BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEROFORM® TISSUE EXPANDER SYSTEM, MEDIUM, V3.0

    MDR report key: 7371546 · Received March 26, 2018

    Report

    Report Number
    3014023351-2018-00001
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    August 2, 2018
    Report Date
    February 24, 2018
    Manufacturer
    AIRXPANDERS, INC.
    Product Code
    PQN
    PMA / PMN Number
    K170075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE SLOW VALVE CLOSURE (B)(4) WAS VISCOUS MATERIAL LOCATED INSIDE THE RESERVOIR ASSEMBLY. THE VISCOUS MATERIAL SOURCE WAS ADHESIVE PARTICULATE THAT DISLODGED AND MIGRATED TO THE BACK SIDE OF THE SPRING PAD SUBASSEMBLY, CAUSING THE VALVE TO CLOSE SLOWLY. THE VALVE WAS SLOW TO RETRACT, LEADING TO LONG CLOSURE TIMES AND EXCESS GAS RELEASE. CONCLUSION: VISCOUS MATERIAL, ADHESIVE PARTICULATE, LED TO SLOW CLOSURE OF THE VALVE. THE SOURCE OF THE ADHESIVE PARTICULATE WAS THE HYDREL PAD ADHESIVE. THE PROCESS ERROR THAT WE BELIEVE LED TO THE PRESENCE OF THE VISCOUS MATERIAL HAS NOW BEEN CORRECTED VIA AN ADDITIONAL SCREENING STEP.

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION HAS NOT YET CONCLUDED. PRELIMINARY INVESTIGATION SHOWS THAT THIS REPORT WAS NOT AN UNCONTROLLED EXPANSION, BUT INSTEAD A SLOW CLOSING VALVE. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON 24-FEB-2018 IT WAS REPORTED THAT ON (B)(6) 2018 THE LEFT EXPANDER "FILLED UNCONTROLLABLY CAUSING SUBSTANTIAL PAIN AND CHANGE IN BREAST SIZE" DURING EXPANSION AT HOME. THE PATIENT WAS ADMINISTERING ONE DOSE (10 CC) EVERY THREE DAYS ACCORDING TO THE SURGEON'S REPORT. THE PATIENT PRESSED THE DOSAGE CONTROLLER FOR A SINGLE DOSE AND FELT THE EXPANDER CONTINUE EXPANDING. THE SURGEON REPORTS THE PATIENT WAS DIRECTED TO THE ER WHERE THE ER DOCTOR "USED A NEEDLE TO PUNCTURE AND DEFLATE THE DEVICE". THE SURGEON STATES THAT TREATMENT WAS PROCEEDING NORMALLY FOR THIS PATIENT PRIOR TO THIS EVENT. THE PATIENT HAD ATTENDED 6 OR 7 POST-OPERATION VISITS AND NO CONCERNS WERE BROUGHT UP AT THESE TIMES. CHEMOTHERAPY HAD BEEN A PART OF THE PATIENT TREATMENT PLAN, BUT HAD CONCLUDED PRIOR TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212098 AEROFORM® TISSUE EXPANDER SYSTEM, MEDIUM, V3.0 CARBON DIOXIDE GAS CONTROLLED TISSUE EXPANDER PQN AIRXPANDERS, INC. FGS-0012-02 F03062

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention