BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1675933 · Received May 6, 2010

    Report

    Report Number
    3005099803-2010-02081
    Event Type
    Injury
    Date Received
    May 6, 2010
    Report Date
    April 13, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE WAS PERFORMED IN (B)(6) OF 2008 (EXACT DATE UNKNOWN) USING A PINNACLE ANTERIOR/APICAL PFR KIT. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION FOLLOWING THE PROCEDURE. PER EMAIL FROM PHYSICIAN: "I HAVE A ANTERIOR PINNACLE PATIENT WITH A SMALL PERSISTANT [SIC] MESH EXPOSURE THAT DID NOT RESOLVE W/ AN OFFICE OVERSEW AND TRIM. SHE HAS BEEN ON E2 FOR SEVERAL MONTHS AND IT DOESN'T WANT HEAL. I AM CONSIDERING A TRIP TO THE OR TO BETTER ACCESS AND EXCISE IT.... (B)(6) [THE PATIENT] IS A (B)(6) WOMAN WHO HAS BEEN FOLLOWED FOR THE LAST SEVERAL MONTHS FOR PERMANENT MESH EXPOSURE IN THE ANTERIOR COMPARTMENT. SHE HAS HAD TWO OVER-SEWINGS, WHICH INCLUDED SOME TRIMMING OF THE MESH. HER LAST VISIT IN (B)(6) 2009 SHOWED GRANULATION COVERING THE MESH VOID. SINCE THAT TIME, SHE HAS NOT EXAMINED HER VAGINAL SURFACE WITH A FINGER, OR ATTEMPTED INTERCOURSE. SHE HAS TAKEN HER PREMARIN 0.3 MG P.O. DAILY WITHOUT PROBLEMS. WE DISCUSSED THE HEALING PROCESS, GRANULATION TISSUE, FOREIGN BODY REACTION, AND THE COURSE OF HER MESH EXPOSURE. SHE NOTES NO FRANK BLEEDING, ONLY RARE BOUTS OF SMALL SPOTTING OR PINKISH DISCHARGE. SHE HAS NO FEVERS OR CHILLS, NOR DOES SHE HAVE ANY FOUL VAGINAL DISCHARGE. PHYSICAL EXAMINATION: VITAL SIGNS: (B)(6), (B)(6), BLOOD PRESSURE 110/60, PULSE 80, RESPIRATIONS 12. ABDOMEN: SOFT, NONTENDER. PELVIC: EXTERNAL GENITALIA, NO INGUINAL LYMPHADENOPATHY. CLITORAL AND LABIAL FOLDS, WELL FORMED. NO INTROITAL TENDERNESS. NORMAL INTROITAL RING. VAGINA: A THOROUGH EXAM WAS DONE USING A HALF OF A STANDARD SIMS' SPECULUM TO DEPRESS THE POSTERIOR VAGINA. WE VISUALIZED THE ENTIRE LENGTH OF THE VAGINA, INCLUSIVE OF THE REPAIR AREAS. AT 2 O'CLOCK, THE PRIOR AREA (12X7MM) OF MESH EXPOSURE WAS PARTIALLY COVERED OVER WITH A 2 TO 3 MM MOUND OF GRANULATION TISSUE. THERE WAS A BRISTLE OR TWO AT THE FAR POSTERIOR EDGE. THESE WERE TRIMMED. THERE IS STILL NO CORNIFICATION OF TISSUE YET. THE GRANULATION TISSUE WAS STANCHED WITH A SILVER NITRATE STICK." CURRENTLY, THE PHYSICIAN HAS NOT PERFORMED ANY ADDITIONAL SURGERY, BUT WILL "PROBABLY" OPERATE AND/OR PROVIDE FURTHER INTERVENTION. THE PATIENT'S EROSION IS REPORTEDLY "STILL RESOLVING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention