BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER AMULET

    MDR report key: 20301013 · Received September 25, 2024

    Report

    Report Number
    2135147-2024-04719
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NGV
    UDI-DI
    00811806013497
    PMA / PMN Number
    P200049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT POST AMULET DEVICE PROCEDURE BEFORE DISCHARGE THE PATIENT DEVELOPED FEVER. THE PATIENT WAS NOTED TO HAVE SHORTNESS OF BREATH AND CHEST X-RAY (CRX) NOTED MILD CONGESTION, AND A V-SCAN SHOWED TRACE PERICARDIAL EFFUSION. THE PATIENT HAD A FEVER AGAIN DESPITE REDUCED LEFT ANKLE SWELLING. THE PATIENT ALSO EXPERIENCED ANOTHER EPISODE OF HYPOTENSION WITH INCREASE IN DROWSINESS AND DIZZINESS. THE PATIENT DEVELOPED DIARRHEA ON COLCHICINE AND SUBSEQUENTLY COLCHICINE WAS WITHHELD. INFORMATION FROM FIELD INDICATED THAT THE PATIENT'S ACTIVATED CLOTTING TIME LEVELS WERE 170-344 S DURING PROCEDURE AND HEPARIN WAS ADMINISTERED. THERE WAS ONE PARTIAL RECAPTURE BEFORE SUCCESSFUL IMPLANT DURING PROCEDURE AND NO RESIDUAL SHUNT WAS REPORTED AFTER IMPLANT. IT WAS ALSO NOTED THE PATIENT'S SEPTIC WORKUP WAS NEGATIVE, HYPOTENSION NOTED, BLOOD RESULTS WERE NORMAL, AND THE PATIENT IMPROVED AFTER WITHHOLDING ANTIHYPERTENSIVES AND ADMINISTERING FLUIDS. THE DEVICE REMAINS IMPLANTED AND WILL NOT RETURN TO ABBOTT FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, AND THE PRODUCT MET ALL SPECIFICATIONS. THE CAUSE OF REPORTED PATIENT EFFECTS COULD NOT BE CONCLUSIVELY DETERMINED. INFORMATION FROM FIELD INDICATED THAT THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE FEVER TO BE DUE TO A GOUT ATTACK AS IT WAS ASSOCIATED WITH PAIN AND SWELLING OF THE LEFT ANKLE. THE REPORTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS A MEDICATION WAS ADMINISTERED. THE PATIENT VITALS IMPROVED AFTER ADJUSTMENT OF MEDICATION REGIMEN AND AFTER FLUID RESTRICTIONS AND DIURETICS. IT WAS NOTED THE LATEST V-SCAN SHOWED NO EFFUSION AND CXR DID NOT CONFIRM ANY CONGESTION. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    CLINICAL INFORMATION: (B)(6) - CATALYST IDE, PATIENT SITE ID: (B)(6) IT WAS REPORTED THAT ON (B)(6) 2024, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER WAS IMPLANTED. THE PATIENT'S LEFT ATRIAL APPENDAGE (LAA) DIMENSIONS WERE AS FOLLOWS: ORIFICE - 24MM; DEPTH - 17MM; LANDING ZONE - 21-22MM; AND LEFT ATRIAL PRESSURE - 11MMHG. DURING PROCEDURE, THE PATIENT WAS GIVEN 200ML OF FLUIDS AND HEPARIN WAS ADMINISTERED. THE PATIENT'S ACTIVATED CLOTTING TIME (ACT) LEVELS WERE 170-344S. DURING PROCEDURE, THERE WAS ONE PARTIAL RECAPTURE BEFORE SUCCESSFUL IMPLANT OF THE 25MM AMPLATZER AMULET. AFTER IMPLANT, NO RESIDUAL SHUNT WAS REPORTED. POST-PROCEDURE BUT PRIOR TO DISCHARGE, IT WAS REPORTED THAT ON (B)(6) 2024 THAT THE PATIENT DEVELOPED A FEVER. IT WAS REPORTED ON (B)(6) 2024, PATIENT WAS NOTED TO HAVE SHORTNESS OF BREATH AND CHEST X-RAY (CXR) NOTED MILD CONGESTION. A V-SCAN SHOWED TRACE PERICARDIAL EFFUSION. N-TERMINAL PRO-B-TYPE NATRIURETIC PEPTIDE (NT-PROBNP) LEVELS WERE HIGH AND PATIENT WAS PLACED ON FLUID RESTRICTION AND GIVEN LASIX. IT WAS ALSO NOTED THE PATIENT'S SEPTIC WORKUP WAS NEGATIVE, HYPOTENSION NOTED, BLOOD RESULTS WERE NORMAL, AND THE PATIENT IMPROVED AFTER WITHHOLDING ANTIHYPERTENSIVES AND ADMINISTERING FLUIDS. THE PATIENT HAD A FEVER AGAIN ON (B)(6) 2024 DESPITE REDUCED LEFT ANKLE SWELLING. THE PATIENT WAS KEPT ON INTRAVENOUS LEVOFLOXACIN AND GIVEN PANADOL. THE PATIENT DEVELOPED DIARRHEA ON COLCHICINE AND SUBSEQUENTLY COLCHICINE WAS WITHHELD. THE PATIENT ALSO EXPERIENCED ANOTHER EPISODE OF HYPOTENSION WITH INCREASE IN DROWSINESS AND DIZZINESS. V-SCAN DID NOT CONFIRM ANY PERICARDIAL EFFUSION, CXR STILL NOTED MILD CHEST CONGESTION. BLOOD PRESSURE MEDICATION AND METFORMIN WAS WITHHELD AND PATIENT WAS GIVEN GELOFUSINE. THE PATIENT BECAME HYPOGLYCEMIC ON (B)(6) 2024 AND WAS GIVEN D50 AND IMPROVED. PATIENT VITALS IMPROVED AFTER ADJUSTMENT OF MEDICATION REGIMEN AND AFTER FLUID RESTRICTIONS AND DIURETICS. IT WAS NOTED THE LATEST V-SCAN ON (B)(6) 2024 SHOWED NO EFFUSION AND CXR DID NOT CONFIRM ANY CONGESTION. THE PHYSICIAN ATTRIBUTED THE CAUSE OF THE FEVER TO BE DUE TO A GOUT ATTACK AS IT WAS ASSOCIATED WITH PAIN AND SWELLING OF THE LEFT ANKLE. THE PATIENT WAS REPORTED DISCHARGED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097795 AMPLATZER AMULET CARDIAC PLUG NGV ABBOTT MEDICAL 8962497 00811806013497

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| H