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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abortion (1688); Anemia (1706); Diarrhea (1811); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Nausea (1970); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Reaction (2414); No Code Available (3191); Pregnancy (3193)

Event Date 12/01/2010

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain'), pregnancy with contraceptive device ('pregnancy (with complications)'), abortion spontaneous ('pregnancy (termination)'), caesarean section ('cesarean section') and crohn's disease ('gastrointestinal or digestive system condition type: crohn's disease') in a female patient who had essure (batch no.787215, 686081) 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" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included gravida ii and parity 6 ((b)(6) 1995, (b)(6) 1998, (b)(6) 2003, (b)(6) 2008, (b)(6) 2010, (b)(6) 2018).Concurrent conditions included abdominal pain, diarrhea, inflammatory bowel disease, urinary tract infection, iron deficiency anemia, internal hemorrhoids and cholelithiasis.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), rash ("allergic or hypersensitivity reaction type: rashes"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced gastrointestinal infection ("infection (other) describe: gastrointestinal"), migraine ("migraine/headaches"), nausea ("nausea"), abortion spontaneous (seriousness criterion medically significant), crohn's disease (seriousness criterion medically significant) and vulvovaginal pain ("vaginal pain "), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and underwent caesarean section (seriousness criterion medically significant).The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, vaginal haemorrhage, rash, dysmenorrhoea, gastrointestinal infection, migraine, nausea, dyspareunia, fatigue, crohn's disease, vaginal discharge and vulvovaginal pain had not resolved and the pregnancy with contraceptive device, abortion spontaneous and caesarean section outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 9, para 6.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abortion spontaneous, caesarean section, crohn's disease, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal infection, genital haemorrhage, menorrhagia, migraine, nausea, pelvic pain, pregnancy with contraceptive device, rash, vaginal discharge, vaginal haemorrhage and vulvovaginal pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on an unknown date: positive pregnancy test.Most recent follow-up information incorporated above includes: on 24-jan-2020: plaintiff fact sheet and medical record was received.Medically confirmed case.Lot number were added.Event added from pfs- pain, abnormal bleeding (general), abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), rashes, dysmenorrhea (cramping), gastrointestinal infection, migraine headaches, nausea, pregnancy (with complications), pregnancy (termination), device ineffective, cesarean section, dyspareunia (painful sexual intercourse), fatigue, crohn's disease, vaginal discharge, vaginal pain, she did not undergo essure confirmation test.Reporter information, medical history, events onset date, essure removal date were added.Device category changed from other event to 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 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 pelvic pain ('pain'), pregnancy with contraceptive device ('pregnancy (with complications)'), abortion spontaneous ('pregnancy (termination)') and caesarean section ('cesarean section') in a female patient who had essure (batch no.686081, 787215) 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" and device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's medical history included multigravida and parity 6 ((b)(6) 1995, (b)(6) 1998, (b)(6) 2003, (b)(6) 2008, (b)(6) 2010, (b)(6) 2018).Concurrent conditions included abdominal pain, diarrhea, inflammatory bowel disease, urinary tract infection, iron deficiency anemia, internal hemorrhoids, cholelithiasis and caesarean section.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dermatitis allergic ("allergic or hypersensitivity reaction type: rashes"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue") and vaginal discharge ("vaginal discharge").On an unknown date, the patient experienced gastrointestinal infection ("infection (other) describe: gastrointestinal"), migraine ("migraine/headaches"), nausea ("nausea"), abortion spontaneous (seriousness criterion medically significant), crohn's disease ("gastrointestinal or digestive system condition type: crohn's disease") and vulvovaginal pain ("vaginal pain "), was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and underwent caesarean section (seriousness criterion medically significant).The patient was treated with surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, vaginal haemorrhage, dermatitis allergic, dysmenorrhoea, gastrointestinal infection, migraine, nausea, dyspareunia, fatigue, crohn's disease, vaginal discharge and vulvovaginal pain had not resolved and the pregnancy with contraceptive device, abortion spontaneous and caesarean section outcome was unknown.Pregnancy related information: retrospective report.The patient's obstetric status was gravida 9, para 6.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first, second and third trimesters.The pregnancy outcome was reported as a live birth of a child with health problems.The reporter considered abortion spontaneous, caesarean section, crohn's disease, dermatitis allergic, dysmenorrhoea, dyspareunia, fatigue, gastrointestinal infection, genital haemorrhage, menorrhagia, migraine, nausea, pelvic pain, pregnancy with contraceptive device, vaginal discharge, vaginal haemorrhage and vulvovaginal pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on an unknown date: positive pregnancy test.Lot number: 686081 manufacture date: 2009-11 expiration date: 2012-11.Lot number: 787215 manufacture date: 2010-09 expiration date: 2013-09.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-mar-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation will 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.

• 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: 9720988
• MDR Text Key: 190104744
• Report Number: 2951250-2020-01492
• 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
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2012
• Device Model Number: ESS305
• Device Lot Number: 686081, 787215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR