BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANTA 18F VASCULAR CLOSURE DEVICE

    MDR report key: 9503948 · Received December 20, 2019

    Report

    Report Number
    3010252479-2019-00118
    Event Type
    Injury
    Date Received
    December 20, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ESSENTIAL MEDICAL, INC.
    Product Code
    MGB
    UDI-DI
    00856279007062
    PMA / PMN Number
    P180025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT FOLLOWING DEPLOYMENT BLEEDING OCCURRED WHICH REQUIRED A TRANSFUSION OF 5 UNITS AND A COVERED STENT PLACED AT THE ACCESS SITE TO ACHIEVE HEMOSTASIS. THE ROOT CAUSE OF THE LIFE-THREATENING BLEED REQUIRING 5 UNITS OF BLOOD IS A TRACT DEPLOYMENT. THE IFU WARNS "DO NOT USE IF THE PATIENT HAS MARKED OBESITY OR CACHEXIA (BMI >40 KG/M2 OR <20 KG/M2)." THE IFU LISTS "IN THE EVENT THAT BLEEDING FROM THE FEMORAL ACCESS SITE PERSISTS AFTER THE USE OF THE MANTA DEVICE, THE PHYSICIAN SHOULD ASSESS THE SITUATION. BASED ON THE PHYSICIAN ASSESSMENT OF THE AMOUNT OF BLEEDING, USE MANUAL OR MECHANICAL COMPRESSION, APPLICATION OF BALLOON PRESSURE FROM A SECONDARY ACCESS SITE, PLACEMENT OF A COVERED STENT, AND/OR SURGICAL REPAIR TO OBTAIN HEMOSTASIS" AS A PRECAUTION. THE FOLLOWING ADVERSE EVENTS RELATED TO THE DEPLOYMENT OF VASCULAR CLOSURE DEVICES HAS BEEN IDENTIFIED IN THE IFU: "OTHER ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, OR ARTERIO-VENOUS FISTULA, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION." RISK DOCUMENTATION WAS REVIEWED, AND TRACT DEPLOYMENT IS A KNOWN RISK. THE OCCURRENCE RATE OF THIS TYPE OF INCIDENT REMAINS BELOW RISK DOCUMENTATION ACCEPTABLE OCCURRENCE LIMITS. THE DOCUMENT HISTORY WAS REVIEWED AND SHOWED NO NON-CONFORMITIES RELATED TO THIS EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN OPENED TO REVIEW DEVICE HISTORY RECORD, RISK DOCUMENTATION, AND CASE IMAGING. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUSPECTED CAUSE OF THIS COMPLICATION WAS A TRACT DEPLOYMENT. DUE TO THE HIGH BMI OF THE PATIENT, THE MANTA SHEATH/INTRODUCER MAY NOT HAVE ENTERED THE VESSEL AT ALL (AS EVIDENCED BY THE BUNCHED-UP GUIDEWIRE REFERENCED ABOVE). THE ANCHOR WAS LIKELY DEPLOYED IN THE TRACT, RESULTING IN UNINHIBITED ARTERIOTOMY BLEEDING. HOWEVER, AN INVESTIGATION TO MAKE FINAL CONCLUSIONS HAD BEEN OPENED. MANTA'S INSTRUCTIONS FOR USE WARNS THE USER NOT TO USE MANTA IF THE PATIENT HAS MARKED OBESITY OR CACHEXIA (BMI>40 KG/M2 OR <20 KG/M2.) THE INSTRUCTIONS FOR USE ALSO IDENTIFY POTENTIAL ADVERSE EVENTS RELATED TO DEPLOYMENT OF VASCULAR CLOSURE DEVICES INCLUDING ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, OR ARTERIO-VENOUS FISTULA, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION.

    Description of Event or Problem · 1

    NATURE & DETAILS OF COMPLAINT: SUMMARY OF EVENT: (INCLUDE USER, PROCEDURE TYPE, INDEX DEVICE/SHEATH, CLOSURE ACT, EVENT DETAILS, SUSPECTED CAUSE, TREATMENT PERFORMED, PATIENT OUTCOME, IF KNOWN) THE REPORTER CONTACTED ESSENTIAL MEDICAL, INC. ON 03-DEC-2019 TO REPORT AN EVENT THAT OCCURRED DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE THAT SAME DAY. THE REPORTER STATED THIS WAS A TAVR CASE UTILIZING AN ACCURATE NEO-MEDIUM VALVE AS PART OF A TRIAL (THE VALVE IS NOT COMMERCIALLY APPROVED). THE VALVE WAS DELIVERED THROUGH A 14F ISLEEVE SHEATH (THE SHEATH IS EXPANDABLE, BUT THE EXACT OD OF THE SHEATH WAS UNKNOWN TO THE REPORTER AS OF THE WRITING OF THIS COMPLAINT SUBMISSION). THE OPERATOR WAS DR. PANAICH, HIS FIRST CASE IN TRAINING WITH MANTA. PRIOR TO THE CASE, DR. PANAICH WAS INFORMED BY THE SALES REPRESENTATIVE, DR. J. REBELSKY, THAT PATIENTS WITH A BMI >40, WHILE NOT AN EXPLICIT CONTRAINDICATION, WERE NOT INCLUDED IN THE IDE TRIAL AND MAY NOT BE THE IDEAL CASE FOR HIS INITIAL MANTA USE. THE REPORTER ENTERED THE CASE JUST PRIOR TO VALVE DEPLOYMENT. PUNCTURE LOCATION DEPTH WAS MEASURED AS 8.0 CM + 1.0 CM. THE VALVE WAS DEPLOYED WITHOUT ISSUE, AND ISLEEVE SHEATH WAS EXCHANGED FOR THE 18F MANTA SHEATH OVER A SOFT J-WIRE. DURING INSERTION OF THE MANTA SHEATH, THE PATIENT VOICED HAVING SOME DISCOMFORT. THE MANTA DEVICE WAS DEPLOYED, RESULTING IN MODERATE BLEEDING. A POST-CLOSURE ANGIOGRAPHY SHOWED SUBSTANTIAL BLEEDING FROM THE ACCESS SITE. THE OPERATING TEAM QUICKLY HELD FIRM MANUAL PRESSURE AND MADE ARRANGEMENTS TO INFLATE A BALLOON ACROSS THE ACCESS SITE. MEANWHILE, THE ANESTHESIA TEAM TRANSFUSED THE PATIENT MULTIPLE TIMES AND WORKED TO STABILIZE THE PATIENT'S BLOOD PRESSURE. DURING SUBSEQUENT ANGIOGRAPHY WITH THE BALLOON INFLATED, IT WAS NOTED THAT THE MANTA LOCK APPEARED FARTHER AWAY FROM THE ACCESS SITE THAN NORMAL. A SECOND LOCK ADVANCEMENT WAS EXECUTED WITH NO CHANGE AS A RESULT. IT WAS DETERMINED THAT THE LOCK HAD BEEN ADVANCED AS MUCH AS POSSIBLE. DURING THE SUBSEQUENT POST-CLOSURE ANGIOGRAPHY, IT WAS NOTICED THAT THE GUIDEWIRE WAS BUNCHED UP AROUND THE ACCESS SITE. ULTIMATELY, A COVERED STENT WAS PLACED ACROSS THE ACCESS SITE, AND HEMOSTASIS WAS OBTAINED. FINAL ANGIOGRAPHY SHOWED NO ACCESS SITE BLEEDING AND POSITIVE BLOOD FLOW TO DISTAL VESSELS. THE PATIENT WAS OBSERVED TO HAVE A LARGE HEMATOMA IN THEIR ABDOMINAL AREA. APPROXIMATELY 5 UNITS OF BLOOD WERE GIVEN. CASE OCCURRED IN THE MORNING, AS OF 5:25 PM ON (B)(6) 2019, THE PATIENT WAS REPORTED TO BE STABLE AND TALKED WITH CAREGIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294938 MANTA 18F VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC. 2115 MN1901224 00856279007062

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention