BEUDAMED
    FDA Adverse Event Death Summary report: N

    PREFORM GUIDEWIRE - SAFARI2

    MDR report key: 9949218 · Received April 10, 2020

    Report

    Report Number
    2126666-2020-00028
    Event Type
    Death
    Date Received
    April 10, 2020
    Date of Event
    March 24, 2020
    Report Date
    April 10, 2020
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K151244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE PRODUCT WAS REPORTEDLY DISPOSED. LOT TRACEABILITY WAS NOT PROVIDED. THE LACK OF LOT TRACEABILITY PREVENTS PERFORMING A DEVICE HISTORY RECORDS REVIEW FOR ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE IMPACTED ON THE EVENT AS REPORTED. A REVIEW OF THE MANUFACTURING PROCESSES INDICATES THAT DURING MANUFACTURING AND PACKAGING OF THIS PRODUCT THE OPERATORS ARE INSTRUCTED TO 100% VISUALLY INSPECT FOR ANY OBVIOUS DEFECT PRIOR TO SHIPMENT. AS INDICATED IN THE DEVICE INSTRUCTIONS FOR USE (DFU) WARNINGS SECTION, "WHEN ADVANCING OR REMOVING THE GUIDEWIRE, ALWAYS USE FLUOROSCOPIC GUIDANCE WITH RADIOGRAPHIC EQUIPMENT THAT PROVIDES HIGH-RESOLUTION IMAGES. NEVER POSITION THE GUIDEWIRE BLINDLY, AS THIS MAY RESULT IN MISPLACEMENT, DISSECTION OR PERFORATION." AT THIS TIME, IT IS NOT POSSIBLE TO ASSIGN A DEFINITIVE ROOT CAUSE FOR THE EVENT AS REPORTED. BASED ON THE INFORMATION PROVIDED, IT APPEARS THAT CLINICAL CONDITIONS MAY HAVE IMPACTED ON THE EVENT AS REPORTED. REVIEW OF THE DIRECTIONS FOR USE NOTES THE REPORTED EVENT AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TAVR/TAVI PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: AS A LEARNING POINT, THE ONLY THING I CAN MAKE SENSE OF IS THAT WE WERE PUSHING HARD TO GET THE DEVICE THROUGH THE I-SLEEVE WITH THE SAFARI WIRE IN PLACE, AND PERHAPS THE ELBOW OF THE WIRE DAMAGED THE INTIMA OF THE ARCH OR KNOCKED OFF A PIECE OF PLAQUE THAT WEAKENED THE INTIMA IN THIS LOCATION. IT WAS REPORTED THAT DURING THE INSERTION OF THE VALVE SYSTEM THERE WAS SOME RESISTANCE NOTICED AND DELIVERY STOPPED. UPON REVIEW ON FLUORO IT APPEARED THAT THERE WAS A KINK IN THE DELIVERY SYSTEM, STILL IN THE ISLEEVE IT WAS CAREFULLY REMOVED FOR INSPECTION. THE SYSTEM DEFINITELY HAD A KINK AND SO DECIDED THAT IT WAS NOT GOING TO BE USED. I-SLEEVE WAS REMOVED AND ACCORDION APPEARANCE NOTICED. EDWARDS VALVE AND SYSTEM PREPPED WITH E-SHEATH USED WITH NO ISSUES. PATIENT HAD NO ISSUES AFTER THE CASE AND REMAINED STABLE UNTIL TRANSFER TO RECOVERY AREA. UPDATE TODAY- PATIENT DIED FROM RETROGRADE TYPE A DISSECTION-- CAUSE YET TO BE DETERMINED. THIS PATIENT NEEDED TO GO BACK TO OR FOR A THROMBECTOMY YESTERDAY FOR AN ISCHEMIC LEFT LEG WHERE THERE WAS A CLOT REMOVED IN THE EXTERNAL ILIAC/FEMORAL AREA. IN THE OR, IT WAS NOTED THAT THERE WAS A FEMORAL DISSECTION WHICH WAS REPAIRED AND PATIENT WAS STABLE UNTIL THIS MORNING WHEN HE PASSED AWAY. I WAS TOLD THAT THE INITIAL CAUSE OF DEATH IS THOUGHT TO BE OF AN AORTIC DISSECTION. AT THE TIME OF THE IMPLANT YESTERDAY, I WAS INFORMED THAT THE INSERTION OF THE I-SLEEVE INTO THE LEFT FEMORAL WAS DONE WITHOUT RESISTANCE. THE DIFFICULTY THAT FOLLOWED WITH THE INSERTION OF THE DEVICE WAS FELT IMMEDIATELY AFTER WHICH TIME BOTH THE ISLEEVE AND DEVICE WAS REMOVED. THE DELIVERY SYSTEM ONLY WENT UP TO APPROXIMATELY HALF OF THE ISLEEVE. TO SUMMARIZE, MY UNDERSTANDING IS THAT THE PATIENT WAS STABLE FOLLOWING THE TAVI, AND THEN HAD TO GO BACK TO THE OPERATING ROOM FOR A THROMBECTOMY, WHERE THEY ALSO NOTICED A FEMORAL DISSECTION WHICH WAS REPAIRED. THE PATIENT WAS STABLE FOLLOWING THESE SURGERIES IN THE OPERATION ROOM, AND THEN THE NEXT DAY DIED PRESUMABLY DUE TO AN AORTIC DISSECTION. THE PHYSICIAN HAS PROPOSED THAT THE AORTIC DISSECTION MAY HAVE BEEN DUE TO SAFARI2 WHILE HAVING DIFFICULTIES INSERTING THE ACURATE TF DS INTO THE ISLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414268 PREFORM GUIDEWIRE - SAFARI2 WIRE GUIDE DQX LAKE REGION MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death