BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET

    MDR report key: 3160262 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20304
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 THE TECHNICAL SUMMARY BY EDWARDS, 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 VESSEL LUMEN DIAMETER FOR THE RF3 (22FR) SHEATH IS 7MM. PER REPORT, THIS PATIENT¿S ACCESS VESSEL DIAMETER WAS (6.8-7MM); ACCESS WAS GAINED VIA SURGICAL CUTDOWN; AND THERE WAS NOTED DIFFICULTY DURING SHEATH INSERTION. IT IS POSSIBLE THAT PATIENT FACTORS (CALCIFICATION AND/OR TORTUOSITY NOT APPRECIABLE ON IMAGING, SMALLER THAN INDICATED TO BORDERLINE MINIMUM LUMINAL VESSEL DIAMETER) ALONG WITH PROCEDURAL CONSIDERATIONS CONTRIBUTED TO THE REPORTED 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

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A FEMORAL TAVR PROCEDURE THE PATIENT¿S ILIAC ARTERY WAS INJURED AND FLOW WAS LIMITED. THE PATIENTS ARTERY WAS REPAIRED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) ALONG WITH COVERED STENT PLACEMENT. A PATCH WAS PLACED ON THE VESSEL AT THE SHEATH INSERTION SITE. FINAL ANGIOGRAM REVEALED PATENT FLOW THROUGHOUT THE VESSEL. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND VESSEL REPAIR. THIS PATIENT WILL BE RESCHEDULED FOR A TRANSAPICAL TAVR. PER REPORT, DURING THE CASE CONTRALATERAL ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY AND RIGHT FEMORAL VEIN WITHOUT ISSUE. A SURGICAL CUTDOWN WAS PERFORMED ON THE LEFT GROIN AND ACCESS WAS OBTAINED. DILATORS WERE INSERTED UP TO THE 25 FR SIZE. THE 22FR SHEATH WAS ADVANCED OVER A SUPER STIFF WIRE AND RESISTANCE WAS MET AT THE EXTERNAL ILIAC. THE 22FR SHEATH WAS REMOVED AND THE DILATORS WERE REINSERTED. NEXT, A COOK 22FR SHEATH WAS ALSO ATTEMPTED AND WOULD NOT PASS. IT WAS DETERMINED WITH ANGIOGRAPHY THAT THERE WAS NO PERFORATION OR DISSECTION BUT THE INTIMA OF THE VESSEL HAD BEEN DAMAGED IN A FLOW LIMITING MANNER. AT THIS TIME THE IMPLANT TEAM DECIDED TO ABORT THE PROCEDURE AND REPAIR THE VESSEL. ACCESS IN THE LEFT COMMON ILIAC ARTERY WAS OBTAINED FROM THE CONTRALATERAL APPROACH FOR REPAIR. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NOTHING ABNORMAL NOTICED WHILE INSPECTING THE DEVICES (DILATORS AND SHEATH) PRIOR TO USE. INSERTION OF THE SHEATH WAS A CHALLENGE AND ONLY WENT IN TO THE LEVEL OF THE DISTAL COMMON ILIAC. THE SHEATH WAS REMOVED EASILY, BUT IT WAS NOTED WITH CONTRAST INJECTION THAT WHILE THERE WASN¿T A PERFORATION OR DISSECTION, THE INTIMA OF THE VESSEL WAS DISRUPTED WITH THE EDGE OF THE SHEATH UPON INSERTION AND THE INJURY CONTINUED UP THROUGH THE EXTERNAL ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261350 RETROFLEX 3/ SAPIEN INTRODUCER SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 9120S23 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention