BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8878000 · Received August 9, 2019

    Report

    Report Number
    2951250-2019-04608
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    August 1, 2012
    Report Date
    September 17, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/FRACTURED ESSURE DEVICE FRAGMENT') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RESTLESS LEG SYNDROME, HEAVY PERIODS, NOCTURIA AND SMOKER. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPOTHYROIDISM, ASTHMA, HYPERTENSION, GERD, DIAPHRAGM, DYSMENORRHEA, CRAMP IN LOWER ABDOMEN, MYOMECTOMY, FLANK PAIN, GALLSTONES, KIDNEY STONE, LEFT LOWER QUADRANT PAIN, NAUSEA AND RADICULITIS LUMBOSACRAL. CONCOMITANT PRODUCTS INCLUDED CANNABIS SATIVA (MARIJUANA), ESOMEPRAZOLE SINCE 1997, ETHINYLESTRADIOL;ETHYNODIOL DIACETATE (ZOVIA) SINCE 2006 TO JULY 2012, FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE (ADVAIR) SINCE 2007, LEVOTHYROXINE SINCE 1992, MELOXICAM SINCE (B)(6) 2017, MONTELUKAST SODIUM (SINGULAIR) SINCE 2007, SALBUTAMOL (ALBUTEROL) SINCE 2007 AND VERAPAMIL FROM JUNE 2012 TO DECEMBER 2013. IN JANUARY 2012, THE PATIENT HAD ESSURE INSERTED. IN AUGUST 2012, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), PELVIC PAIN ("PHYSICAL PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). THE PATIENT WAS TREATED WITH BUPROPION, SERTRALINE AND SURGERY (DAVINCI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND UNDERWENT ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, MENORRHAGIA, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THIS RESULTED IN 3 COILS BEING SEEN AT THE OSTIUM. THE PROCEDURE WAS REPEATED ON THE PATIENT'S RIGHT SIDE. THIS TIME 4 COILS WERE SEEN WITHIN THE UTERINE CAVITY. CURRENT WEIGHT 236 LBS. DISCREPANCY NOTED IN INSERTION DATES-ESSURE INSERTION DATE- JAN-2012, (B)(6) 2012 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.7 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. BOTH FALLOPIAN TUBES WERE BLOCKED SUCCESSFULLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN,DEVICE BREAKAGE LOT NUMBER: 952114 MANUFACTURE DATE: 2012-02 EXPIRATION DATE: 2015-02 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/FRACTURED ESSURE DEVICE FRAGMENT, BREAKAGE/ EXPULSION: BREAKAGE'), DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS, MIGRATION') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A 38-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RESTLESS LEG SYNDROME, HEAVY PERIODS, NOCTURIA AND SMOKER. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPOTHYROIDISM, ASTHMA, HYPERTENSION, GERD, DIAPHRAGM, DYSMENORRHEA, CRAMP IN LOWER ABDOMEN, MYOMECTOMY, FLANK PAIN, GALLSTONES, KIDNEY STONE, LEFT LOWER QUADRANT PAIN, NAUSEA AND RADICULITIS LUMBOSACRAL. CONCOMITANT PRODUCTS INCLUDED CANNABIS SATIVA (MARIJUANA), ESOMEPRAZOLE SINCE 1997, ETHINYLESTRADIOL;ETYNODIOL DIACETATE (ZOVIA) SINCE 2006 TO (B)(6) 2012, FLUTICASONE PROPIONATE;SALMETEROL XINAFOATE (ADVAIR) SINCE 2007, LEVOTHYROXINE SINCE 1992, MELOXICAM SINCE (B)(6) 2017, MONTELUKAST SODIUM (SINGULAIR) SINCE 2007, SALBUTAMOL (ALBUTEROL) SINCE 2007 AND VERAPAMIL FROM (B)(6) 2012 TO DECEMBER 2013. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PHYSICAL PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION, PSYCH INJURY"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH BUPROPION, SERTRALINE AND SURGERY (DAVINCI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND UNDERWENT ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, MENORRHAGIA, VAGINAL HAEMORRHAGE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THIS RESULTED IN 3 COILS BEING SEEN AT THE OSTIUM. THE PROCEDURE WAS REPEATED ON THE PATIENT'S RIGHT SIDE. THIS TIME 4 COILS WERE SEEN WITHIN THE UTERINE CAVITY. CURRENT WEIGHT 236 LBS. DISCREPANCY NOTED IN INSERTION DATES-ESSURE INSERTION DATE- (B)(6) 2012, (B)(6) 2012 PATIENT RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN, DEVICE BREAKAGE, MIGRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.7 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. BOTH FALLOPIAN TUBES WERE BLOCKED SUCCESSFULLY.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN,DEVICE BREAKAGE LOT NUMBER: 952114 MANUFACTURE DATE: 2012-02 EXPIRATION DATE: 2015-02 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED NEW EVENT ADDED ABDOMINAL PAIN AND OUTCOME UPDATED PELVIC PAIN, ABDOMINAL PAIN. INCIDENT WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/FRACTURED ESSURE DEVICE FRAGMENT') AND MENORRHAGIA ('ABNORMAL BLEEDING (MENORRHAGIA)') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED RESTLESS LEG SYNDROME, HEAVY PERIODS, NOCTURIA AND SMOKER. CONCURRENT CONDITIONS INCLUDED MORBID OBESITY, HYPOTHYROIDISM, ASTHMA, HYPERTENSION, GERD, DIAPHRAGM, DYSMENORRHEA, LOWER ABDOMINAL PAIN, MYOMECTOMY, FLANK PAIN, GALLSTONES, KIDNEY STONE, LEFT LOWER QUADRANT PAIN, NAUSEA AND RADICULITIS LUMBOSACRAL. CONCOMITANT PRODUCTS INCLUDED CANNABIS SATIVA (MARIJUANA), ESOMEPRAZOLE SINCE 1997, ETHINYLESTRADIOL; ETHYNODIOL DIACETATE (ZOVIA) SINCE 2006 TO (B)(6) 2012, FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE (ADVAIR) SINCE 2007, LEVOTHYROXINE SINCE 1992, MELOXICAM SINCE (B)(6) 2017, MONTELUKAST SODIUM (SINGULAIR) SINCE 2007, SALBUTAMOL (ALBUTEROL) SINCE 2007 AND VERAPAMIL FROM (B)(6) 2012 TO (B)(6) 2013. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS"), PELVIC PAIN ("PHYSICAL PAIN/PELVIC AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY/MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). THE PATIENT WAS TREATED WITH BUPROPION, SERTRALINE AND SURGERY (DAVINCI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND UNDERWENT ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, MENORRHAGIA, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAILS: THIS RESULTED IN 3 COILS BEING SEEN AT THE OSTIUM. THE PROCEDURE WAS REPEATED ON THE PATIENT'S RIGHT SIDE. THIS TIME 4 COILS WERE SEEN WITHIN THE UTERINE CAVITY. CURRENT WEIGHT (B)(6) LBS. DISCREPANCY NOTED IN INSERTION DATES-ESSURE INSERTION DATE- (B)(6) 2012. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 42.7 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. ULTRASOUND SCAN VAGINA - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. BOTH FALLOPIAN TUBES WERE BLOCKED SUCCESSFULLY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WAS CONFIRMED IN PATIENT MEDICAL RECORDS: MENORRHAGIA, PELVIC PAIN,DEVICE BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2019: PFS AND MR WAS RECEIVED- NEW EVENTS: ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), ANXIETY, DEPRESSION, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERUS, DEVICE BREAKAGE¿, NEW REPORTER , PATIENT DEMOGRAPHIC, CONCOMITANT CONDITIONS , CONCOMITANT & TREATMENT DRUGS ,LAB DATA ,HISTORICAL CONDITIONS, LOT NUMBER WERE ADDED. OUTCOME OF EVENT ¿PHYSICAL PAIN/PELVIC AREA¿ UPDATED TO ¿RECOVERING / RESOLVING¿ INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCE'S DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671492 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952114 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other| R ADVAIR| ADVAIR| ADVAIR| ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| ALBUTEROL [SALBUTAMOL]| ESOMEPRAZOLE| ESOMEPRAZOLE| ESOMEPRAZOLE| LEVOTHYROXINE| LEVOTHYROXINE| LEVOTHYROXINE| MARIJUANA| MARIJUANA| MARIJUANA| MELOXICAM| MELOXICAM| MELOXICAM| SINGULAIR| SINGULAIR| SINGULAIR| VERAPAMIL| VERAPAMIL| VERAPAMIL| ZOVIA| ZOVIA| ZOVIA| ADVAIR| ALBUTEROL [SALBUTAMOL]| ESOMEPRAZOLE| LEVOTHYROXINE| MARIJUANA| MELOXICAM| SINGULAIR| VERAPAMIL| ZOVIA