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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Weight Changes (2607); Foreign Body In Patient (2687)

Event Date 07/16/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: unavailable to see right essure"), pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("auto-immune disease") in a (b)(6) female patient who had essure (batch no.901335) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "no confirmation test".The patient's past medical history included c-section and multiparous.Concurrent conditions included morbid obesity, breast cancer, hernia, contralateral prophylactic mastectomy, breast lump and tubal ligation.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criterion medically significant) and genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2013, 1 year 5 months after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), weight increased ("weight gain"), migraine ("migraines"), fatigue ("fatigue"), abdominal distension ("bloating"), alopecia ("hair loss"), back pain ("back pain") and menstrual disorder ("menstruation issues").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, genital haemorrhage, autoimmune disorder, weight increased, migraine, fatigue, abdominal distension, alopecia, back pain and menstrual disorder outcome was unknown.The reporter considered abdominal distension, alopecia, autoimmune disorder, back pain, device dislocation, fatigue, genital haemorrhage, menstrual disorder, migraine, pelvic pain and weight increased to be related to essure.The reporter commented: 13 coils visualized on left and 3 coils visualized on right.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6).On (b)(6) 2013, ultrasound pelvis showed essure at left cornu unable to identify essure on right side.Most recent follow-up information incorporated above includes: on 2-mar-2018: pfs and mr received: case became incident.New reporters, patient demographic information, product indication updated, lot no, concomitant disease, historical condition, new events device dislocation, genital haemorrhage and device monitoring procedure not performed added.On 2-mar-2018: mr received: new reporters and lab data added.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 device dislocation ("migration of essure device location of device: unavailable to see right essure"), pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("auto-immune disease") in a 31-year-old female patient who had essure (batch no.901335) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiple caesarean sections and multiparous.Concurrent conditions included morbid obesity, breast cancer, hernia, contralateral prophylactic mastectomy, breast lump and tubal ligation.In (b)(6) 20, the patient experienced genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2013, 1 year 5 months after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), weight increased ("weight gain"), migraine ("migraines"), fatigue ("fatigue"), abdominal distension ("bloating"), alopecia ("hair loss"), back pain ("back pain") and menstrual disorder ("menstruation issues").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, genital haemorrhage, autoimmune disorder, weight increased, migraine, fatigue, abdominal distension, alopecia, back pain, menstrual disorder and device expulsion outcome was unknown.The reporter considered abdominal distension, alopecia, autoimmune disorder, back pain, device dislocation, device expulsion, fatigue, genital haemorrhage, menstrual disorder, migraine, pelvic pain and weight increased to be related to essure.The reporter commented: 13 coils visualized on left and 3 coils visualized on right.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 40.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: total bilateral occlusion on (b)(6) 2013, ultrasound pelvis showed essure at left cornu unable to identify essure on right side.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-aug-2018: quality-safety evaluation of product technical problem update.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 device dislocation ("migration of essure device location of device: unavailable to see right essure"), pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("auto-immune disease") in a 31-year-old female patient who had essure (batch no.901335) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiple caesarean sections and multiparous.Concurrent conditions included morbid obesity, breast cancer, hernia, contralateral prophylactic mastectomy, breast lump and tubal ligation.In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant).On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2013, 1 year 5 months after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), weight increased ("weight gain"), migraine ("migraines"), fatigue ("fatigue"), abdominal distension ("bloating"), alopecia ("hair loss"), back pain ("back pain") and menstrual disorder ("menstruation issues").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, genital haemorrhage, autoimmune disorder, weight increased, migraine, fatigue, abdominal distension, alopecia, back pain, menstrual disorder and device expulsion outcome was unknown.The reporter considered abdominal distension, alopecia, autoimmune disorder, back pain, device dislocation, device expulsion, fatigue, genital haemorrhage, menstrual disorder, migraine, pelvic pain and weight increased to be related to essure.The reporter commented: 13 coils visualized on left and 3 coils visualized on right.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 40.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: total bilateral occlusion.On (b)(6) 2013, ultrasound pelvis showed essure at left cornu unable to identify essure on right side.Most recent follow-up information incorporated above includes: on 3-jul-2018: previously reported event "no confirmation test" deleted.Event "expulsion of essure device" added from pfs.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 device dislocation ("migration of essure device location of device: unavailable to see right essure / left essure on cornu, right essure not in place."), pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("auto-immune disease") in a 31-year-old female patient who had essure (batch no.901335) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multiple caesarean sections, multiparous, asthma, uti and stroke.* on (b)(6) 2013, ultrasound pelvis showed essure at left cornu unable to identify essure on right side.Previously administered products included for an unreported indication: nuvaring from (b)(6) 2010 to (b)(6) 2012 and mirena from 2009 to (b)(6) 2010.Concurrent conditions included morbid obesity, breast cancer, hernia, contralateral prophylactic mastectomy, breast lump and tubal ligation.Concomitant products included acetylsalicylic acid; dipyridamole (aggrenox) since (b)(6) 2012 to 2013, fluconazole (diflucan) since (b)(6) 2017, gabapentin from (b)(6) 2013 to (b)(6) 2014, loratadine from (b)(6) 2011 to (b)(6) 2013, paracetamol (acetaminophen), rivaroxaban (xarelto) since 2016, salbutamol (albuterol) from (b)(6) 2012 to (b)(6) 2013, warfarin sodium (coumadin) from 2013 to 2015 and warfarin from 2013 to 2015.In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant), anxiety ("anxiety / mental anguish"), depression ("depression"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and female sexual dysfunction ("apareunia (inability to have sexual intercourse)").On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), 1 year 5 months after insertion of essure.On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), migraine ("migraines"), fatigue ("fatigue"), abdominal distension ("bloating"), alopecia ("hair loss"), back pain ("back pain") and menstrual disorder ("menstruation issues") and was found to have weight increased ("weight gain").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, genital haemorrhage, autoimmune disorder, weight increased, migraine, fatigue, abdominal distension, alopecia, back pain, menstrual disorder, device expulsion, anxiety, depression, vaginal haemorrhage, menorrhagia and female sexual dysfunction outcome was unknown.The reporter considered abdominal distension, alopecia, anxiety, autoimmune disorder, back pain, depression, device dislocation, device expulsion, fatigue, female sexual dysfunction, genital haemorrhage, menorrhagia, menstrual disorder, migraine, pelvic pain, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: 13 coils visualized on left and 3 coils visualized on right.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 40.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-jan-2019: concomitant drugs were added.Added events abnormal bleeding (vaginal, menorrhagia), apareunia (inability to have sexual intercourse).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-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: unavailable to see right essure / left essure on cornu, right essure not in place."), pelvic pain ("pelvic pain"), genital haemorrhage ("abnormal bleeding (general)") and autoimmune disorder ("auto-immune disease") in a 31-year-old female patient who had essure (batch no.901335) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multiple caesarean sections and multiparous.Concurrent conditions included morbid obesity, breast cancer, hernia, contralateral prophylactic mastectomy, breast lump and tubal ligation.Concomitant products included paracetamol (acetaminophen).In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criterion medically significant), anxiety ("anxiety / mental anguish") and depression ("depression").On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced pelvic pain (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced device expulsion ("expulsion of essure device").On (b)(6) 2013, 1 year 5 months after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), weight increased ("weight gain"), migraine ("migraines"), fatigue ("fatigue"), abdominal distension ("bloating"), alopecia ("hair loss"), back pain ("back pain") and menstrual disorder ("menstruation issues").Essure treatment was not changed.At the time of the report, the device dislocation, pelvic pain, genital haemorrhage, autoimmune disorder, weight increased, migraine, fatigue, abdominal distension, alopecia, back pain, menstrual disorder, device expulsion, anxiety and depression outcome was unknown.The reporter considered abdominal distension, alopecia, anxiety, autoimmune disorder, back pain, depression, device dislocation, device expulsion, fatigue, genital haemorrhage, menstrual disorder, migraine, pelvic pain and weight increased to be related to essure.The reporter commented: 13 coils visualized on left and 3 coils visualized on right.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 40.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2012: total bilateral occlusion on (b)(6) 2013, ultrasound pelvis showed essure at left cornu unable to identify essure on right side.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received.Events anxiety / mental anguish and depression added.Concomitant drug acetaminophen added.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: 7502213
• MDR Text Key: 107869573
• Report Number: 2951250-2018-02129
• 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: health professional,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: ESS305
• Device Lot Number: 901335
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 08/01/2018; 10/05/2018; 01/07/2019
• Supplement Dates FDA Received: 07/25/2018; 08/08/2018; 10/12/2018; 01/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACETAMINOPHEN; AGGRENOX; ALBUTEROL [SALBUTAMOL]; COUMADIN; DIFLUCAN; GABAPENTIN; LORATADINE; WARFARIN; XARELTO
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 64