BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET

    MDR report key: 2902097 · Received January 8, 2013

    Report

    Report Number
    2015691-2013-19036
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VASCULAR COMPLICATIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. THE MANUALS ALSO NOTE THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE IFU ALSO CONTRAINDICATE THE USE OF THE DEVICE IN PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS, SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE THV 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. FURTHERMORE, 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. HOWEVER, DESPITE THE BEST SCREENING TOOLS, A SMALL PERCENTAGE OF PATIENTS WILL HAVE FEMORAL/ILIAC VESSELS THAT ARE NOT AMENABLE TO THE TRANS-FEMORAL APPROACH OR WHERE INCREASED RESISTANCE IS ENCOUNTERED DURING INSERTION OF DEVICES. THE MINIMUM LUMEN DIAMETER FOR THE RF3 (24FR) SHEATH IS 8MM. IN THIS CASE, THE MINIMUM LUMINAL DIAMETER (MM) FOR THE VESSEL WAS 7MM; THERE WAS MILD CALCIFICATION, MILD TORTUOSITY, AND THERE WAS DIFFICULTY WITH THE TRANSITION OF THE DILATORS AND THE SHEATH INTO THE PATIENT'S VASCULATURE. IT IS LIKELY THAT PATIENT VESSEL FACTORS (SMALLER THAN INDICATED SIZE, AND CALCIFICATION OR TORTUOSITY NOT APPRECIABLE ON IMAGING) AND ALONG WITH PROCEDURAL CONSIDERATIONS CONTRIBUTED TO THE REPORTED EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), VASCULAR COMPLICATIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THE EDWARDS THV PATIENT SCREENING AND TRAINING MANUALS INSTRUCTS THE OPERATOR ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL AND ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE THV VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE MINIMUM LUMINAL DIAMETER REQUIRED FOR THE 22FR RF3 SHEATH IS 7MM. IN THIS CASE, PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE EVENT. THE PLANNED ACCESS VESSEL WAS OF ADEQUATE SIZE FOR THE 22FR SHEATH (8.0MM IN DIAMETER), AND THE VESSEL WAS ONLY MILDLY CALCIFIED AND TORTUOUS, HOWEVER, AS REPORTED, THE SHEATH WAS INADVERTENTLY INSERTED IN THE INCORRECT VESSEL. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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 PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS CLINICAL SPECIALIST, DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, ON SHEATH REMOVAL POST SUCCESSFUL VALVE IMPLANTATION, THERE WAS A DISSECTION TO THE RIGHT EXTERNAL ILIAC ARTERY REQUIRING A COVERED STENT AND PERICARDIAL PATCH FOR REPAIR. PER ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SPECIALIST, AFTER THE PROCEDURE THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE CONDITION. PER THE REPORT, THE ILIAC ARTERIES WERE MILDLY TORTUOUS WITH MILD TO MODERATE CALCIFICATION. THE COMMON FEMORAL ARTERIES WHERE NON-CALCIFIED, HOWEVER THEY WERE 7MM IN DIAMETER. THE 25FR AND 28FR DILATORS WERE INSERTED WITH MODERATE DIFFICULTY, AND THE SHEATH WAS INSERTED RELATIVELY EASILY. THE PROCEDURE CONTINUED UNEVENTFULLY UNTIL SHEATH WITHDRAWAL; AT THIS POINT THE DISSECTION WAS NOTED IN THE RIGHT EXTERNAL ILIAC ARTERY. A 7MMX59MM ATRIUM COVERED STENT WAS INSERTED AND DEPLOYED THROUGH FROM THE IPSILATERAL SIDE. THE STENT WAS POST-DILATED USING A 10MM X 40MM FOX PLUS BALLOON. THERE WAS SOME TEARING AT THE SHEATH INSERTION SITE FOR WHICH A PERICARDIAL PATCH WAS USED TO REPAIR. GOOD FLOW WAS NOTED FOLLOWING VASCULAR CLOSURE. THE SHEATH HAD NO APPARENT DEFECT AND THERE WAS NOTHING NOTED TO BE ABNORMAL ABOUT THE SHEATH OR DILATORS DURING PREP.

    Description of Event or Problem · 1

    AS REPORTED BY THE FIELD CLINICAL SPECIALIST, DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THE 22FR RETROFLEX 3 INTRODUCER SHEATH WAS INSERTED INTO THE SUPERFICIAL FEMORAL ARTERY INSTEAD OF THE COMMON FEMORAL RESULTING IN A MAJOR VESSEL TEAR. A BYPASS WAS PERFORMED TO REPAIR THE VESSEL. PER REPORT THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9448 RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26 59210293

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention