BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVIC MESH

    MDR report key: 7916321 · Received September 27, 2018

    Report

    Report Number
    3003990090-2018-00147
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    August 1, 2018
    Report Date
    September 27, 2018
    Manufacturer
    CALDERA MEDICAL INC.
    Product Code
    OTN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INFORMATION AS PRESENTED, IT IS UNKNOWN WHETHER THE ISSUE AS DESCRIBED IS RELATED TO THE DEVICE, PATIENT MEDICAL HISTORY, OR SURGICAL TECHNIQUE. THE SURGEON FEELS THAT THE ISSUE IS BEING CAUSED BY THE THICKNESS OF THE CALDERA MEDICAL INC. (CMI) INSTRUMENT WIRE THAT THE SURGEON USED (4.0MM) AND FEELS THAT THIS DIAMETER CAUSES INCREASED INTRA OPERATIVE BLEEDING DURING SURGERY AND LATER RESULTING IN EROSIONS/EXPOSURES. HOWEVER, SHE ALSO STATES THAT SHE WAS HAVING THE SAME ISSUES WITH A COMPETITOR INSTRUMENT WITH A THINNER DIAMETER (BOSTON SCIENTIFIC 3.3MM). PER THE SUBJECT MATTER EXPERT (SME), IT APPEARS UNLIKELY THAT THE THICKNESS OF THE CMI WIRE IS A CONTRIBUTING FACTOR TO THE ISSUE SINCE THE SURGEON HAS EXPERIENCED THE SAME ADVERSE EVENT USING A SMALLER DIAMETER INSTRUMENT AS WELL. THE SALES REP REPORTS THAT THIS IS A HIGH VOLUME SURGEON WITH MUCH EXPERIENCE USING CMI PRODUCTS. OTHER POTENTIAL ROOT CAUSES INCLUDE HEIGHTENED AWARENESS BY THE SURGEON OF THIS TYPE OF ADVERSE EVENT GIVEN THE HIGH VOLUME SHE TYPICALLY PERFORMS, PATIENT PHYSIOLOGY AND DEMOGRAPHICS (WHICH ARE UNKNOWN IN THIS CASE), AND THE SURGEON'S STANDARD POST-OPERATIVE CARE REGIMEN FOR THIS TYPE OF ISSUE. IN THIS CASE THE SURGEON WAS ABLE TO TRIM THE MESH AND SEND THE PATIENT HOME. NO FURTHER INFORMATION IS AVAILABLE WITH REGARDS TO DR. (B)(6)'S NORMAL POST-OPERATIVE CARE REGIMEN. MESH EROSION/EXPOSURE/EXPLANT IS A KNOWN RISK WITH THE USE OF ALL MESH PROCEDURES AND MAY BE DUE TO DEVICE MALFUNCTION, SURGICAL PROCEDURE, OR PATIENT MEDICAL HISTORY. EXPOSURE IS LABELED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) WARNING SECTION. WHEN USED CORRECTLY AS INTENDED, THE CLINICAL BENEFIT TO THE PATIENT FOR THE TREATMENT OF STRESS URINARY INCONTINENCE OUTWEIGHS THIS RISK. WITHOUT THE PRODUCT TYPE, LOT NUMBER, OR ACTUAL RETURN OF PRODUCT, INVESTIGATION CANNOT BE COMPLETED. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    SALES REP REPORTS THAT A SURGEON HAS EXPERIENCED 3 MESH EXPOSURES DURING FOLLOW-UP IN THE PAST MONTH WITH HER PATIENTS. THE IMPLANTATION DATES, LOT NUMBERS, AND SPECIFIC IMPLANT AND INSTRUMENT MODELS ARE UNKNOWN. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. PER THE REP, THE SURGEON STATES THAT SHE TRIMMED THE MESH AND DID NOT EXPLANT. THE SURGEON BELIEVES THE ISSUE IS BEING CAUSED BY THE THICKNESS OF THE CMI INSTRUMENT WIRE THAT THE SURGEON USED (4.0MM) AND FEELS THAT THIS DIAMETER CAUSES INCREASED INTRA OPERATIVE BLEEDING DURING SURGERY AND LATER RESULTING IN EROSIONS/EXPOSURES. HOWEVER, SHE ALSO STATES THAT SHE WAS HAVING THE SAME ISSUES WITH A COMPETITOR INSTRUMENT WITH A THINNER DIAMETER (BOSTON SCIENTIFIC 3.3MM). PER THE SUBJECT MATTER EXPERT (SME), IT APPEARS UNLIKELY THAT THE THICKNESS OF THE CMI WIRE IS A CONTRIBUTING FACTOR TO THE ISSUE SINCE THE SURGEON HAS EXPERIENCED THE SAME ADVERSE EVENT USING A SMALLER DIAMETER INSTRUMENT AS WELL. THE SALES REP REPORTS THAT THIS IS A HIGH VOLUME SURGEON WITH MUCH EXPERIENCE USING CMI PRODUCTS. OTHER POTENTIAL ROOT CAUSES INCLUDE HEIGHTENED AWARENESS BY THE SURGEON OF THIS TYPE OF ADVERSE EVENT GIVEN THE HIGH VOLUME SHE TYPICALLY PERFORMS, PATIENT PHYSIOLOGY AND DEMOGRAPHICS (WHICH ARE UNKNOWN IN THIS CASE), AND THE SURGEON'S STANDARD POST-OPERATIVE CARE REGIMEN FOR THIS. NO FURTHER INFORMATION HAS BEEN REPORTED. MESH EROSION/ EXPOSURE/ EXPLANT IS A KNOWN RISK WITH THE USE OF ALL MESH PROCEDURES AND MAY BE DUE TO DEVICE MALFUNCTION, SURGICAL PROCEDURE, OR PATIENT MEDICAL HISTORY. EXPOSURE IS LABELED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) WARNING SECTION. WHEN USED CORRECTLY AS INTENDED, THE CLINICAL BENEFIT TO THE PATIENT FOR THE TREATMENT OF STRESS URINARY INCONTINENCE OUTWEIGHS THIS RISK. THIS SUBMISSION IS MDR 2 OF THE 3 REPORTED ADVERSE EVENTS OF EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755191 PELVIC MESH OTN CALDERA MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other