BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MYNX

    MDR report key: 6974472 · Received October 24, 2017

    Report

    Report Number
    3004939290-2017-00398
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    September 25, 2017
    Report Date
    December 4, 2017
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY GUPTA ET AL DISTAL EMBOLIZATION FROM MYNX DEVICE, CONNECTICUT MEDICINE ((B)(6) 2012) 76(9), 545-548; A POSSIBLE INTRAVASCULAR DISTAL EMBOLIZATION FROM THE MYNX VASCULAR CLOSURE DEVICE PLUG POLYMER. HEMOSTASIS WAS ACHIEVED AT THE LEFT CFA (COMMON FEMORAL ARTERY) SITE WITH THE MYNX DEVICE. POST PROCEDURE, IN RECOVERY, THE PATIENT¿S LEFT LEG WAS NOTED TO BE COLD WITH DECREASED DISTAL PULSES AND LOWER LIMB SEGMENTAL PRESSURE MEASUREMENTS REVEALED CRITICAL ISCHEMIA OF THE LEFT LOWER EXTREMITY. A DECISION WAS MADE TO BRING THE PATIENT BACK TO THE CARDIAC CATHETERIZATION LAB AND ARTERIAL ACCESS WAS OBTAINED FROM THE RIGHT CFA. AN ANGIOGRAM CONFIRMED 100% OCCLUSION OF THE DISTAL POPLITEAL ARTERY AT THE LEVEL OF TRIFURCATION LIKELY DUE TO THE EMBOLIZATION FROM THE MYNX PLUG POLYMER. "VERY" FAINT DISTAL FLOW WAS NOTED IN THE POSTERIOR TIBIAL (PT), PERONEAL ARTERY AND ANTERIOR TIBIAL (AT). INTERVENTION WAS DONE WITH ASPIRATION OF A PARTIAL CLOT. RESIDUAL OCCLUSION IN THE DISTAL POPLITEAL ARTERY INVOLVING THE ORIGIN OF THE AT AND TP TRUNK WAS TREATED UNSUCCESSFULLY WITH 3 MG OF INTRA-ARTERIAL TPA ADMINISTERED DIRECTLY AT THE LEVEL OF THE POPLITEAL ARTERY. AN ANGIOGRAPHY A FEW MINUTES LATER SHOWED PERSISTENT OCCLUSION WHICH DID NOT DIMINISH IN SIZE. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH A 3.0 MM X 23 MM STENT WHICH WAS THEN DIRECTED BELOW THE KNEE TO THE LEFT POPLITEAL ARTERY. THIS WAS OVERLAPPED DISTALLY INTO THE TIBIOPERONEAL (TP) TRUNK WITH A 3.0 MM X 18 MM STENT. ANOTHER STENT WAS IMPLANTED INTO THE PT ARTERY. FINAL ANGIOGRAPHY REVEALED A WIDELY PATENT LEFT POPLITEAL ARTERY WITH TWO-VESSEL RUN-OFFS BEING OCCLUDED MOST LIKELY CHRONICALLY AND PATENT TP TRUNK, PT AND PERONEAL ARTERIES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A LOT HISTORY REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT CARDINAL HEALTH IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE (IFU), USERS ARE CAUTIONED THAT SERIOUS ADVERSE EVENTS MIGHT RESULT WITH THE USE OF THE MYNXGRIP VCD IN VESSELS NOT SUITABLE FOR THE USE OF THE DEVICE. DO NOT USE THE MYNXGRIP VCD TO CLOSE ARTERIOTOMIES CREATED IN AREAS OF CALCIFIED PLAQUE OR STENTED SEGMENTS. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #: UNKNOWN AS THE PRODUCT NUMBER AND LOT NUMBER WERE NOT PROVIDED A LOT HISTORY REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, PRODUCT RELEASE AT CARDINAL HEALTH IS CONTINGENT UPON THE SUCCESSFUL COMPLETION OF LOT RELEASE TESTING AND A DOCUMENTATION REVIEW BY THE QUALITY DEPARTMENT. THE COMPLAINT EVALUATION IS CURRENTLY IN PROGRESS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF THE COMPLAINT EVALUATION.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY GUPTA ET AL DISTAL EMBOLIZATION FROM MYNX DEVICE, CONNECTICUT MEDICINE (OCT 2012) 76(9), 545-548; A POSSIBLE INTRAVASCULAR DISTAL EMBOLIZATION FROM THE MYNX VASCULAR CLOSURE DEVICE PEG POLYMER. HEMOSTASIS WAS ACHIEVED AT THE LEFT CFA (COMMON FEMORAL ARTERY) SITE WITH THE MYNX DEVICE. POST PROCEDURE, IN RECOVERY, THE PATIENT¿S LEFT LEG WAS NOTED TO BE COLD WITH DECREASED DISTAL PULSES, AND LOWER LIMB SEGMENTAL PRESSURE MEASUREMENTS REVEALED CRITICAL ISCHEMIA OF THE LEFT LOWER EXTREMITY. A DECISION WAS MADE TO BRING THE PATIENT BACK TO THE CARDIAC CATHETERIZATION LAB AND ARTERIAL ACCESS WAS OBTAINED FROM THE RIGHT CFA. AN ANGIOGRAM CONFIRMED 100% OCCLUSION OF THE DISTAL POPLITEAL ARTERY AT THE LEVEL OF TRIFURCATION, LIKELY DUE TO THE EMBOLIZATION FROM THE MYNX PEG POLYMER. "VERY" FAINT DISTAL FLOW WAS NOTED IN THE POSTERIOR TIBIAL (PT), PERONEAL ARTERY AND ANTERIOR TIBIAL (AT). INTERVENTION WAS DONE WITH ASPIRATION OF A PARTIAL CLOT. RESIDUAL OCCLUSION IN THE DISTAL POPLITEAL ARTERY INVOLVING THE ORIGIN OF THE AT AND TP TRUNK WAS TREATED UNSUCCESSFULLY WITH 3 MG INTRA-ARTERIAL TPA ADMINISTERED DIRECTLY AT THE LEVEL OF THE POPLITEAL ARTERY, AN ANGIOGRAPHY A FEW MINUTES LATER SHOWED PERSISTENT OCCLUSION WHICH DID NOT DIMINISH IN SIZE. A PCI WAS PERFORMED (PERCUTANEOUS CORONARY INTERVENTION) WITH A 3.0 MM X 23 MM STENT WHICH WAS THEN DIRECTED BELOW THE KNEE, TO THE LEFT POPLITEAL ARTERY. THIS WAS OVERLAPPED DISTALLY INTO THE TIBIOPERONEAL (TP) TRUNK, WITH A 3.0 MM X 18 MM STENT. ANOTHER STENT WAS IMPLANTED INTO THE PT ARTERY. FINAL ANGIOGRAPHY REVEALED A WIDELY PATENT LEFT POPLITEAL ARTERY WITH TWO-VESSEL RUN-OFFS, BEING OCCLUDED MOST LIKELY CHRONICALLY AND PATENT TP TRUNK, PT AND PERONEAL ARTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753232 UNKNOWN MYNX DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNK-MYNX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R THE 3 MG THROMBOLYTIC THERAPY| THE 3.0 MM X 18 MM CYPHER¿ STENT| THE 3.0 MM X 23 MM CYPHER¿ STENT