BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 20427597 · Received October 11, 2024

    Report

    Report Number
    2135147-2024-05008
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLED "RESOLUTION OF SEVERE ULCERATIVE COLITIS SECONDARY TO NICKEL ALLERGY FOLLOWING EXPLANTATION OF AMPLATZER SEPTAL OCCLUDER DEVICE: A DELAYED PRESENTATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF ALLERGIC REACTION, ULCERATIVE COLITIS, MIGRAINES, HIVES, AND FLARE-UPS WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED AND MEDICAL REVIEW, THE CAUSE OF THE REPORTED HYPERSENSITIVITY/ALLERGIC REACTION APPEARS TO BE RELATED TO PATIENT CONDITION (ALLERGIC TO NICKEL, PALLADIUM, COBALT, AND VANADIUM). THE REPORTED PATIENT EFFECT OF HYPERSENSITIVITY/ALLERGIC REACTION, AS LISTED IN THE AMPLATZER ASD OCCLUDER SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH AMPLATZER ASD OCCLUDER PROCEDURES. THE CAUSE OF THE REPORTED ULCERATIVE COLITIS, RASH, MIGRAINE, FATIGUE, PAIN, INFLAMMATION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED HOSPITALIZATION AND SURGICAL INTERVENTION WERE RESULT OF CASE-SPECIFIC CIRCUMSTANCES AS THE PATIENT WAS ADMITTED AND THE ASD OCCLUDER WAS EXPLANTED VIA STERNOTOMY. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE ATTACHMENT: ARTICLE TITLE: RESOLUTION OF SEVERE ULCERATIVE COLITIS SECONDARY TO NICKEL ALLERGY FOLLOWING EXPLANTATION OF AMPLATZER SEPTAL OCCLUDER DEVICE: A DELAYED PRESENTATION.

    Description of Event or Problem · 0

    THE ARTICLE, "RESOLUTION OF SEVERE ULCERATIVE COLITIS SECONDARY TO NICKEL ALLERGY FOLLOWING EXPLANTATION OF AMPLATZER SEPTAL OCCLUDER DEVICE: A DELAYED PRESENTATION", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A NOW 27-YEAR-OLD FEMALE PATIENT WITH AN ATRIAL SEPTAL DEFECT (ASD). IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN THE PATIENT WAS 12-YEAR-OLD, AN UNKNOWN AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED FOR ATRIAL SEPTAL DEFECT CLOSURE. IT WAS THEN REPORTED 4-6 MONTHS POST-PROCEDURE, THE PATIENT EXPERIENCED HIVES AND MIGRAINES, FLARING EPISODICALLY OVER THE COURSE OF 9 YEARS. ON AN UNKNOWN DATE WHEN THE PATIENT WAS 22-YEARS-OLD, THE PATIENT DEVELOPED SYMPTOMS OF CHRONIC ABDOMINAL PAIN AND FATIGUE AND WAS DIAGNOSED WITH IRRITABLE BOWEL SYNDROME (IBS). THE PATIENT'S SYMPTOMS DETERIORATED SIGNIFICANTLY TWO YEARS LATER. A DECISION WAS MADE TO PERFORM A COLONOSCOPY AND THE PATIENT WAS DIAGNOSED WITH BIOPSY-PROVEN ULCERATIVE COLITIS (UC). OVER THE NEXT SEVERAL YEARS, THE PATIENT UNDERWENT MULTIPLE SUCCESSIVE MEDICAL MANAGEMENT REGIMENS AND THE UC PROVED REFRACTORY. THE PATIENT ALSO DEVELOPED SIGNIFICANT WEIGHT AND ENERGY LOSS. SURGICAL EVALUATION FOR A TOTAL COLECTOMY AND END-ILEOSTOMY WAS INITIATED, AND SUBSEQUENTLY A SKIN PATCH ALLERGY TEST NOTED STRONG ALLERGIC REACTIONS TO NICKEL, PALLADIUM, COBALT, AND VANADIUM. A DECISION WAS MADE TO EXPLANT THE ASO VIA STERNOTOMY AND CARDIOPULMONARY BYPASS. THE ASD WAS THEN CLOSED WITH AUTOLOGOUS PERICARDIAL PATCH AND STERNAL CLOSURE WAS PERFORMED WITH NONABSORBABLE SUTURES. THE PATIENT WAS REPORTED DISCHARGED ON THE THIRD DAY POST-INTERVENTION. AT TWO YEARS POST-INTERVENTION, THE PATIENT REMAINED IN COMPLETE CLINICAL REMISSION WITH NO FURTHER UC FLARES AND HAS MAINTAINED STEADY AND STABLE WEIGHT GAIN WITH NORMAL ENERGY LEVELS. [THE PRIMARY AND CORRESPONDING AUTHOR WAS (B)(6).

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300314 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Hospitalization| R