BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4151692 · Received October 8, 2014

    Report

    Report Number
    2951250-2014-00417
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    January 1, 2004
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION FROM 26-MAY-2016. THE CASE (B)(4) WAS IDENTIFIED AS DUPLICATE OF THIS CASE AND ALL INFORMATION WAS TRANSFERRED TO THIS REMAINING CASE. DEVICE WAS IMPLANTED IN (B)(6) 2004 (DISCREPANT WITH INFORMATION PREVIOUSLY REPORTED). TROUBLE DURING IMPLANTATION, PERFORATED TUBE. AS OF (B)(6) 2005, DEVICE MIGRATED OUT OF FALLOPIAN TUBE. LAPAROSCOPY AND LEFT SALPINGECTOMY, DEVICE NOT LOCATED ((B)(6) 2005). BLADDER LIFT WITH TAPE AND NOVASURE ENDOMETRIAL ABLATION ((B)(6) 2009). CYKLOKAPRON TO HELP WITH EXCESS MENSTRUAL BLEEDING PRIOR TO ABLATION. CORRECTION (26-MAY-2016) FOLLOWING COMPANY INTERNAL REVIEW: SINCE THE CASE (B)(4) WAS CONSIDERED AS MEDICALLY CONFIRMED, A NEW REPORTER WAS ADDED. THIS CASE WAS CONSIDERED AS MEDICALLY CONFIRMED. CORRECTION (26-MAY-2016) FOLLOWING COMPANY INTERNAL REVIEW: THE CASE WAS NOT CONSIDERED MEDICALLY CONFIRMED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO WAS SUBMITTED TO ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND DURING THIS PROCEDURE DEVICE PERFORATED FALLOPIAN TUBE. LATER IT WAS DISCOVERED THE DEVICE MIGRATED OUT OF FALLOPIAN TUBE; SHE WAS SUBMITTED TO A LAPAROSCOPY AND LEFT SALPINGECTOMY AND ESSURE COULD NOT BE LOCATED DURING LAPAROSCOPY. THESE EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND ARE LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. FALLOPIAN TUBE PERFORATION WITH ESSURE MAY OCCUR, MOST OFTEN DURING INSERTION. ALSO, DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES; THIS MOVEMENT COULD BE AN EXPULSION, MIGRATION OR OCCUR AS A RESULT OF A FALLOPIAN TUBE PERFORATION. IN THIS PARTICULAR CASE, THE REPORTED FALLOPIAN TUBE PERFORATION COULD HAVE LED TO ESSURE MIGRATION. THEREFORE, ALL REPORTED EVENTS WERE CONSIDERED AS RELATED TO ESSURE. THIS CASE WAS REGARDED AS INCIDENT SINCE A SURGICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS (PTC) THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. NO FURTHER INFORMATION IS EXPECTED (FURTHER CONTACT WAS DENIED BY CONSUMER).

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (B)(4) IN (B)(6) ON 11-SEP-2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2004. CONSUMER STATED THAT DEVICE MIGRATED OUT OF FALLOPIAN TUBE (DISCOVERED ON (B)(6) 2005). LOCATION UNKNOWN. PAIN SINCE DATE OF IMPLANT. PHYSICIAN HAD TROUBLE IMPLANTING DEVICE, DEVICE PERFORATED FALLOPIAN TUBE, WAS BACKED OUT AND TRIED AGAIN AFTER NITROGLYCERIN WAS ADMINISTERED. NUMBER OF IMPLANTS UNKNOWN AT THAT TIME. EMERGENCY ROOM VISIT ON (B)(6) 2004 FOR PAIN. SHE WAS TREATED FOR SUSPECTED INFECTION. SO FAR SHE HAS HAD A LEFT SALPINGECTOMY ((B)(6) 2005), DEVICE WAS UNABLE TO BE LOCATED DURING LAPAROSCOPY, A BLADDER LIFT WITH TAPE ((B)(6) 2009), NOVASURE ENDOMETRIAL ABLATION ((B)(6) 2009). CYKLOKAPRON MEDICATION TO HELP WITH EXCESS MENSTRUAL BLEEDING PRIOR TO ABLATION. HYSTEROSCOPY, CYTOSCOPY (B)(6) 2009. SHE WAS DIAGNOSED WITH CELIAC ON (B)(6) 2011. ALLERGIES TO MULTIPLE DRUGS, FOODS, INDOOR AND OUTDOOR ENVIRONMENTAL. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT WAS RECEIVED ON 19-SEP-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. HOWEVER, THE REPORTED ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. THE AE CASE REFERS ALSO TO A USABILITY ISSUE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. THE REPORTED USABILITY ISSUE WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED DEVICE MIGRATED OUT OF FALLOPIAN TUBE, COULD NOT BE LOCATED DURING LAPAROSCOPY AND DEVICE PERFORATED FALLOPIAN TUBE. THESE EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. UTERINE PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE). UTERINE PERFORATION WITH ESSURE MAY OCCUR, MOST OFTEN DURING INSERTION. ALSO, DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES, THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS OR OUT OF THE BODY), MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY) OR OCCUR AS A RESULT OF A FALLOPIAN TUBE PERFORATION. IN THIS PARTICULAR CASE, IT WAS REPORTED THAT PHYSICIAN HAD TROUBLE IMPLANTING THE DEVICE AND IT PERFORATED FALLOPIAN TUBE, THIS PERFORATION COULD HAVE CONTRIBUTED FOR THE REPORTED ESSURE MIGRATION. CONSIDERING THE ABOVE MENTION INFORMATION AND THE POSITIVE TEMPORAL RELATIONSHIP THESE EVENTS WERE CONSIDERED AS RELATED TO ESSURE. THIS CASE WAS REGARDED AS INCIDENT SINCE A LAPAROSCOPY AND LEFT SALPINGECTOMY WERE REQUIRED (DEVICE WAS UNABLE TO BE LOCATED DURING LAPAROSCOPY). ALSO, NON-SERIOUS EVENTS WERE REPORTED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS (PTC) THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. NO FURTHER INFORMATION IS EXPECTED (FURTHER CONTACT WAS DENIED BY CONSUMER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633277 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other