BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MYNXGRIP

    MDR report key: 11775423 · Received May 5, 2021

    Report

    Report Number
    3004939290-2021-02138
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    March 1, 2021
    Report Date
    May 5, 2021
    Manufacturer
    CORDIS SANTA CLARA
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: SHAMSELDIN M, BERGERT H, NEUMEISTER A, PULS R. ENDOVASCULAR FOREIGN BODY REMOVAL OF A MYNXGRIP POLYETHYLENE GLYCOL (PEG) SEALANT EMBOLUS USING A CEREBRAL STENT RETRIEVER. CVIR ENDOVASC. 2021 MAR 1;4(1):23. DOI: 10.1186/S42155-020-00197-0. PMID: 33646460; PMCID: PMC7921258 SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. THE PUBLICATION IS ATTACHED. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE BY SHAMSELDIN M, BERGERT H, NEUMEISTER A, PULS R. ENDOVASCULAR FOREIGN BODY REMOVAL OF A MYNXGRIP POLYETHYLENE GLYCOL (PEG) SEALANT EMBOLUS USING A CEREBRAL STENT RETRIEVER. CVIR ENDOVASC. 2021 MAR 1;4(1):23. DOI: 10.1186/S42155-020-00197-0. PMID: 33646460; PMCID: PMC7921258, THE SEALANT OF AN UNKNOWN MYNXGRIP VCD HAD TO BE REMOVED FROM THE ARTERY USING A NON-CORDIS STENT RETRIEVER. THE PATIENT SUFFERED ACUTE LIMB ISCHEMIA IN THE LEFT FOOT WITH DISTAL POPLITEAL EMBOLIZATION WITH INVOLVEMENT OF BELOW THE KNEE TRIFURCATION DUE TO AN INTRA ARTERIAL FOREIGN BODY EMBOLISM OF THE MYNXGRIP SEALANT . THE DEVICE WAS USED FOR VASCULAR CLOSURE AFTER A BALLOON ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS THE LEFT COMMON FEMORAL ARTERY (CFA) USING A RETROGRADE APPROACH. THE SYMPTOMS PRESENTED LATER IN THE DAY. THE PATIENT WAS TAKEN FOR PROCEDURE TO REMOVE THE EMBOLIC SEALANT. RIGHT FEMORAL ACCESS WAS OBTAINED WITH A NON CORDIS SHEATH AND THE SEALANT WAS REMOVED USING A NON CORDIS STENT RETRIEVER AND NON CORDIS ASPIRATION CATHETER. POST PROCEDURAL IMAGING REVEALED COMPLETE REMOVAL OF THE FOREIGN BODY WITH NORMAL BLOOD FLOW RESTORED. 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 MISDEPLOYMENT (INTRAVASCULAR)¿, ¿ACUTE LIMB ISCHEMIA¿, AND ¿EMBOLISM¿ COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. PATIENT AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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, PATIENTS WITH BLEEDING DISORDERS SUCH AS THROMBOCYTOPENIA (PLATELET COUNT <100,000/MM3), HEMOPHILIA, VON WILLEBRAND¿S DISEASE OR ANEMIA (HGB <10 G/ DL, HCT <30%), PATIENTS WITH UNCONTROLLED HYPERTENSION (SYSTOLIC BP >180 MM HG), PATIENTS WITH MORBID OBESITY (BMI >40 KG/M2), PATIENTS WHO ARE PREGNANT OR LACTATING, PATIENTS WITH DOCUMENTED INR >1.5 OR PATIENTS CURRENTLY RECEIVING GLYCOPROTEIN IIB/IIIA PLATELET INHIBITORS. 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 SHAMSELDIN M, BERGERT H, NEUMEISTER A, PULS R. ENDOVASCULAR FOREIGN BODY REMOVAL OF A MYNXGRIP POLYETHYLENE GLYCOL (PEG) SEALANT EMBOLUS USING A CEREBRAL STENT RETRIEVER. CVIR ENDOVASC. 2021 MAR 1;4(1):23. DOI: 10.1186/S42155-020-00197-0. PMID: 33646460; PMCID: PMC7921258, THE SEALANT OF AN UNKNOWN MYNXGRIP VCD HAD TO BE REMOVED FROM THE ARTERY USING A NON-CORDIS STENT RETRIEVER. THE PATIENT SUFFERED ACUTE LIMB ISCHEMIA IN THE LEFT FOOT WITH DISTAL POPLITEAL EMBOLIZATION WITH INVOLVEMENT OF BELOW THE KNEE TRIFURCATION DUE TO AN INTRA ARTERIAL FOREIGN BODY EMBOLISM OF THE MYNXGRIP SEALANT . THE DEVICE WAS USED FOR VASCULAR CLOSURE AFTER A BALLOON ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE ACCESS SITE WAS THE LEFT COMMON FEMORAL ARTERY (CFA) USING A RETROGRADE APPROACH. THE SYMPTOMS PRESENTED LATER IN THE DAY. THE PATIENT WAS TAKEN FOR PROCEDURE TO REMOVE THE EMBOLIC SEALANT. RIGHT FEMORAL ACCESS WAS OBTAINED WITH A NON CORDIS SHEATH AND THE SEALANT WAS REMOVED USING A NON CORDIS STENT RETRIEVER AND NON CORDIS ASPIRATION CATHETER. POST PROCEDURAL IMAGING REVEALED COMPLETE REMOVAL OF THE FOREIGN BODY WITH NORMAL BLOOD FLOW RESTORED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671469 UNKNOWN MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB CORDIS SANTA CLARA UNK-MYNXGRIP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R