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)

Event Date 12/07/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ('abdominal pain') in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gravida ii, parity 3, menorrhagia, uterine fibroid, unspecified essential hypertension, syncope, morbid obesity and chlamydial infection.Concomitant products included diazepam (valium), ketorolac tromethamine (toradol) and oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2017, the patient experienced genital haemorrhage ("abnormal bleeding") and iron deficiency anaemia ("anemia/low iron"), 7 years 10 months after insertion of essure.On (b)(6) 2017, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced migraine ("migraine/ headache") and headache ("migraine/headache").The patient was treated with ferrous sulfate, medroxyprogesterone acetate (depo provera), paracetamol (tylenol) and surgery (total abdominal hysterectomy and bilateral).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain, genital haemorrhage, iron deficiency anaemia, migraine and headache outcome was unknown.The reporter considered abdominal pain, genital haemorrhage, headache, iron deficiency anaemia and migraine to be related to essure.The reporter commented: discrepancy noted in essure insertion date ((b)(6) 2010 and (b)(6) 2008).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-mar-2020: information received via plaintiff fact sheet.Event injury to herself was updated.New events added: abnormal bleeding, anemia, migraine and headache and abdominal pain.Case category updated to serious incident.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 abdominal pain ('abdominal pain') and iron deficiency anaemia ('anemia/low iron') in a 38-year-old female patient who had essure (batch no.758629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3, menorrhagia, uterine fibroid, unspecified essential hypertension, syncope, morbid obesity and chlamydial infection.Concomitant products included diazepam (valium), ketorolac tromethamine (toradol) and oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2017, the patient experienced iron deficiency anaemia (seriousness criterion medically significant) and genital haemorrhage ("abnormal bleeding"), 7 years 10 months after insertion of essure.On (b)(6) 2017, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("pelvic pain"), abdominal pain lower ("lower abdominal pain"), dysmenorrhoea ("pain frequent specially during my cycle"), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia"), pelvic discomfort ("pelvic and hip pressure"), migraine ("migraine/ headache"), headache ("migraine /headache") and arthralgia ("pelvic and hip pressure") and was found to have uterine leiomyoma ("uterine fibroid").The patient was treated with ferrous sulfate, medroxyprogesterone acetate (depo provera), paracetamol (tylenol), surgery (total abdominal hysterectomy and bilateral) and blood transfusion.Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain, iron deficiency anaemia, pelvic pain, abdominal pain lower, vaginal haemorrhage, menorrhagia and migraine had resolved and the dysmenorrhoea, genital haemorrhage, pelvic discomfort, headache, uterine leiomyoma and arthralgia outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, arthralgia, dysmenorrhoea, genital haemorrhage, headache, iron deficiency anaemia, menorrhagia, migraine, pelvic discomfort, pelvic pain, uterine leiomyoma and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in essure insertion date ((b)(6) 2010 and (b)(6) 2008) diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: total bilateral occlusion.Lot number: 758629 manufacturing date: 2010-07 expiration date: 2013-07.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-oct-2020: quality-safety evaluation of product technical complaint.We received a lot number in this case.A technical investigation was 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 abdominal pain ('abdominal pain') and iron deficiency anaemia ('anemia/low iron') in a 38-year-old female patient who had essure (batch no.758629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3, menorrhagia, uterine fibroid, unspecified essential hypertension, syncope, morbid obesity and chlamydial infection.Concomitant products included diazepam (valium), ketorolac tromethamine (toradol) and oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2010, the patient had essure inserted.On (b)(6) 2017, the patient experienced iron deficiency anaemia (seriousness criterion medically significant) and genital haemorrhage ("abnormal bleeding"), 7 years 10 months after insertion of essure.On (b)(6) 2017, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("pelvic pain"), abdominal pain lower ("lower abdominal pain"), dysmenorrhoea ("pain frequent specially during my cycle"), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia"), pelvic discomfort ("pelvic and hip pressure"), migraine ("migraine/ headache"), headache ("migraine /headache") and arthralgia ("pelvic and hip pressure") and was found to have uterine leiomyoma ("uterine fibroid").The patient was treated with ferrous sulfate, medroxyprogesterone acetate (depo provera), paracetamol (tylenol), surgery (total abdominal hysterectomy and bilateral) and blood transfusion.Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain, iron deficiency anaemia, pelvic pain, abdominal pain lower, vaginal haemorrhage, menorrhagia and migraine had resolved and the dysmenorrhoea, genital haemorrhage, pelvic discomfort, headache, uterine leiomyoma and arthralgia outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, arthralgia, dysmenorrhoea, genital haemorrhage, headache, iron deficiency anaemia, menorrhagia, migraine, pelvic discomfort, pelvic pain, uterine leiomyoma and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in essure insertion date ((b)(6) 2010 and (b)(6) 2008).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: total bilateral occlusion.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pfs received- new events vaginal bleeding, menorrhagia, uterine fibroid, pain frequent specially during my cycle, pelvic pain, lower abdominal pain, pelvic and hip pressure were added.Lot number was added.Event outcome of abnormal bleeding, abdominal pain, anemia, migraines were updated.Lab data was updated.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 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 abdominal pain ('abdominal pain') and iron deficiency anaemia ('blood or heart disorder/condition type: anemia/low iron') in a 38-year-old female patient who had essure (batch no.758629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, parity 3, menorrhagia, uterine fibroid, unspecified essential hypertension, syncope, morbid obesity and chlamydial infection.Concomitant products included diazepam (valium), ketorolac tromethamine (toradol) and oxycodone hydrochloride;paracetamol (percocet).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced dysmenorrhoea ("pain frequent specially during my cycle").On (b)(6) 2017, the patient experienced iron deficiency anaemia (seriousness criterion medically significant) and genital haemorrhage ("abnormal bleeding"), 6 years 10 months after insertion of essure.On (b)(6) 2017, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("pelvic pain"), abdominal pain lower ("lower abdominal pain"), vaginal haemorrhage ("vaginal bleeding"), heavy menstrual bleeding ("menorrhagia"), pelvic discomfort ("pelvic and hip pressure"), migraine ("migraine/ headache"), headache ("migraine /headache") and arthralgia ("pelvic and hip pressure") and was found to have uterine leiomyoma ("reproductive system disorder or condition - type of disorder or condition : uterine fibroid").The patient was treated with ferrous sulfate, medroxyprogesterone acetate (depo provera), paracetamol (tylenol), surgery (total abdominal hysterectomy and bilateral) and blood transfusion.Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain, iron deficiency anaemia, pelvic pain, abdominal pain lower, vaginal haemorrhage, heavy menstrual bleeding and migraine had resolved and the dysmenorrhoea, genital haemorrhage, pelvic discomfort, headache, uterine leiomyoma and arthralgia outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, arthralgia, dysmenorrhoea, genital haemorrhage, headache, heavy menstrual bleeding, iron deficiency anaemia, migraine, pelvic discomfort, pelvic pain, uterine leiomyoma and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in essure insertion date (b)(6) 2010 and (b)(6)2010 and (b)(6) 2008, (b)(6) 2011.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: total bilateral occlusion.Lot number: 758629 manufacturing date: 2010-07 expiration date: 2013-07.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 28-apr-2021: no new information were added.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 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: 10009819
• MDR Text Key: 191432784
• Report Number: 2951250-2020-06093
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2013
• Device Model Number: ESS305
• Device Lot Number: 758629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]; TORADOL; TORADOL; TORADOL; TORADOL; VALIUM; VALIUM; VALIUM; VALIUM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR