BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUTOPATCH® BOVINE PERICARDIUM

    MDR report key: 18356052 · Received December 19, 2023

    Report

    Report Number
    3002924436-2023-00006
    Event Type
    Injury
    Date Received
    December 19, 2023
    Report Date
    May 20, 2024
    Manufacturer
    TUTOGEN MEDICAL, GMBH
    Product Code
    FTM
    PMA / PMN Number
    K091142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE MAKING FOLLOW-UP ATTEMPTS, NO ADDITIONAL INFORMATION WAS PROVIDED FROM THE AUTHORS. AS NO PRODUCT IDENTIFIERS WERE PROVIDED, TUTOGEN MEDICAL GMBH (TMI),WAS UNABLE TO PERFORM A BATCH DOCUMENTATION ANALYSIS FOR THE TUTOPATCH GRAFTS THAT WERE IMPLANTED IN THE PATIENTS. SOME OF THE DOCUMENTED ADVERSE EVENTS IN THE ARTICLE ARE CONSIDERED SERIOUS DUE TO REPORTED OR SUSPECTED REQUIRED MEDICAL INTERVENTION PROVIDED FOR TREATMENT. ALTHOUGH IMPLANT THERAPY IS HIGHLY SUCCESSFUL AND PREDICTABLE, IT IS NOT WITHOUT POSSIBLE EARLY AND/OR LATE COMPLICATIONS. THE DIFFERENT PATIENT'S COMPLICATIONS THAT DEVELOPED EARLY (WITHIN THE FIRST 60 DAYS POST-OPERATIVELY) OR LATE (AFTER 60 DAYS POST-OPERATIVELY), ARE MOST LIKELY ASSOCIATED WITH A SOURCE OR EVENT EXTRINSIC TO THE TUTOPATCH GRAFT.

    Additional Manufacturer Narrative · 0

    RTI GERMANY'S INVESTIGATION IS IN PROCESS. ONCE THE RESULTS ARE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    RTI SURGICAL, INC. AND TUTOGEN MEDICAL GMBH (TMI), A WHOLLY SUBSIDIARY OF RTI SURGICAL, RECEIVED A COMPLAINT ON 11/23/2023, RESULTING FROM A LITERATURE REVIEW. THE ARTICLE WAS PUBLISHED IN THE JOURNAL OF SPRINGER NATURE AND INTERNATIONAL SOCIETY OF AESTHETIC PLASTIC SURGERY 2023 TITLED, " IMPLANT-BASED BREAST RECONSTRUCTION WITH BOVINE PERICARDIUM: OUR APPROACH USING TUTOPATCH® AND REVIEW OF LITERATURE". OF NOTE, NO UNIQUE SERIAL IDS OF THE TUTOPATCH® GRAFTS THAT WERE UTILIZED IN THE STUDY WERE DOCUMENTED IN THE ARTICLE. PER THE INSTRUCTIONS FOR USE (IFU), TUTOPATCH® GRAFTS ARE SUPPOSED TO BE USED FOR DURA REPLACEMENT FOR CRANIOTOMY PROCEDURES. THE ARTICLE STATED THAT 103 PATIENTS (COMPRISING 114 BREASTS) UNDERWENT IMMEDIATE IMPLANT-BASED BREAST RECONSTRUCTIONS USING BOVINE PERICARDIUM BOVINE MATRIX. THE PROCEDURES WERE PERFORMED BY THE SAME SURGICAL TEAM BETWEEN APRIL 2018 AND MAY 2023. TUTOPATCH® BOVINE PERICARDIUM GRAFTS WERE IMPLANTED FOR THE BREAST RECONSTRUCTIONS. POST-OPERATIVE COMPLICATIONS WERE CATEGORIZED INTO EARLY AND LATE COMPLICATIONS. FOR EARLY COMPLICATIONS (WITHIN THE FIRST 60 DAYS), THE FOLLOWING FACTORS WERE CONSIDERED: ISCHEMIA OF MASTECTOMY FLAPS, SKIN NECROSIS (MINOR IF PARTIAL THICKNESS, REQUIRING CONSERVATIVE TREATMENTS; MAJOR IF FULL THICKNESS, NECESSITATING SURGICAL REVISION), BLEEDING, HEMATOMA FORMATIONS, WOUND DEHISCENCE. RESULTS INDICATED THAT ONE PATIENT DEVELOPED WOUND DEHISCENCE. ONE PATIENT DEVELOPED AN INFECTION. FOUR PATIENTS DEVELOPED FLAP ISCHEMIA (SPONTANEOUS RESOLUTION). ONE PATIENT DEVELOPED SKIN NECROSIS. ONE PATIENT DEVELOPED BLEEDING. TWO PATIENTS DEVELOPED A HEMATOMA. THE LATE POST-OPERATIVE COMPLICATIONS (AFTER 60 DAYS), CONSISTED OF SEROMA FORMATION, PRESENCE OF RIPPLING, ANIMATION DEFORMITY, CAPSULAR CONTRACTURE, WOUND DEHISCENCE, AND IMPLANT ROTATION. RESULTS INDICATED THAT ONE PATIENT DEVELOPED WOUND DEHISCENCE. EIGHT PATIENTS DEVELOPED A SEROMA. TWO PATIENTS DEVELOPED RIPPLING. TWO PATIENTS DEVELOPED ANIMATION DEFORMITY. ONE PATIENT DEVELOPED CAPSULAR CONTRACTURE. ONE PATIENT DEVELOPED ROTATION OF THE IMPLANT. IN CONCLUSION, THE PRESERVING MATERIAL CHARACTERISTICS OF THE TUTOPATCH® GRAFT EFFECTIVELY RESIST TENSILE FORCES DURING SOFT TISSUE REPAIR WAS OF UTMOST IMPORTANCE. TUTOPATCH® BOVINE PERICARDIUM GRAFTS STOOD OUT AS A PROMISING OPTION IN THIS REGARD. STUDIES HAVE DEMONSTRATED THAT TUTOPATCH® BOVINE PERICARDIUM GRAFTS RETAIN THE NATIVE MULTI-DIRECTIONAL NETWORK OF COLLAGEN FIBERS, WHICH IS VITAL FOR OPTIMAL TISSUE REPAIR. TUTOPATCH® BOVINE PERICARDIUM HAS REVEALED SIGNIFICANTLY HIGHER VALUES FOR UNIAXIAL MAX LOAD, ULTIMATE TENSILE STRENGTH (UTS), AND MODULUS. THESE FINDINGS INDICATE THAT TUTOPATCH® EXHIBITS SUPERIOR MECHANICAL PROPERTIES, MAKING IT WELL-SUITED FOR APPLICATIONS WHERE DURABILITY AND RESILIENCE ARE ESSENTIAL FOR SUCCESSFUL OUTCOMES IN SOFT TISSUE REPAIRS. TUTOPATCH® GRAFTS DEMONSTRATES CONSIDERABLE ADVANTAGES AS A BIOMATERIAL FOR BREAST RECONSTRUCTION, RENDERING IT AN APPEALING CHOICE IN CLINICAL PRACTICE. THE EFFICACY OF TUTOPATCH® IN BREAST RECONSTRUCTION HAS BEEN DEMONSTRATED, AND ITS ADOPTION AS AN ALTERNATIVE TO CONVENTIONAL METHODS HOLDS PROMISE. BASED ON ACCUMULATED CLINICAL EXPERIENCE, TUTOPATCH® GRAFTS CAN BE REGARDED AS A SAFE AND EFFECTIVE BIOMATERIAL FOR BREAST RECONSTRUCTION. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO RTI FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497269 TUTOPATCH® BOVINE PERICARDIUM TUTOPATCH® FTM TUTOGEN MEDICAL, GMBH
    2230986 TUTOPATCH® BOVINE PERICARDIUM TUTOPATCH® FTM TUTOGEN MEDICAL, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other