BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 DILATOR KIT

    MDR report key: 3130685 · Received May 24, 2013

    Report

    Report Number
    2015691-2013-20169
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRE
    PMA / PMN Number
    K093554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 AN EDWARDS LIFESCIENCES TECHNICAL SUMMARY, 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 A 22 FR SHEATH IS 7.0 MM. IN THIS CASE, THE ACCESS VESSEL¿S MINIMUM LUMINAL DIAMETER WAS SMALLER THAN THE MINIMUM INDICATED SIZE, AT 6.0 MM. THE CAUSE FOR THE REPORTED VESSEL TEAR CANNOT BE CONFIRMED. HOWEVER, THE SMALL AND LESS THAN INDICATED VESSEL DIAMETER ALONG WITH MODERATE VESSEL CALCIFICATION AND SEVERE TORTUOUSITY LIKELY CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST THAT DURING A TRANSFEMORAL TAVR PROCEDURE, AFTER SERIAL DILATION USING THE 18 AND 22F DILATORS, THE 22F RF3 SHEATH WOULD NOT PASS THE EXTERNAL ILIAC. THE SHEATH WAS REMOVED AND A 25F DILATOR WAS ADVANCED; HOWEVER IT ALSO WOULD NOT PASS THE SAME EXTERNAL ILIAC LOCATION. THE PHYSICIAN THEN TRIED TO ADVANCE A 22F COOK SHEATH WITH NO SUCCESS. AT THIS TIME IT WAS DECIDED TO ABORT THE PROCEDURE, REMOVE THE SHEATH, AND CLOSE WITH PROSTAR CLOSURE DEVICES. CLOSURE WAS NOT SUCCESSFUL AND A RIGHT FEMORAL ANGIO SHOWED A TEAR AT THE BIFURCATION OF SUPERFICIAL FEMORAL ARTERY AND PROFUNDA FEMORIS ARTERY. A PTA BALLOON WAS INSERTED AND INFLATED VIA THE CONTRALATERAL SIDE TO CONTROL THE BLEEDING AND A SURGICAL REPAIR OF THE TEAR WAS PERFORMED. IT WAS REPORTED THE PATIENT REMAINED STABLE. ADDITIONAL INFORMATION INDICATES THE MINIMUM LUMINAL DIAMETER OF THE VESSEL AT THE ACCESS SITE WAS 6.0 MM. THE VESSELS WERE ALSO REPORTED TO BE MODERATELY CALCIFIED WITH SEVERE TORTUOSITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231373 RETROFLEX 3 DILATOR KIT DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE EDWARDS LIFESCIENCES 9100DKS7 59429815

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention