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

BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923); Expulsion (2933); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Perforation (2001); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2011

Event Type Injury

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ("perforation of organs/migration of the implant") and device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2011, 91 days before insertion of essure, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").On (b)(6) 2011, the patient had essure inserted.The patient was treated with surgery (surgery to remove the essure implant) and surgery (surgery to remove the essure implant).Essure was removed on (b)(6) 2011.At the time of the report, the perforation, device breakage and pelvic pain outcome was unknown.The reporter considered device breakage, pelvic pain and perforation to be related to essure.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 ('perforation of organs/migration of the implant/failure to occlude (close) fallopian tube(s), perforation fallopian tube'), device breakage ('fracturing of the implant'), device dislocation ('migration of essure device location of device: outside of fallopian tube'), pregnancy with contraceptive device ('missed abortion which on the pathology showed partial molar pregnancy'), benign hydatidiform mole ('missed abortion which on the pathology showed partial molar pregnancy') and abortion missed ('missed abortion which on the pathology showed partial molar pregnancy') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included migraine, headache, miscarriage, arthritis, multigravida, parity 2 and intramural leiomyoma of uterus.Previously administered products included for birth control: oral contraceptive nos from 1994 to 2011; for heavy bleeding: loestrin; for an unreported indication: ibuprofen from 2011 to (b)(6) 2019 and orthocyclen.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2011 to november 2011 for birth control.In 2011, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced pelvic pain ("pain"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia"), migraine ("migraines / headaches") and headache ("migraines / headaches").On (b)(6) 2011, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion ("expulsion of essure device: hysterosalpingogram") and abortion missed (seriousness criterion medically significant), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have benign hydatidiform mole (seriousness criterion medically significant).The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2011.At the time of the report, the fallopian tube perforation, device dislocation, pelvic pain, vaginal haemorrhage, menorrhagia, migraine and headache had not resolved and the device breakage, device expulsion, pregnancy with contraceptive device, benign hydatidiform mole and abortion missed outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter provided no causality assessment for abortion missed, benign hydatidiform mole and pregnancy with contraceptive device with essure.The reporter considered device breakage, device dislocation, device expulsion, fallopian tube perforation, headache, menorrhagia, migraine, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure placement was performed on (b)(6) 2011, with easy placement on the patient's right fallopian tube and difficult placement on the left fallopian tube.An abdominal x-ray done shortly thereafter suggested a perforation on the left side with perhaps a normal tortuous tube on the right side.Diagnostic laparoscopy and hysteroscopy were performed several days later, but there was no evidence of perforation.The patient reported irregular bleeding since the time of her essure placement, but this seemed to be controlled with hormone replacement therapy in the form of a birth control pill.Removal detail: essure devices- removed in their entirety - pins were all present.Missed abortion which on the pathology showed partial molar pregnancy.Operative report revealed cylindrical, fimbriated and coiled segment of fallopian tube measuring 5.5 cm.In length by 0.7 cm.In maximum diameter.A pedunculated paratubal cyst measuring 0.7 cm.In diameter is present toward the fimbriated end.Sectioning reveals an unremarkable, pinpoint lumen.Additionally submitted in the specimen container are two metallic (one coiled and one straightened) components consistent with "essure device".Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on an unknown date: negative.Hysterosalpingogram - on (b)(6) 2011: essure device has been placed.The left-sided portion of the device is noted in a linear configuration probably within the left uterine tube.On the right side the radiopaque wire has a curved configuration possibly within a tortuous uterine tube versus within the cornu of the uterus.Cannot exclude ectopic location based on this single projection.¿concerning the injuries reported in this case, the following one was described in patients medical record : fallopian tube perforation, device dislocation." most recent follow-up information incorporated above includes: on (b)(6) 2019: medical record received.Events "missed abortion which on the pathology showed partial molar pregnancy, pregnancy with contraceptive device and device ineffective" were added.The case is medically confirmed.Reporter, historical condition and lab data was added.Incident no lot number or device sample was received in this case.We will conduct a review of our complaint records and other non-conformance's data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('perforation of organs/migration of the implant/failure to occlude (close) fallopian tube(s), perforation fallopian tube'), device breakage ('fracturing of the implant'), device dislocation ('migration of essure device location of device: outside of fallopian tube/coils were not in the right place'), pregnancy with contraceptive device ('missed abortion which on the pathology showed partial molar pregnancy'), abortion missed ('missed abortion which on the pathology showed partial molar pregnancy') and benign hydatidiform mole ('missed abortion which on the pathology showed partial molar pregnancy') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included migraine, headache, miscarriage, arthritis, multigravida, parity 2 and intramural leiomyoma of uterus.Previously administered products included for birth control: oral contraceptive nos from 1994 to 2011; for heavy bleeding: loestrin; for an unreported indication: ibuprofen from 2011 to (b)(6) 2020 and orthocyclen.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2011 to (b)(6) 2011 for birth control as well as ibuprofen from (b)(6) 2011 to (b)(6) 2011.On (b)(6) 2011, the patient had essure inserted.In 2011, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2011, the patient experienced pelvic pain ("pain"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia"), migraine ("migraines / headaches") and headache ("migraines / headaches").On (b)(6) 2011, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant), experienced abortion missed (seriousness criterion medically significant), device expulsion ("expulsion of essure device: hysterosalpingogram"), abdominal pain ("my belly is killing me") and neck pain ("i have extreme neck issues") and was found to have benign hydatidiform mole (seriousness criterion medically significant).The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2011.At the time of the report, the fallopian tube perforation, device dislocation, pelvic pain, vaginal haemorrhage, menorrhagia, migraine and headache had not resolved and the device breakage, pregnancy with contraceptive device, abortion missed, benign hydatidiform mole, device expulsion, abdominal pain and neck pain outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter provided no causality assessment for abortion missed, benign hydatidiform mole and pregnancy with contraceptive device with essure.The reporter considered abdominal pain, device breakage, device dislocation, device expulsion, fallopian tube perforation, headache, menorrhagia, migraine, neck pain, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure placement was performed on (b)(6) 2011, with easy placement on the patient's right fallopian tube and difficult placement on the left fallopian tube.An abdominal x-ray done shortly thereafter suggested a perforation on the left side with perhaps a normal tortuous tube on the right side.Diagnostic laparoscopy and hysteroscopy were performed several days later, but there was no evidence of perforation.The patient reported irregular bleeding since the time of her essure placement, but this seemed to be controlled with hormone replacement therapy in the form of a birth control pill.Removal detail: essure devices- removed in their entirety - pins were all present.Missed abortion which on the pathology showed partial molar pregnancy.Operative report revealed cylindrical, fimbriated and coiled segment of fallopian tube measuring 5.5 cm.In length by 0.7 cm.In maximum diameter.A pedunculated paratubal cyst measuring 0.7 cm.In diameter is present toward the fimbriated end.Sectioning reveals an unremarkable, pinpoint lumen.Additionally submitted in the specimen container are two metallic (one coiled and one straightened) components consistent with "essure device".Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on an unknown date: negative.Hysterosalpingogram - on (b)(6) 2011: essure device has been placed.The left-sided portion of the device is noted in a linear configuration probably within the left uterine tube.On the right side the radiopaque wire has a curved configuration possibly within a tortuous uterine tube versus within the cornu of the uterus.Cannot exclude ectopic location based on this single projection; on (b)(6) 2011: total bilateral occlusion; on (b)(6) 2011: malposition of essure device, perforation (fallopian tube), expulsion of essure device.The coils were not in the right place and some of the coils were missing.¿concerning the injuries reported in this case, the following one was described in patients medical record : fallopian tube perforation, device dislocation." quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('perforation of organs/migration of the implant/failure to occlude (close) fallopian tube(s), perforation fallopian tube'), device breakage ('fracturing of the implant'), device dislocation ('migration of essure device location of device: outside of fallopian tube/coils were not in the right place'), pregnancy with contraceptive device ('missed abortion which on the pathology showed partial molar pregnancy'), benign hydatidiform mole ('missed abortion which on the pathology showed partial molar pregnancy') and abortion missed ('missed abortion which on the pathology showed partial molar pregnancy') in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included migraine, headache, miscarriage, arthritis, multigravida, parity 2 and intramural leiomyoma of uterus.Previously administered products included for birth control: oral contraceptive nos from 1994 to 2011; for heavy bleeding: loestrin; for an unreported indication: ibuprofen from 2011 to (b)(6) 2020 and orthocyclen.Concomitant products included medroxyprogesterone acetate (depo provera) from (b)(6) 2011 for birth control as well as ibuprofen from (b)(6) 2011.On (b)(6) 2011, the patient had essure inserted.In 2011, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2011, the patient experienced pelvic pain ("pain"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia"), migraine ("migraines / headaches") and headache ("migraines / headaches").On (b)(6) 2011, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion ("expulsion of essure device: hysterosalpingogram"), abortion missed (seriousness criterion medically significant), abdominal pain ("my belly is killing me") and neck pain ("i have extreme neck issues"), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and was found to have benign hydatidiform mole (seriousness criterion medically significant).The patient was treated with surgery (bilateral salpingectomy).Essure was removed on (b)(6) 2011.At the time of the report, the fallopian tube perforation, device dislocation, pelvic pain, vaginal haemorrhage, menorrhagia, migraine and headache had not resolved and the device breakage, device expulsion, pregnancy with contraceptive device, benign hydatidiform mole, abortion missed, abdominal pain and neck pain outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter provided no causality assessment for abortion missed, benign hydatidiform mole and pregnancy with contraceptive device with essure.The reporter considered abdominal pain, device breakage, device dislocation, device expulsion, fallopian tube perforation, headache, menorrhagia, migraine, neck pain, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure placement was performed on (b)(6) 2011, with easy placement on the patient's right fallopian tube and difficult placement on the left fallopian tube.An abdominal x-ray done shortly thereafter suggested a perforation on the left side with perhaps a normal tortuous tube on the right side.Diagnostic laparoscopy and hysteroscopy were performed several days later, but there was no evidence of perforation.The patient reported irregular bleeding since the time of her essure placement, but this seemed to be controlled with hormone replacement therapy in the form of a birth control pill.Removal detail: essure devices- removed in their entirety - pins were all present.Missed abortion which on the pathology showed partial molar pregnancy.Operative report revealed cylindrical, fimbriated and coiled segment of fallopian tube measuring 5.5 cm.In length by 0.7 cm.In maximum diameter.A pedunculated paratubal cyst measuring 0.7 cm.In diameter is present toward the fimbriated end.Sectioning reveals an unremarkable, pinpoint lumen.Additionally submitted in the specimen container are two metallic (one coiled and one straightened) components consistent with "essure device".Diagnostic results (normal ranges are provided in parenthesis if available): human chorionic gonadotropin - on an unknown date: negative.Hysterosalpingogram - on (b)(6) 2011: essure device has been placed.The left-sided portion of the device is noted in a linear configuration probably within the left uterine tube.On the right side the radiopaque wire has a curved configuration possibly within a tortuous uterine tube versus within the cornu of the uterus.Cannot exclude ectopic location based on this single projection; on (b)(6) 2011: total bilateral occlusion; on (b)(6) 2011: malposition of essure device, perforation (fallopian tube), expulsion of essure device.The coils were not in the right place and some of the coils were missing.¿concerning the injuries reported in this case, the following one was described in patients medical record : fallopian tube perforation, device dislocation." most recent follow-up information incorporated above includes: on 13-apr-2020: social media received: new event my belly is killing me , i have extreme neck issues were added.Concomitant drug were added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

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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

7056540

MDR Text Key

92911437

Report Number

2951250-2017-08267

Device Sequence Number

Product Code

HHS

Combination Product (y/n)

PMA/PMN Number

P020014

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,health professional

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

05/07/2020

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?

Yes

Device Operator

Health Professional

Device Model Number

ESS305

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Initial Date Manufacturer Received

11/01/2017

Initial Date FDA Received

11/23/2017

Supplement Dates Manufacturer Received

06/25/2019
06/26/2019
04/13/2020
05/07/2020

Supplement Dates FDA Received

07/03/2019
07/08/2019
05/04/2020
05/07/2020

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Treatment

DEPO PROVERA; DEPO PROVERA; DEPO PROVERA; DEPO PROVERA; IBUPROFEN; IBUPROFEN

Patient Outcome(s)

Other; Required Intervention;

Patient Age

39 YR

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

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