BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 3932888 · Received July 14, 2014

    Report

    Report Number
    2015691-2014-01584
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TAVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. THE THV PHYSICIAN TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT TRANSFEMORAL PASSAGE OF THE DEVICES. THE IFU CONTRAINDICATES 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/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 PHYSICIAN TRAINING MANUAL ALSO LISTS THE MINIMUM RECOMMENDED VESSEL SIZE FOR EACH SIZE DEVICE. 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. IN MANY CASES, THE VESSEL MINIMUM LUMINAL DIAMETER (MLD) MAY BE BORDERLINE OR BELOW THE INDICATED SIZE. IN ADDITION, SIGNIFICANT CALCIFICATION AND/OR TORTUOSITY, NOT ALWAYS APPRECIABLE ON IMAGING, COULD BE CONTRIBUTING FACTORS TO THE EVENT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR THE 24 FR RF3 SHEATH IS 8MM. IN THIS CASE, THE MINIMUM LUMINAL DIAMETER OF THE ACCESS VESSEL WAS 8.3MM AND THE VESSELS WERE NOTED TO BE MILDLY CALCIFIED AND MILDLY TORTUOUS. THE CAUSE FOR THE VESSEL PERFORATION CANNOT BE CONFIRMED; HOWEVER, IT IS POSSIBLE THAT CALCIFICATION AND/OR TORTUOSITY NOT APPRECIABLE ON IMAGING CONTRIBUTED TO THE EVENT. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE TRANSFEMORAL TAVR PROCEDURE, UPON REMOVAL OF THE SHEATH, ANGIOGRAM REVEALED A PERFORATION OF THE FEMORAL ARTERY. THE RFA WAS ACCESSED AND DILATORS ADVANCED. THE 24FR SHEATH WAS INSERTED WITHOUT DIFFICULTY WITH THE USUAL AMOUNT OF RESISTANCE ACCORDING TO THE IC. THE CASE PROCEEDED NORMALLY. BAV PERFORMED, VALVE DEPLOYED WITH THE EXPECTED RESULT. AFTER THE DELIVERY SYSTEM WAS REMOVED, THE 24FR SHEATH WAS PULLED BACK INTO THE CFA AND AN ANGIOGRAM WAS PERFORMED. THERE DID NOT APPEAR TO BE ANY EXTRAVASATION AND THE PATIENT¿S BP WAS UNCHANGED. THE SHEATH WAS THEN REMOVED COMPLETELY AND THE PERCLOSE SUTURES WERE CLOSED AND ANOTHER ANGIOGRAM WAS PERFORMED. THIS ANGIOGRAM REVEALED SOME EXTRAVASATION FROM THE REIA AND THE PATIENT BECAME HYPOTENSIVE. THE LOWER EXTREMITY ANGIOGRAPHY WAS RE-REVIEWED, AND IT WAS EVIDENT THAT THERE WAS A PERFORATION. A WIRE WAS ADVANCED FROM THE CONTRALATERAL SIDE INTO THE SFA. A LARGE SHEATH WAS THEN ADVANCED INTO THE RCIA FROM THE LEFT SIDE. ONE 8MM ATRIUM ICAST COVERED STENT WAS IMPLANTED. THE STENT WAS POST-DILATED WITH A PERIPHERAL BALLOON. BLOOD PRODUCTS WERE ADMINISTERED TO THE PATIENT TO PREVENT HYPOVOLEMIA. POST STENT ANGIOGRAM REVEALED HEMOSTASIS AND THE PATIENT WAS NORMOTENSIVE. THE PATIENT WAS TRANSFERRED TO THE CCU FOR FURTHER CARE AND MONITORING. THE MINIMUM LUMINAL DIAMETER (MLD) OF THE ACCESS VESSEL WAS 8.3MM AND THE VESSELS WERE NOTED TO BE MILDLY CALCIFIED AND MILDLY TORTUOUS. THE PATIENT RECEIVED BLOOD TRANSFUSIONS OVER NIGHT FOR DROPPING HCT ON SERIAL LABS. SHE WENT INTO CARDIOGENIC SHOCK REQUIRING HIGH PRESSOR REQUIREMENTS AND WAS STARTED ON CRRT. THE FAMILY WAS CONSULTED AND THEY DECIDED TO WITHDRAW CARE. THE PATIENT EXPIRED ONE DAY POST TAVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410616 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S26

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention