BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETROFLEX 3 INTRODUCER SHEATH SET

    MDR report key: 2268377 · Received September 28, 2011

    Report

    Report Number
    2015691-2011-16230
    Event Type
    Injury
    Date Received
    September 28, 2011
    Date of Event
    September 8, 2011
    Report Date
    September 8, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K093877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRODUCER CATHETER WAS NOT IMPLANTED IN THE PATIENT, THE IMPLANT DATE PREVIOUSLY PROVIDED IS NOT APPLICABLE TO THIS DEVICE. ADDITIONAL FIELDS WERE SELECTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AT THE SITE. THIS (B)(6) FEMALE PATIENT WAS RANDOMIZED TO THE (B)(4) CLINICAL TRIAL ON (B)(6) 2011. THE INDICATION FOR THE INDEX PROCEDURE WAS AORTIC STENOSIS (NYHA CLASS III). ACCESS VESSEL DIAMETER WAS 8.4MM. LEFT FEMORAL ACCESS WAS OBTAINED VIA A SURGICAL CUT DOWN OF LEFT FEMORAL ARTERY. THE PHYSICIAN NOTICED RESISTANCE WHILE ADVANCING THE DELIVERY SYSTEM THROUGH THE INTRODUCER SHEATH. THUS EXCESSIVE FORCE/RETRACTION WAS REQUIRED TO ADVANCE THE DELIVERY SYSTEM THROUGH THE SHEATH. IT WAS LATER DISCOVERED THAT A KINK IN THE SHEATH CAUSED THE RESISTANCE. AFTER CAREFUL MANEUVERING, THE VALVE AND THE DELIVERY SYSTEM WERE SUCCESSFULLY ADVANCED THROUGH THE SHEATH. A 23MM EDWARDS SAPIEN TRANSCATHETER HEART VALVE WAS SUCCESSFULLY DEPLOYED AT THE NATIVE ANNULUS DURING RAPID PACING. PRIOR TO SURGICAL CLOSURE OF THE VESSEL A PERIPHERAL ANGIOGRAM WAS PERFORMED WHERE A SMALL DISSECTION OF THE LEFT COMMON ILIAC (LCI) WAS NOTICED AND SUCCESSFULLY TREATED. ADDITIONAL INFORMATION RECEIVED FROM THE CLINICAL SPECIALIST INDICATES THE LCI DIAMETER AT DISSECTION SITE WAS 9+MM. THE VESSEL CALCIFICATION WAS DESCRIBED AS MILD. THE SHEATH WAS INSPECTED PRIOR TO USE WITH NO VISIBLE DEFECTS OBSERVED. THE SHEATH WAS PREPPED ACCORDING TO THE IFU AND DEEMED SUITABLE FOR THE PROCEDURE BY THE IMPLANTING PHYSICIAN. THE REPORTED KINK WAS NOT DETECTED UNTIL INSERTION OF THE VALVE AND DELIVERY SYSTEM, AND THE KINK WAS LATER CONFIRMED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW FOR THE SHEATH SET WAS PERFORMED AND ALL MANUFACTURER'S SPECIFICATIONS WERE MET PRIOR TO RELEASE FOR DISTRIBUTION. PER THE DEVICE'S INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON AORTIC VALVULOPLASTY (BAV) AND THE USE OF ANESTHESIA INCLUDE BUT ARE NOT LIMITED TO CARDIOVASCULAR INJURY INCLUDING PERFORATION OR DISSECTION OF VESSELS, WHICH MAY REQUIRE INTERVENTION. IN THIS CASE, THE EXACT CAUSE FOR THE REPORTED VASCULAR COMPLICATION COULD NOT BE CONFIRMED, AND THERE IS NO EVIDENCE OF A MANUFACTURING NON-CONFORMANCE PER THE DEVICE HISTORY RECORD REVIEW. HOWEVER, THERE ARE PROCEDURAL FACTORS THAT COULD HAVE POSSIBLY CONTRIBUTED THIS EVENT. ALTHOUGH THE VESSEL APPEARS TO HAVE BEEN APPROPRIATE IN SIZE WITH MILD CALCIFICATION, THE EXCESSIVE FORCE, RETRACTION, AND MANEUVERING DURING THE USE OF THE DEVICE COULD HAVE POSSIBLY CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE (B)(4) STUDY INDICATING THAT FOLLOWING SUCCESSFUL DEPLOYMENT OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND PRIOR TO SURGICAL CLOSURE OF THE VESSEL, A PERIPHERAL ANGIOGRAM WAS PERFORMED WHERE A SMALL DISSECTION OF THE LEFT COMMON ILIAC (LCI) WAS NOTICED. THE DISSECTION WAS TREATED USING 10X60MMX135CM COVERED STENT FOLLOWED BY POST DILATION USING AN 8.0 X 40MM BALLOON AND SURGICAL CLOSURE OF THE VESSEL. NO FURTHER COMPLICATIONS WERE NOTED DURING THE PROCEDURE, THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROFLEX 3 INTRODUCER SHEATH SET INTRODUCER CATHETER DYB EDWARDS LIFESCIENCES 9120S23 59060815

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention ATRION QL2330 SYRINGE (B)(4)| SAPIEN HEART VALVE (B)(4)| RETROFLEX DELIVERY SYSTEM (B)(4)| RETROFLEX DILATOR KIT (B)(4)| CRIMPER (SAPIEN) (B)(4)