BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MYNXGRIP

    MDR report key: 12393989 · Received August 31, 2021

    Report

    Report Number
    3004939290-2021-02311
    Event Type
    Injury
    Date Received
    August 31, 2021
    Report Date
    August 31, 2021
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE IS UNKNOWN AS THIS IS A LITERATURE COMPLAINT. AS REPORTED IN THE LITERATURE ARTICLE BY MIRANDA MD, J.A., PALLISTER MD, Z., HANSRAJ MD, N., AND MONTERO-BAKER MD, M. (2021), DUPLEX-ULTRASOUND ASSISTED MYNX CLOSURE OF SUPERFICIAL FEMORAL ARTERY ANTEGRADE ACCESS FOLLOWING LOWER-EXTREMITY ENDOVASCULAR INTERVENTION, JOURNAL OF CRITICAL LIMB ISCHEMIA, VOLUME 1, PG 1-6, HTTPS://WWW.HMPGLOBALLEARNINGNETWORK.COM/SITE/CLIJOURNAL/ORIGINAL-CONTRIBUTION/DUPLEX-ULTRASOUND-ASSISTED-MYNX-CLOSURE-SUPERFICIAL-FEMORAL, AN UNKNOWN MYNXGRIP FAILED TO ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS SUCCESSFULLY APPLIED FOR MORE THAN 30 MINUTES. HOWEVER, THE PATIENT DEVELOPED ACUTE LIMB ISCHEMIA FROM THE MANUAL COMPRESSION AND REQUIRED IMMEDIATE REINTERVENTION. THE ACCESS SITE AND SUPERFICIAL FEMORAL ARTERY (SFA) WERE FOUND TO BE OCCLUDED. THE SITE WAS REVASCULARIZED USING THROMBOLYTIC INFUSION AND SUCTION THROMBECTOMY FROM A CONTRALATERAL APPROACH. THE PROCEDURE USED AN IPSILATERAL, ANTEGRADE APPROACH OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE MYNX BALLOON WAS PREPPED WITH A 50:50 CONTRAST:SALINE RATIO. THE MYNX DEVICE WAS INTRODUCED, AND THE BALLOON WAS INFLATED UNDER ULTRASOUND GUIDANCE. ACT WAS MAINTAINED AT <180 SECONDS AND SYSTOLIC BLOOD PRESSURE WAS <180MMHG. THE DEVICE AND THE SHEATH WERE SLOWLY RETRACTED TO THE ARTERIOTOMY SITE UNDER CONSTANT ULTRASOUND VISUALIZATION. WHEN INTRALUMINAL ANTERIOR WALL APPOSITION OF THE BALLOON WAS SEEN ON ULTRASOUND, THE POLYETHYLENE GLYCOL PLUG WAS DEPLOYED. TENSION WAS HELD AND THEN THE PLUG WAS RELEASED PER THE DEVICE INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿SEALANT -FAILURE TO ACHIEVE HEMOSTASIS¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. LIMB ISCHEMIA WAS REPORTED WHILE MANUAL COMPRESSION WAS BEING PERFORMED TO ACHIEVE HEMOSTASIS. LIMB ISCHEMIA IS DEFINED AS A QUICKLY DEVELOPING OR SUDDEN DECREASE IN LIMB PERFUSION, USUALLY PRODUCING NEW OR WORSENING SYMPTOMS OR SIGNS, AND OFTEN THREATENING LIMB VIABILITY. ACUTE LOWER EXTREMITY ISCHEMIA IS OVERWHELMINGLY RELATED TO ARTERIAL OCCLUSION. THE RISK FACTORS FOR LOWER EXTREMITY ISCHEMIA INCLUDE THE USE OF LARGER CATHETERS OR SHEATHS IN RELATIVELY SMALLER ARTERIES, PERIPHERAL VASCULAR DISEASE, OLDER AGE, CARDIOMYOPATHY, HYPERCOAGULABLE STATES AND VESSEL DISSECTION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WHICH IS NOT INTENDED AS A MITIGATION OF RISK, HE SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS: PEDIATRIC PATIENTS OR OTHERS WITH SMALL COMMON FEMORAL ARTERIES OR VEINS (<5 MM IN DIAMETER), PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE IN THE VICINITY OF THE PUNCTURE, PATIENTS WITH PRIOR SURGICAL PROCEDURE, PTA, STENT PLACEMENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY OR VEIN. REVIEW OF THE LIMITED INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS AND/OR PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY MIRANDA MD, J.A., PALLISTER MD, Z., HANSRAJ MD, N., AND MONTERO-BAKER MD, M. (2021), DUPLEX-ULTRASOUND ASSISTED MYNX CLOSURE OF SUPERFICIAL FEMORAL ARTERY ANTEGRADE ACCESS FOLLOWING LOWER-EXTREMITY ENDOVASCULAR INTERVENTION, JOURNAL OF CRITICAL LIMB ISCHEMIA, VOLUME 1, PG 1-6, HTTPS://WWW.HMPGLOBALLEARNINGNETWORK.COM/SITE/CLIJOURNAL/ORIGINAL-CONTRIBUTION/DUPLEX-ULTRASOUND-ASSISTED-MYNX-CLOSURE-SUPERFICIAL-FEMORAL, AN UNKNOWN MYNXGRIP FAILED TO ACHIEVE HEMOSTASIS. MANUAL COMPRESSION WAS SUCCESSFULLY APPLIED FOR MORE THAN 30 MINUTES. HOWEVER, THE PATIENT DEVELOPED ACUTE LIMB ISCHEMIA FROM THE MANUAL COMPRESSION AND REQUIRED IMMEDIATE REINTERVENTION. THE ACCESS SITE AND SUPERFICIAL FEMORAL ARTERY (SFA) WERE FOUND TO BE OCCLUDED. THE SITE WAS REVASCULARIZED USING THROMBOLYTIC INFUSION AND SUCTION THROMBECTOMY FROM A CONTRALATERAL APPROACH. THE PROCEDURE USED AN IPSILATERAL, ANTEGRADE APPROACH OF THE SUPERFICIAL FEMORAL ARTERY (SFA). THE MYNX BALLOON WAS PREPPED WITH A 50:50 CONTRAST:SALINE RATIO. THE MYNX DEVICE WAS INTRODUCED AND THE BALLOON WAS INFLATED UNDER ULTRASOUND GUIDANCE. ACT WAS MAINTAINED AT <180 SECONDS AND SYSTOLIC BLOOD PRESSURE WAS <180MMHG. THE DEVICE AND THE SHEATH WERE SLOWLY RETRACTED TO THE ARTERIOTOMY SITE UNDER CONSTANT ULTRASOUND VISUALIZATION. WHEN INTRALUMINAL ANTERIOR WALL APPOSITION OF THE BALLOON WAS SEEN ON ULTRASOUND, THE POLYETHYLENE GLYCOL PLUG WAS DEPLOYED. TENSION WAS HELD AND THEN THE PLUG WAS RELEASED PER THE DEVICE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293344 UNKNOWN MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention