MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Material Protrusion/Extrusion (2979); Migration (4003)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Pain (1994); Perforation (2001); Uterine Perforation (2121); Heavier Menses (2666); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 11/01/2007

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("crooked essure coil was poking through the serosa of the left fallopian tube") and genital haemorrhage ("abnormal bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and parity 3.On (b)(6) 2007, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain"), dyspareunia ("pain during intercourse"), alopecia ("hair loss") and procedural pain ("painful post-operative recovery").The patient was treated with surgery (a total laparoscopic hysterectomy to remove essure).Essure was removed on (b)(6) 2012.At the time of the report, the fallopian tube perforation, genital haemorrhage, dysmenorrhoea, dyspareunia, alopecia and procedural pain outcome was unknown.The reporter considered alopecia, dysmenorrhoea, dyspareunia, fallopian tube perforation, genital haemorrhage and procedural pain to be related to essure.The reporter commented: since having the surgery, plaintiff's symptoms are mostly resolved.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("crooked essure coil was poking through the serosa of the left fallopian tube"), embedded device ("essure coil possibly embedded in uterus.") and genital haemorrhage ("abnormal bleeding") in a 32-year-old female patient who had essure (batch no.624484) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "crooked device in the tube" on (b)(6) 2012.The patient's past medical history included multigravida and parity 3.Concurrent conditions included menses irregular with excessive bleeding, menometrorrhagia and cervicitis.On (b)(6) 2007, the patient had essure inserted.In 2007, the patient experienced dysmenorrhoea ("severe menstrual pain / dysmenorrhoea (cramping)"), dyspareunia ("pain during intercourse"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines"), headache ("headaches") and vaginal discharge ("vaginal discharge").In 2012, the patient experienced bacterial vaginosis ("bacterial vaginosis").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and abdominal pain, embedded device (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), procedural pain ("painful post-operative recovery"), device expulsion ("migration of device; uterus") and ovarian cyst ("reproductive system disorder or condition; ovarian cysts").The patient was treated with surgery (total hysterectomy (uterus and cervix removed) - with removal of essure devices) and surgery (total hysterectomy (uterus and cervix removed) - with removal of essure devices).Essure was removed on (b)(6) 2012.At the time of the report, the fallopian tube perforation, embedded device, genital haemorrhage, dysmenorrhoea, dyspareunia, alopecia and procedural pain outcome was unknown and the vaginal haemorrhage, menorrhagia, bacterial vaginosis, migraine, headache, device expulsion, ovarian cyst and vaginal discharge had resolved.The reporter considered alopecia, bacterial vaginosis, device expulsion, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, genital haemorrhage, headache, menorrhagia, migraine, ovarian cyst, procedural pain, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: since having the surgery, plaintiff's symptoms are mostly resolved.Right tube still not blocked completely.One to two trailing coils bilaterally after the placement of the essure devices.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.On (b)(6) 2008 patient underwent hysterosalpingogram resulted in tiny amount of contrast spills into the peritoneal cavity from the right fallopian tube, indicating incomplete closure.Concerning the injuries reported in this case, the following ones were described in patient¿s medical record confirming event: embedded device, dysmenorrhea, pelvic pain.Most recent follow-up information incorporated above includes: on 2-mar-2018: pfs+mr received, medically confirmed, reporter added, patient demographics added, lot number received, patient concomitant condition added, events added as: vaginal haemorrhage, menorrhagia, bacterial vaginosis, device physical property issue, migraine, headache, device expulsion, pelvic pain, vaginal discharge, abdominal pain, embedded device.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("crooked essure coil was poking through the serosa of the left fallopian tube / perforation (fallopian tube (s))"), embedded device ("essure coil possibly embedded in uterus./ failure to occlude (close) fallopian tube (s)"), the first episode of device expulsion ("migration of essure device location of device: uterus") and genital haemorrhage ("abnormal bleeding") in a 32-year-old female patient who had essure (batch no.624484) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "crooked device in the tube / malposition of essure device location of device: crooked device in the tube" on (b)(6) 2012.The patient's past medical history included multigravida and parity 3.Concurrent conditions included menses irregular with excessive bleeding, menometrorrhagia and cervicitis.In 2007, the patient experienced dysmenorrhoea ("severe menstrual pain / dysmenorrhoea (cramping)"), dyspareunia ("pain during intercourse"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2007, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and abdominal pain and embedded device (seriousness criteria medically significant and intervention required).On (b)(6) 2007, the patient had essure inserted.In (b)(6) 2007, the patient experienced vaginal discharge ("vaginal discharge / vaginal discharge").In (b)(6) 2012, the patient experienced the first episode of device expulsion (seriousness criteria medically significant and intervention required) and ovarian cyst ("reproductive system disorder or condition; ovarian cysts / reproductive system disorder or condition; ovarian cysts").In 2012, the patient experienced bacterial vaginosis ("bacterial vaginosis").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), procedural pain ("painful post-operative recovery") and the second episode of device expulsion ("migration of device; uterus").The patient was treated with surgery (total hysterectomy (uterus and cervix removed) - with removal of essure devices), surgery (total hysterectomy (uterus and cervix removed) - with removal of essure devices) and surgery (total hysterectomy (uterus and cervix removed) - with removal of essure devices).Essure was removed on (b)(6) 2012.At the time of the report, the fallopian tube perforation, embedded device, genital haemorrhage, dysmenorrhoea, dyspareunia, alopecia and procedural pain outcome was unknown and the vaginal haemorrhage, menorrhagia, bacterial vaginosis, migraine, headache, the last episode of device expulsion, ovarian cyst and vaginal discharge had resolved.The reporter considered alopecia, bacterial vaginosis, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, genital haemorrhage, headache, menorrhagia, migraine, ovarian cyst, procedural pain, vaginal discharge, vaginal haemorrhage, the first episode of device expulsion and the second episode of device expulsion to be related to essure.The reporter commented: since having the surgery, plaintiff's symptoms are mostly resolved.Right tube still not blocked completely.One to two trailing coils bilaterally after the placement of the essure devices diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.On (b)(6) 2008 patient underwent hysterosalpingogram resulted in tiny amount of contrast spills into the peritoneal cavity from the right fallopian tube, indicating incomplete closure.Concerning the injuries reported in this case, the following ones were described in patient¿s medical record confirming event: embedded device, dysmenorrhea, pelvic pain most recent follow-up information incorporated above includes: on 13-jun-2018: plaintiff fact sheet was received events added from pfs- migration of essure device location of device: uterus.Events onset date was updated.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("crooked essure coil was poking through the serosa of the left fallopian tube / perforation (fallopian tube (s))"), embedded device ("essure coil possibly embedded in uterus./ failure to occlude (close) fallopian tube (s)"), the first episode of device expulsion ("migration of essure device location of device: uterus") and genital haemorrhage ("abnormal bleeding") in a 32-year-old female patient who had essure (batch no.624484) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "crooked device in the tube / malposition of essure device location of device: crooked device in the tube" on (b)(6) 2012.The patient's past medical history included multigravida and parity 3.Concurrent conditions included menses irregular with excessive bleeding, menometrorrhagia and cervicitis.In 2007, the patient experienced dysmenorrhoea ("severe menstrual pain / dysmenorrhoea (cramping)"), dyspareunia ("pain during intercourse"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines") and headache ("headaches").In (b)(6) 2007, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with abdominal pain lower, pelvic pain and abdominal pain and embedded device (seriousness criteria medically significant and intervention required).On (b)(6) 2007, the patient had essure inserted.In (b)(6) 2007, the patient experienced vaginal discharge ("vaginal discharge / vaginal discharge").In (b)(6) 2012, the patient experienced the first episode of device expulsion (seriousness criteria medically significant and intervention required) and ovarian cyst ("reproductive system disorder or condition; ovarian cysts / reproductive system disorder or condition; ovarian cysts").In 2012, the patient experienced bacterial vaginosis ("bacterial vaginosis").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), alopecia ("hair loss"), procedural pain ("painful post-operative recovery") and the second episode of device expulsion ("migration of device; uterus").The patient was treated with surgery (total hysterectomy (uterus and cervix removed) - with removal of essure devices).Essure was removed on (b)(6) 2012.At the time of the report, the fallopian tube perforation, embedded device, genital haemorrhage, dysmenorrhoea, dyspareunia, alopecia and procedural pain outcome was unknown and the vaginal haemorrhage, menorrhagia, bacterial vaginosis, migraine, headache, the last episode of device expulsion, ovarian cyst and vaginal discharge had resolved.The reporter considered alopecia, bacterial vaginosis, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, genital haemorrhage, headache, menorrhagia, migraine, ovarian cyst, procedural pain, vaginal discharge, vaginal haemorrhage, the first episode of device expulsion and the second episode of device expulsion to be related to essure.The reporter commented: since having the surgery, plaintiff's symptoms are mostly resolved.Right tube still not blocked completely.One to two trailing coils bilaterally after the placement of the essure devices.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: total bilateral occlusion.On (b)(6) 2008 patient underwent hysterosalpingogram resulted in tiny amount of contrast spills into the peritoneal cavity from the right fallopian tube, indicating incomplete closure.Concerning the injuries reported in this case, the following ones were described in patient¿s medical record confirming event: embedded device, dysmenorrhea, pelvic pain quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jul-2018: quality safety evaluation of product technical complain.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7000817
• MDR Text Key: 91059894
• Report Number: 2951250-2017-06073
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2009
• Device Model Number: ESS305
• Device Lot Number: 624484
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR