BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4093746 · Received September 16, 2014

    Report

    Report Number
    2951250-2014-00388
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    December 1, 2012
    Report Date
    September 28, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON 22-SEP-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(4) AND PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: LOT NUMBER WAS RECEIVED: 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. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A USABILITY ISSUE AND A REQUEST FOR CONFIRMATION OF QUALITY. THE CASE REFERS ALSO TO AN UNSPECIFIED LACK OF EFFICACY (COIL DID NOT WORK). HOWEVER, LACK OF EFFICACY MAY OCCUR UNDER THE USE OF ANY PRODUCT. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". 7 FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. A15530 (EXPIRATION DATE 30-JUN-2015 AND PRODUCTION DATE JUN-2012), BUT NONE OF THOSE CASES REFER TO SIMILAR ADVERSE TYPES OF EVENTS. NO BATCH SIGNAL COULD BE IDENTIFIED. THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE. IN THIS PARTICULAR CASE, ALSO ADVERSE EVENTS WERE ALS REPORTED OCCURRING AFTER DEVICE REMOVAL. IN SUMMARY, THERE IS NO SUSPICION OF A QUALITY DEFECT BASED ON THE LIMITED AVAILABLE INFORMATION. THE REFERRED USABILITY ISSUE WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PAIN ON HER RIGHT SIDE, BIOPSY SHOWED A COIL PRESENT IN THE LEFT TUBE AND NO COIL PRESENT IN THE RIGHT TUBE AND INCISION GOT INFECTED AND THERE WAS A POCKET THAT FORMED. ALL THE EVENTS WERE CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND ARE LISTED IN ESSURE REFERENCE SAFETY INFORMATION, EXCEPT FOR INCISION GOT INFECTED AND THERE WAS A POCKET THAT FORMED WHICH IS UNLISTED. ABDOMINAL PAIN AND CRAMPING MAY OCCUR WITH ESSURE. PAIN MAY BE A MORE LIKELY OCCURRENCE DURING THE MENSTRUAL PERIOD, DURING AND AFTER SEXUAL INTERCOURSE OR WITH OTHER PHYSICAL ACTIVITY. 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) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS CASE, PATIENT STATED THAT 6 MONTHS AFTER ESSURE INSERTION PROCEDURE, AT HSG (HYSTEROSALPINGOGRAM) TEST, IT WAS FOUND THAT COIL ON RIGHT SIDE DID NOT WORK AND SHE STARTED TO EXPERIENCE PAIN ON HER RIGHT SIDE. HER FALLOPIAN TUBES WERE REMOVED AND BIOPSY SHOWED A COIL PRESENT IN THE LEFT TUBE AND NO COIL PRESENT IN THE RIGHT. CONSIDERING THE POSITIVE TEMPORAL RELATIONSHIP AND THE NATURE OF THE REPORTED EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE INTERVENTION WAS REQUIRED (FALLOPIAN TUBES SURGICALLY REMOVED). AFTER THE INTERVENTION, THE INCISION GOT INFECTED AND THERE WAS A POCKET FORMED, THEREFORE THIS EVENT WAS CONSIDERED RELATED TO ESSURE. ALSO, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS WAS UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION. A REVIEW OF THE MANUFACTURING BATCH RECORD CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. NO FURTHER INFORMATION IS EXPECTED.

    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 IN UNITED STATES ON 21-AUG-2014 WHICH REFERS TO HERSELF. SHE IS A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2012 FOR STERILIZATION. CONSUMER REPORTED THAT INITIALLY SHE SAID SHE WAS FINE AND SIX MONTHS AFTER PROCEDURE, (B)(6) 2013, SHE WENT FOR HSG (HYSTEROSALPINGOGRAM) TEST. SHE DID SAY THE DOCTOR HAD A DIFFICULT TIME INSERTING THE COIL ON THE RIGHT SIDE. HSG SHOWED THAT THE COIL ON RIGHT SIDE DID NOT WORK. DOCTOR SAID SHE COULD GET THE RIGHT SIDE DONE AGAIN AND SHE SAID, NO. CONSUMER WAS TOLD THAT SHE COULD GO FOR AN MRI (MAGNETIC RESONANCE IMAGING) BUT SHE SAID, NO. SHE WANTED HER TUBES TIED INSTEAD. SHE THEN DEVELOPED ALL KINDS OF PROBLEMS INCLUDING PAIN ON HER RIGHT SIDE. SHE READ ON THE INTERNET ABOUT THE PROBLEMS POSTED BY OTHER PEOPLE. SHE THEN THOUGHT HER PROBLEMS WERE RELATED TO ESSURE AND SHE WANTED THE METAL OUT. THREE WEEKS AGO, IN (B)(6) 2014, SHE HAD SURGERY AND THEY REMOVED HER FALLOPIAN TUBES. A BIOPSY SHOWED A COIL PRESENT IN THE LEFT TUBE AND NO COIL PRESENT IN THE RIGHT TUBE. SHE WAS WORRIED IT MIGHT BE IN HER BODY STILL BECAUSE THEY DID NOT LOCATE THE RIGHT COIL. WHEN ASKED, SHE HAD NO MEMORY OF THE COIL EXPELLING FROM HER BODY. NO ADDITIONAL INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION WAS RECEIVED ON 27-AUG-2014 FROM CONSUMER. CONSUMER'S HEIGHT AND WEIGHT WERE PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION WAS RECEIVED ON 29-AUG-2014. SHE DENIED ANY PREVIOUS GYNECOLOGICAL PROBLEM OR PROCEDURES, RELEVANT MEDICAL HISTORY OR CONCURRENT CONDITIONS. ESSURE WAS NOT INSERTED AFTER A PREGNANCY. CONDOMS WERE USED AS BACK-UP CONTRACEPTION. ON UNSPECIFIED DATE, HSG (HYSTEROSALPINGOGRAM) WAS PERFORMED AND SHOWED THAT ONE TUBE WAS BLOCKED AND OTHER TUBE WAS NOT. AFTER DYE (HSG) TEST SHE STARTED EXPERIENCING ALL THE PREVIOUSLY REPORTED EVENTS. SHE WENT TO THE DOCTOR CONCERNING THOSE SYMPTOMS, BUT NO PARTICULAR DIAGNOSIS WAS PROVIDED. NO TREATMENT OR HOSPITALIZATION WAS REQUIRED. SHE STATED THAT SHE DOES NOT KNOW IF THE PAIN SHE EXPERIENCED WAS FROM THE SURGERY (TUBES CUT OFF ON (B)(6) 2014 AND ONE ESSURE COIL (LEFT) WAS REMOVED ALONG WITH TUBES, RIGHT COIL WAS NOT IN THE TUBE AND DID NOT KNOW ABOUT WHERE IT WAS) OR FROM BEFORE. ESSURE WAS REMOVED BY LAPAROSCOPY, THEY WENT THROUGH THE BELLY BUTTON AND PUT 3 HOLES. BIOPSY RESULTS OF THE FALLOPIAN TUBES SHOWED THERE WAS HEMORRHAGING. THERE WERE NO SIGNS AND SYMPTOMS OF INFECTION. SHE WAS STILL RECOVERING FROM PROCEDURE. THE INCISION GOT INFECTED AND THERE WAS A POCKET FORMED. SHE BELIEVES THE CONDITION WAS CAUSED BY ESSURE BECAUSE SHE NEVER HAD THOSE SYMPTOMS UNTIL ESSURE IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT WAS RECEIVED ON 02-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: THE REPORTED ADVERSE EVENTS ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. THE CASE REFERS ALSO TO A USABILITY ISSUE AND AN UNSPECIFIED LACK OF EFFICACY (COIL DID NOT WORK). HOWEVER, LACK OF EFFICACY MAY OCCUR UNDER THE USE OF ANY PRODUCT. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NEITHER A TECHNICAL BATCH EVALUATION NOR A 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 SUSPICION OF A QUALITY DEFECT BASED ON THE LIMITED AVAILABLE INFORMATION. THE REFERRED USABILITY ISSUE WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. CORRECTION 08-SEP-2014 FOLLOWING COMPANY INTERNAL CODING REVIEW: THE EVENT INCISION GOT INFECTED AND THERE WAS A POCKET THAT FORMED WAS SPLIT AND RECODED TO INCISION SITE INFECTION (NON-SERIOUS) AND INCISION SITE ABSCESS (SERIOUS EVENT). FOLLOW-UP INFORMATION WAS RECEIVED ON 08-SEP-2014 VIA ESSURE HEALTH CARE PROVIDER GENERAL QUESTIONNAIRE. THIS CASE IS NOW MEDICALLY CONFIRMED. SHE DENIED ANY PREVIOUS GYNECOLOGICAL INTERVENTIONS. MEDICAL HISTORY INCLUDED FIBROIDS SMALL AND RENAL CANCER. ON (B)(6) 2012 ESSURE LOT NUMBER A15530 WAS INSERTED. THE INSERTION WAS CONSIDERED DIFFICULT DUE TO DIFFICULT RELEASE OF DEVICE ON THE RIGHT SIDE. SHE WAS NOT ON POSTPARTUM STATE. ANALGESIA (NORCO, VALIUM) WAS APPLIED DURING INSERTION. CERVICAL DILATATION, SOUNDING AND GENERAL ANESTHESIA WERE NOT APPLIED DURING INSERTION. THE VISUALIZATION OF THE TUBAL OSTIUM WAS EASY. FLUID LOSS WAS LESS THAN 1500CC AND THE PROCEDURE DID NOT TAKE MORE THAN 20 MINUTES. ON (B)(6) 2013 HSG (HYSTEROSALPINGOGRAM) WAS PERFORMED. CONDOMS WERE USED AS BACK-UP CONTRACEPTION. MRI PRIOR TO SALPINGECTOMY WAS OFFERED BUT THE PATIENT REFUSED. HOSPITALIZATION WAS NOT REQUIRED. THERE WAS NO CONDITION OTHER THAN DEVICE FAILURE ON THE RIGHT SIDE. ON (B)(6) 2014 LAPAROSCOPIC BILATERAL SALPINGECTOMY WAS PERFORMED. THE PATIENT REQUESTED THE REMOVAL BECAUSE SHE WAS WORRIED SHE WAS HAVING PAIN RELATED TO POSSIBLE PERFORATION ON THE RIGHT SIDE. THERE WERE NO PATHOLOGY RESULTS. DURING SURGERY IT WAS FOUND THAT LEFT WAS PRESENT IN TUBE WITH NO PERFORATION AND THERE WAS NO EVIDENCE OF THE OTHER ESSURE DEVICE IN THE TUBE OR ELSEWHERE. PATIENT HAS NOT BEEN SEEN FOR HER POST-OPERATIVE APPOINTMENT AND THEREFORE OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR STERILIZATION AND EXPERIENCED PAIN ON HER RIGHT SIDE, BIOPSY SHOWED A COIL PRESENT IN THE LEFT TUBE AND NO COIL PRESENT IN THE RIGHT TUBE AND INCISION GOT INFECTED AND THERE WAS A POCKET THAT FORMED. ALL THE EVENTS WERE CONSIDERED SERIOUS, DUE TO MEDICAL IMPORTANCE AND ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT FOR INCISION GOT INFECTED AND THERE WAS A POCKET THAT FORMED WHICH IS UNLISTED. ABDOMINAL PAIN AND CRAMPING MAY OCCUR WITH ESSURE. PAIN MAY BE A MORE LIKELY OCCURRENCE DURING THE MENSTRUAL PERIOD, DURING AND AFTER SEXUAL INTERCOURSE OR WITH OTHER PHYSICAL ACTIVITY. 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) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS CASE, PATIENT STATED THAT 6 MONTHS AFTER ESSURE INSERTION PROCEDURE, AT HSG (HYSTEROSALPINGOGRAM) TEST, IT WAS FOUND THAT COIL ON RIGHT SIDE DID NOT WORK AND SHE STARTED TO EXPERIENCE PAIN ON HER RIGHT SIDE. HER FALLOPIAN TUBES WERE REMOVED AND BIOPSY SHOWED A COIL PRESENT IN THE LEFT TUBE AND NO COIL PRESENT IN THE RIGHT. CONSIDERING THE POSITIVE TEMPORAL RELATIONSHIP AND THE NATURE OF THE REPORTED EVENTS, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE INTERVENTION WAS REQUIRED (FALLOPIAN TUBES SURGICALLY REMOVED). AFTER THE INTERVENTION, THE INCISION GOT INFECTED AND THERE WAS A POCKET FORMED, THEREFORE, THIS EVENT WAS CONSIDERED RELATED TO ESSURE. ALSO, NON-SERIOUS EVENTS WERE REPORTED. AN INITIAL PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND WAS UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION. UPON RECEIPT OF FOLLOW-UP INFORMATION ESSURE LOT NUMBER WAS PROVIDED, AND THUS AN UPDATED PTC ANALYSIS IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573135 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A15530, A15630-INVALID

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R NORCO| NORCO| NORCO| NORCO (VICODIN)| VALIUM (DIAZEPAM)| VALIUM [DIAZEPAM]| VALIUM [DIAZEPAM]| VALIUM [DIAZEPAM]| ZOLOFT| ZOLOFT| ZOLOFT| VALIUM (DIAZEPAM)