BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTA 18F

    MDR report key: 12514019 · Received September 22, 2021

    Report

    Report Number
    3010252479-2021-00109
    Event Type
    Injury
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    August 26, 2021
    Manufacturer
    ESSENTIAL MEDICAL, INC
    Product Code
    MGB
    UDI-DI
    00856279007062
    PMA / PMN Number
    P180025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO RETURN PRODUCT EVALUATION COULD BE COMPLETED. THE DEVICE LOT HISTORY RECORD REVIEW INDICATED NO NON-CONFORMITIES RELATED TO THIS LOT, THEREFORE, SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. AS REPORTED, FOLLOWING A TAVR, A 18F MANTA WAS DEPLOYED FOR CLOSURE IN THE RIGHT COMMON FEMORAL ARTERY. THE ARTERIOTOMY WAS APPROXIMATELY 6.4MM, NO TORTUOSITY, MILD CALCIFICATION IN THE ILIACS AND AORTA, WITH A DEPLOYMENT DEPTH MEASUREMENT OF 6 + 1. ACCESS WAS GAINED UTILIZING MICROPUNCTURE AND ULTRASOUND; POSITIONING WAS A HIGH STICK AND HIGH BIFURCATION. THE IFU WARNS DO NOT USE MANTA IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITED INTO THE VESSEL. THE PATIENT WAS NOTED AS HAVING A LOW PLATELET COUNT AND A HIGH AORTIC INSUFFICIENCY (AI) PRESSURE. THE SAFETY AND EFFECTIVENESS OF THE MANTA DEVICE HAS NOT BEEN ESTABLISHED IN PATIENT POPULATIONS WITH A BLEEDING DISORDER, INCLUDING THROMBOCYTOPENIA (<100,000 CELLS/UL PLATELET COUNT). FOLLOWING DEPLOYMENT, BRISK OOZING WAS PRESENT, THE LOCK ADVANCEMENT TUBE WAS READVANCED, PRESSURES APPLIED TO CONTROL THE BLEED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY. WHILE IN RECOVERY, THE PATIENT COMPLAINED OF BACK PAIN. A CT PERFORMED REVEALED A RETROPERITONEAL BLEED POCKET. AN UNDISCLOSED AMOUNT OF BLOOD UNITS WAS TRANSFUSED, AND THE PATIENT REMAINED STABLE WHILE THE VASCULAR SURGEON WAS CALLED IN. DURING THE SURGICAL INTERVENTION, A PSEUDO-ANEURYSM WAS REVEALED, THE SURGEON REMOVED THE PSEUDOANEURYSM AND PLACED A COVERED STENT EVEN THOUGH THE ARTERY WAS ALREADY TAMPONADED. ACCORDING TO INFORMATION SUBMITTED FOR THIS INVESTIGATION, THE PROCEDURE OUTCOME STATES COMPLETED WITH THIS DEVICE. THEREFORE, THE MANTA WAS NOT EXPLANTED AND REMAINED IN THE PATIENT. DUE TO INSUFFICIENT INFORMATION REGARDING THE INITIAL AND DEPLOYMENT PROCEDURES, AND NO POST PROCEDURE IMAGING SUBMITTED FOR INVESTIGATIVE PURPOSES, A DETERMINATION FOR THE ROOT CAUSE OF THE PSEUDO-ANEURYSM REQUIRING TREATMENT IS INCONCLUSIVE. A PSEUDO-ANEURYSM CAN GO UNDETECTED AND NOT CAUSE ANY COMPLICATION AND CAN OCCUR BECAUSE OF SURGERY OR TRAUMA. IF HEMOSTASIS IS NOT ACHIEVED FOLLOWING THE USE OF MANTA, ASSESS THE SITUATION AND BASED ON THE ASSESSMENT OF THE AMOUNT OF BLEEDING, USE COMPRESSION, BALLOON PRESSURE, OR PLACEMENT OF A COVERED STENT, AND/OR SURGICAL REPAIR TO OBTAIN HEMOSTASIS. POTENTIAL ADVERSE EVENTS RELATED TO THE DEPLOYMENT OF VASCULAR CLOSURE DEVICES INCLUDE RETROPERITONEAL BLEEDING BECAUSE OF ACCESS ABOVE THE INGUINAL LIGAMENT OR THE MOST INFERIOR BORDER OF THE EPIGASTRIC ARTERY (IEA); AND OTHER ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ANY LARGE BORE INTERVENTION, INCLUDING THE USE OF THE MANTA, INCLUDE OOZING FROM THE PUNCTURE SITE.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN OPENED TO REVIEW DEVICE HISTORY RECORD AND RISK DOCUMENTATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS REPORTED: (B)(6) MALE UNDERWENT A HEART VALVE REPLACEMENT. PHYSICIAN MEASURED DEPTH TWICE AT 6 CM WITH PROPER PROCEDURE. IT WAS WRITTEN THAT THE DEPTH WAS 6 CM +1 CM DOWN. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. UPON MANTA DEPLOYMENT THERE WAS BRISK OOZING, SO THE PHYSICIAN REDEPLOYED THE MANTA. AT THIS TIME THERE WAS STILL OOZING. THE PHYSICIAN APPLIED OCCLUSIVE PRESSURE, THEN TRANSITIONING TO NON-OCCLUSIVE. AFTER 14 MINS OF MANUAL PRESSURE, THE GROIN WAS UNDER CONTROL. THE PATIENT WENT TO THE HOLDING ROOM AREA PRIOR TO GOING BACK TO HIS ROOM. AFTER COMPLAINING OF BACK PAIN, CT WAS PERFORMED, AND A RETROPERITONEAL BLEED (RP) POCKET WAS DISCOVERED, AND VASCULAR SURGERY WAS CONSULTED. THE PATIENT WAS STABLE AT THIS TIME, SO PHYSICIAN WAS NOT CONCERNED WITH ACTIVE BLEEDING. ADDITIONAL INFORMATION RECEIVED ON 27 AUG 2021: DURING A TAVR PROCEDURE, ULTRASOUND AND MICRO PUNCTURE SINGLE ACCESS WERE OBTAINED IN THE RIGHT CFA. THE ACCESS STICK WAS DESCRIBED AS A "HIGH" STICK IN THE BIFURCATION. RIGHT CFA VESSEL SIZE MEASURED AT 6.4 MM. THERE WAS MILD CALCIFICATION IN THE ILIAC VESSELS AND AORTA. NO TORTUOSITY WAS NOTED. PRIOR MANTA DEPLOYMENT, SBP WAS LESS THAN 116 MMHG, ACT WAS 150, A TOTAL OF 12000 UNITS OF HEPARIN WAS INTRAVENOUSLY GIVEN, AND A TOTAL OF 80 MG OF PROTAMINE WAS INTRAVENOUSLY GIVEN. AN UNKNOWN AMOUNT OF BLOOD TRANSFUSIONS WAS ADMINISTERED. PATIENT WAS STABLE FOR 45 MINUTES AFTER DISCOVERY OF RP BLEED, AND BEFORE VASCULAR BROUGHT TO SURGERY TO EVACUATE LARGE HEMATOMA. PATIENT IS CURRENTLY IN CRITICAL CARE. THE PATIENT HAD LOW PLATELET COUNT AND HIGH AI PRESSURE. PHYSICIAN THINKS THAT MAY HAVE BEEN A CONTRIBUTING FACTOR. ADDITIONAL INFORMATION RECEIVED ON 17 SEPT 2021: IN SURGERY, IT WAS DISCOVERED TO BE A PSEUDOANEURYSM THAT THE VASCULAR SURGEON EVACUATED AND THEN USED A COVERED STENT. CURRENT PATIENT CONDITION IS REPORTED AS FINE AND OUT OF CRITICAL CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408969 MANTA 18F VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC 2115 MN2101375 00856279007062

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention