEVED THE COATING ON THE 25FR DILATOR WAS NOT AS LUBRICIOUS AS THE OTHERS. A SECOND SET OF DILATORS WERE USED AND THERE WAS RESISTANCE IN DELIVERING THE 25FR-28FR DILATORS, BUT ALL THE DILATORS WERE SUCCESSFULLY INSERTED, ALONG WITH THE 24FR SHEATH. THE VALVE WAS SUCCESSFULLY DEPLOYED. DURING THE SURGICAL REPAIR THE OPERATORS NOTICED A PINHOLE RUPTURE THEN LATER AN ILIAC ARTERY DISSECTION. REFER TO 2013-00374-1 FOR THE COMPLAINT ON THE DILATORS. THE OPERATORS BELIEVED IT WAS THE INSERTION OF THE SHEATH OR DILATORS THAT CREATED THIS INJURY. THE PERFORATION WAS REPAIRED WITH A PATCH AND THE ILIAC ARTERY WAS REPAIRED VIA AN ILEO-FEMORAL BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53683 RETROFLEX3 INTRODUCER SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention