BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERITAS COLLAGEN MATRIX

    MDR report key: 3747274 · Received April 12, 2014

    Report

    Report Number
    2032282-2014-00061
    Event Type
    Injury
    Date Received
    April 12, 2014
    Date of Event
    May 8, 2006
    Report Date
    March 31, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K062915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT SUMMARY: VERITAS COLLAGEN MATRIX IS INTENDED FOR USE IN RECONSTRUCTION OF THE PELVIC FLOOR EXCLUDING TRANSVAGINAL PELVIC ORGAN PROLAPSE AND FOR USE IN THE REPAIR OF RECTAL PROLAPSE EXCLUDING RECTOCELE. VERITAS COLLAGEN MATRIX IS NOT DESIGNED, SOLD, OR INTENDED FOR USE EXCEPT AS INDICATED; DOING SO MAY RESULT IN SURGICAL COMPLICATIONS. WHEN CLINICAL CIRCUMSTANCES REQUIRE IMPLANTATION IN A SITE THAT IS CONTAMINATED OR INFECTED, APPROPRIATE LOCAL AND/OR SYSTEMIC MEASURES SHOULD BE TAKEN TO MANAGE THE CONTAMINATION/INFECTION. AS WITH ANY SURGICAL PROCEDURE, ADVERSE REACTIONS ARE POSSIBLE AND INCLUDE, BUT ARE NOT LIMITED TO: INFECTION, REJECTION, EROSION, AND ALLERGIC REACTION. THE UNSPECIFIED INJURIES OF THE PATIENT ARE UNLIKELY THE RESULT OF THE USE OF VERITAS. THE INDICATION FOR USE STATEMENT FOR THE MEDICAL DEVICE CLEARLY CONTRAINDICATES THE USE OF VERITAS IN TRANSVAGINAL PELVIC ORGAN PROLAPSE, WHICH APPEARS TO BE THE CASE IN THE REPORTED PATIENT. THE INSTRUCTIONS FOR USE ALSO APPROPRIATELY STATES THAT VERITAS COLLAGEN MATRIX IS NOT DESIGNED, SOLD, OR INTENDED FOR USE EXCEPT AS INDICATED; DOING SO MAY RESULT IN SURGICAL COMPLICATIONS. THE LABELING OF THE MEDICAL DEVICE CAPTURES ACCURATELY THE POTENTIALS WARNINGS, RISKS AND HARMS RELATIVE TO THE USE OF VERITAS IN PELVIC FLOOR RECONSTRUCTION. GIVEN THAT THE LEGAL LETTER RECEIVED BY BAXTER/SYNOVIS DOES NOT CONTAIN ANY DETAILS ON THE NATURE AND SEVERITY OF THE ¿INJURIES¿ CLAIMED, A MEDICAL ANALYSIS OF A POTENTIAL CAUSAL RELATIONSHIP WITH THE USE OF VERITAS COLLAGEN MATRIX IS NOT POSSIBLE. FURTHER DETAILS REQUIRING INFORMATION ON SYMPTOMS AND COMPLICATIONS BEFORE FIRST SURGERY, AFTER FIRST SURGERY AND AFTER SECOND SURGERY (IN WHICH VERITAS HAS BEEN USED) ARE REQUIRED. BAXTER LEGAL IS CURRENTLY FOLLOWING-UP FOR ADDITIONAL CLINICAL CASE INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED THROUGH BAXTER LEGAL, HOWEVER NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. BAXTER SYNOVIS COMPLETED THE INVESTIGATION. AS NO SAMPLE OR LOT NUMBER WAS PROVIDED, SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. NO TREND WAS IDENTIFIED. PER SYNOVIS, ADDITIONAL INVESTIGATION IS NOT REQUIRED AT THIS TIME BECAUSE BASED ON THE DETAILS OF THE COMPLAINT, IT IS NOT EVIDENT THAT THE PRODUCT RESULTED IN THE PATIENT¿S ISSUES. THE CUSTOMER COMPLAINT DOES NOT CONTAIN ANY DETAILS ON THE NATURE AND SEVERITY OF THE INJURIES CLAIMED OR THE STATUS OF THE VERITAS PATCH AFTER THE SURGERY; THEREFORE A ROOT CAUSE ANALYSIS RELATED TO THE US OF VERITAS COLLAGEN MATRIX IS NOT POSSIBLE. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    A PRODUCT LITIGATION CASE WAS REPORTED TO BAXTER LEGAL IN REGARDS TO VERITAS COLLAGEN MATRIX. PATIENT¿S INITIALS: (B)(6). GENDER: FEMALE. AS REPORTED DATE OF IMPLANT OF VERITAS: (B)(6) 2006. INDICATION FOR SURGERY: TREAT CONDITIONS RELATED TO PELVIC HEALTH OF WOMEN, PRIMARILY STRESS URINARY INCONTINENCE (SUI) AND ALSO PELVIC ORGAN PROLAPSED (POP). PATIENT¿S MEDICAL HISTORY: ON (B)(6) 2003, RECEIVED MEDICAL TREATMENT AT (B)(6) MEDICAL CENTER THAT INCLUDED THE IMPLANTATION OF AMERICAN MEDICAL SYSTEM¿S TRANSVAGINAL MESH PRODUCT (IN-FAST MESH) AS WELL AS MESH MANUFACTURED BY CARBON MEDICAL TECHNOLOGIES. THE SURGERY WAS NOT WHOLLY SUCCESSFUL AND ON (B)(6) 2006, THE PATIENT RECEIVED MEDICAL TREATMENT AT (B)(6) HOSPITAL IN (B)(6), OREGON THAT INCLUDED THE IMPLANTATION OF BOSTON SCIENTIFIC CORPORATION¿S TRANSVAGINAL MESH PRODUCT (OBTRYX MESH) AS WELL AS VERITAS COLLAGEN MATRIX (SYNOVIS SURGICAL INNOVATIONS). NEITHER SURGERY WAS WHOLLY SUCCESSFUL AND THE PATIENT SUFFERS INJURIES AS A RESULT OF THE IMPLANTATION OF ALL PRODUCTS. BELOW IS A SUMMARY OF THE PLAINTIFF¿S COMPLAINTS: DEFENDANTS HAVE UNDERREPORTED AND WITHHELD INFORMATION ABOUT THE PROPENSITY OF THEIR PELVIC MESH PRODUCTS TO FAIL AND CAUSE INJURY AND COMPLICATIONS, AND HAVE MISREPRESENTED THE EFFICACY AND SAFETY OF THESE PRODUCTS, THROUGH VARIOUS MEANS AND MEDIA, ACTIVELY AND INTENTIONALLY MISLEADING THE PUBLIC. DEFENDANTS FAILED TO DESIGN AND ESTABLISH A SAFE, EFFECTIVE PROCEDURE FOR REMOVAL OF THE PELVIC MESH PRODUCTS; THUS, IN THE EVENT OF A FAILURE, INJURY, OR COMPLICATIONS, IT IS IMPOSSIBLE TO EASILY AND SAFELY REMOVE THEIR PELVIC MESH PRODUCTS. DEFENDANTS PROVIDED INCOMPLETE AND INSUFFICIENT TRAINING AND INFORMATION TO PHYSICIANS TO INCREASE THE NUMBER OF PHYSICIANS UTILIZING THEIR PELVIC MESH PRODUCTS, AND THUS INCREASE THE SALES OF THESE PRODUCTS. THE INJURIES, CONDITIONS, AND COMPLICATIONS SUFFERED BY WOMEN, INCLUDING PLAINTIFF, WHO HAVE BEEN IMPLANTED WITH PELVIC MESH PRODUCTS INCLUDE, BUT ARE NOT LIMITED TO, MESH EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA (PAIN DURING SEXUAL INTERCOURSE), BLOOD LOSS, ACUTE AND CHRONIC NERVE DAMAGE AND PAIN, PUDENDAL NERVE DAMAGE, PELVIC FLOOR DAMAGE, CHRONIC PELVIC PAIN, URINARY AND FECAL INCONTINENCE, AND PROLAPSE OF ORGANS. IN MANY CASES, THESE WOMEN HAVE BEEN FORCED TO UNDERGO INTENSIVE MEDICAL TREATMENT, INCLUDING, BUT NOT LIMITED TO, THE USE OF PAIN CONTROL AND OTHER MEDICATIONS, INJECTIONS INTO VARIOUS AREAS OF THE PELVIS, SPINE, AND THE VAGINA, AND SURGERIES TO REMOVE PORTIONS OF THE FEMALE GENITALIA, TO LOCATE AND REMOVE MESH, AND TO ATTEMPT TO REPAIR PELVIC ORGANS, TISSUE, AND NERVE DAMAGE. AT ALL RELEVANT TIMES HEREIN, DEFENDANTS FAILED TO PROVIDE SUFFICIENT WARNINGS AND INSTRUCTIONS THAT WOULD HAVE PUT PLAINTIFF, HER PHYSICIANS, AND THE PUBLIC ON NOTICE OF THE DANGERS AND ADVERSE EFFECTS CAUSED BY IMPLANTATION OF THEIR PELVIC MESH PRODUCTS. THEIR PELVIC MESH PRODUCTS WERE DEFECTIVE AS MARKETED DUE TO INADEQUATE WARNINGS, INSTRUCTIONS, LABELING, AND/OR INADEQUATE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226098 VERITAS COLLAGEN MATRIX MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other