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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Anemia (1706); Cyst(s) (1800); Dyspnea (1816); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Abdominal Cramps (2543); Ambulation Difficulties (2544); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('bleeding') in an adult female patient who had essure (batch no.628314) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in 2006, multigravida, parity 2, menses irregular, fatty liver and discharge.Concurrent conditions included ovarian cyst, menstruation prolonged, abdominal pain, abdominal cramps, shortness of breath, difficulty in walking, nausea, headache, uterus enlarged and uterine bleeding.Concomitant products included ibuprofen for abdominal pain as well as medroxyprogesterone.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), endometriosis ("endometriosis") and anaemia ("anemia requiring multiple blood transfusions and iv iron") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation).The dose of essure was increased.At the time of the report, the genital haemorrhage, pelvic pain, endometriosis, weight increased and anaemia outcome was unknown.The reporter considered anaemia, endometriosis, genital haemorrhage, pelvic pain and weight increased to be related to essure.The reporter commented: essure devices were placed in standard fashion into the bilateral tubal ostia with visible coils showing within the endometrial cavity as follows: right: 2 coils ; left: 2 coils.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin on (b)(6) 2017: 8.5 4/dl (abnormal).Magnetic resonance imaging on (b)(6) 2017: impression: 2.3 x 1.7 x 1.9 cm intramurai fibroid in the anterior left uterine body.5.3 x 4.3 x 3.7 cm large simple cyst in the right ovary.; on (b)(6) 2017: impression: patient has ovarian cyst.5 x 5 simple cyst.Pregnancy test on (b)(6) 2010: negative.Ultrasound pelvis on (b)(6) 2017: impression: probable small endometrial polyp.Probable uterine fibroids.There is a 2.2 cm left ovarian cyst.; on (b)(6) 2018: impression: heavy menstrual bleeding (menorrhagia); uterine fibroids, iron deficiency anemia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-dec-2019: pfs and mr received.Case becomes an incident.Lot number was added.Events added: pain, bleeding, weight gain, anemia requiring multiple blood transfusions and iv iron.Concomitant drugs, concomitant conditions, lab data and reporters 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of genital haemorrhage ('bleeding') in an adult female patient who had essure (batch no.628314) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in 2006, multigravida, parity 2, menses irregular, fatty liver and discharge.Concurrent conditions included ovarian cyst, menstruation prolonged, abdominal pain, abdominal cramps, shortness of breath, difficulty in walking, nausea, headache, uterus enlarged and uterine bleeding.Concomitant products included ibuprofen for abdominal pain as well as medroxyprogesterone.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), endometriosis ("endometriosis") and anaemia ("anemia requiring multiple blood transfusions and iv iron") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation).The dose of essure was increased.At the time of the report, the genital haemorrhage, pelvic pain, endometriosis, weight increased and anaemia outcome was unknown.The reporter considered anaemia, endometriosis, genital haemorrhage, pelvic pain and weight increased to be related to essure.The reporter commented: essure devices were placed in standard fashion into the bilateral tubal ostia with visible coils showing within the endometrial cavity as follows: right: 2 coils ; left: 2 coils.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6) 2017: 8.5 4/dl (abnormal).Magnetic resonance imaging - on (b)(6) 2017: impression: 1) 2.3 x 1.7 x 1.9 cm intramurai fibroid in the anterior left uterine body.2) 5.3 x 4.3 x 3.7 cm large simple cyst in the right ovary.; on (b)(6) 2017: impression: patient has ovarian cyst.5 x 5 simple cyst.Pregnancy test - on (b)(6) 2010: negative.Ultrasound pelvis - on (b)(6) 2017: impression: 1.Probable small endometrial polyp.2.Probable uterine fibroids.3.There is a 2.2 cm left ovarian cyst.; on (b)(6) 2018: impression: heavy menstrual bleeding (menorrhagia); uterine fibroids, iron deficiency anemia.Lot number:628314 manufacturing date: 2008/10 expiration date:2011/10.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 genital haemorrhage ('bleeding') in an adult female patient who had essure (batch no.628314) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in 2006, multigravida, parity 2, menses irregular, fatty liver and discharge.Concurrent conditions included ovarian cyst, menstruation prolonged, abdominal pain, abdominal cramps, shortness of breath, difficulty in walking, nausea, headache, uterus enlarged and uterine bleeding.Concomitant products included ibuprofen for abdominal pain as well as medroxyprogesterone.On (b)(6)2010, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic pain ("pain/stabbing pain"), endometriosis ("endometriosis"), anaemia ("anemia requiring multiple blood transfusions and iv iron"), vitamin d deficiency ("vitamin d deficiency"), pruritus ("itchy everywhere all day everyday") and menorrhagia ("horrible bleeding during period") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation, essure removed).The dose of essure was increased.At the time of the report, the genital haemorrhage, pelvic pain, endometriosis, weight increased, anaemia and vitamin d deficiency outcome was unknown.The reporter considered anaemia, endometriosis, genital haemorrhage, menorrhagia, pelvic pain, pruritus, vitamin d deficiency and weight increased to be related to essure.The reporter commented: essure devices were placed in standard fashion into the bilateral tubal ostia with visible coils showing within the endometrial cavity as follows: right: 2 coils ; left: 2 coils.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6)2017: 8.5 4/dl (abnormal).Magnetic resonance imaging - on (b)(6)2017: impression: 1) 2.3 x 1.7 x 1.9 cm intramurai fibroid in the anterior left uterine body.2) 5.3 x 4.3 x 3.7 cm large simple cyst in the right ovary.; on (b)(6)2017: impression: patient has ovarian cyst.5 x 5 simple cyst.Pregnancy test - on (b)(6)2010: negative.Ultrasound pelvis - on (b)(6)2017: impression: 1.Probable small endometrial polyp.2.Probable uterine fibroids.3.There is a 2.2 cm left ovarian cyst.; on (b)(6)2018: impression: heavy menstrual bleeding (menorrhagia); uterine fibroids, iron deficiency anemia.Lot number:628314 manufacturing date: 2008/10 expiration date:2011/10.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: information received via social media: new event - itchy everywhere all day everyday, horrible bleeding during period and reporter information were added.On 23-mar-2020: information received via social media: removal surgery added, new reporter added on 23-mar-2020: social media received.No new significant information was added.Reporter was added.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant 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 genital haemorrhage ('bleeding') in an adult female patient who had essure (batch no.628314) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in 2006, multigravida, parity 2, menses irregular, fatty liver and discharge.Concurrent conditions included ovarian cyst, menstruation prolonged, abdominal pain, abdominal cramps, shortness of breath, difficulty in walking, nausea, headache, uterus enlarged and uterine bleeding.Concomitant products included ibuprofen for abdominal pain as well as medroxyprogesterone.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), endometriosis ("endometriosis"), anaemia ("anemia requiring multiple blood transfusions and iv iron") and vitamin d deficiency ("vitamin d deficiency") and was found to have weight increased ("weight gain").The patient was treated with surgery (ablation).The dose of essure was increased.At the time of the report, the genital haemorrhage, pelvic pain, endometriosis, weight increased, anaemia and vitamin d deficiency outcome was unknown.The reporter considered anaemia, endometriosis, genital haemorrhage, pelvic pain, vitamin d deficiency and weight increased to be related to essure.The reporter commented: essure devices were placed in standard fashion into the bilateral tubal ostia with visible coils showing within the endometrial cavity as follows: right: 2 coils ; left: 2 coils.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6) -2017: 8.5 4/dl (abnormal).Magnetic resonance imaging - on (b)(6) 2017: impression: 1) 2.3 x 1.7 x 1.9 cm intramurai fibroid in the anterior left uterine body.2) 5.3 x 4.3 x 3.7 cm large simple cyst in the right ovary.; on (b)(6) 2017: impression: patient has ovarian cyst.5 x 5 simple cyst.Pregnancy test - on (b)(6) 2010: negative.Ultrasound pelvis - on (b)(6) 2017: impression: 1.Probable small endometrial polyp.2.Probable uterine fibroids.3.There is a 2.2 cm left ovarian cyst.; on (b)(6) 2018: impression: heavy menstrual bleeding (menorrhagia); uterine fibroids, iron deficiency anemia.Lot number:628314 manufacturing date: 2008/10 expiration date:2011/10 quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: social media received.New event vitamin d deficiency added a technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary 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: 9563721
• MDR Text Key: 185099276
• Report Number: 2951250-2020-00263
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2011
• Device Model Number: ESS305
• Device Lot Number: 628314
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 12/18/2019; 02/12/2020; 03/23/2020
• Supplement Dates FDA Received: 02/21/2020; 04/14/2020; 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; MEDROXYPROGESTERONE; MEDROXYPROGESTERONE; MEDROXYPROGESTERONE; MEDROXYPROGESTERONE
• Patient Outcome(s): Other; Required Intervention