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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Anemia (1706); Genital Bleeding (4507)

Event Date 08/01/2011

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('lower abdominal pain'), genital haemorrhage ('general abnormal bleeding/ heavy bleeding') and iron deficiency anaemia ('anemia/iron deficiency') in a (b)(6) 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 monitoring procedure not performed "plaintiff did not under went an essure conformation test".The patient's concurrent conditions included obesity.Concomitant products included iron since (b)(6) 2011 and medroxyprogesterone acetate (depo provera) from (b)(6) 2011 to (b)(6) 2011.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced iron deficiency anaemia (seriousness criterion medically significant).In (b)(6) 2011, the patient experienced migraine ("migraine").In (b)(6) 2014, the patient experienced mitral valve prolapse ("blood/heart disorder/ blood or heart disorder/condition type: mitral valve prolapse").On (b)(6) 2014, the patient experienced bladder disorder ("bladder/urinary problems : bladder problems") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain"), 3 years 1 month after insertion of essure.In (b)(6) 2014, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping").In (b)(6) 2018, the patient experienced menorrhagia ("menorrhagia (heavy menstrual bleeding").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria hospitalization and medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), cystitis ("infection (bladder urinary tract/vaginal) type: bladder"), urinary tract infection ("infection (bladder urinary tract/vaginal) type: uti"), vaginal infection ("infection (bladder urinary tract/vaginal) type: vaginal"), headache ("headaches"), back pain ("lower back pain"), chest pain ("chest pain"), vulvovaginal pain ("vaginal pain"), urinary tract disorder ("urinary problems or changes"), iron deficiency ("iron deficiency") and oropharyngeal pain ("sore throat").The patient was treated with ibuprofen, surgery (to remove essure) and blood transfusion.Essure was removed.At the time of the report, the abdominal pain lower, genital haemorrhage, dysmenorrhoea, mitral valve prolapse, iron deficiency anaemia, menorrhagia, bladder disorder, vaginal discharge, migraine, weight increased, vaginal haemorrhage, cystitis, urinary tract infection, vaginal infection, headache, back pain, chest pain, vulvovaginal pain, urinary tract disorder, iron deficiency and oropharyngeal pain outcome was unknown.The reporter considered abdominal pain lower, back pain, bladder disorder, chest pain, cystitis, dysmenorrhoea, genital haemorrhage, headache, iron deficiency, iron deficiency anaemia, menorrhagia, migraine, mitral valve prolapse, oropharyngeal pain, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 41.6 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-sep-2019: f/u 2, f/u 3 and f/ u 4 processed together.New pfs received- event ¿ injury¿ replaced with new events pain: dysmenorrhea (cramping), bleeding: general.Abnormal bleeding, blood/heart disorder, anemia ,menorrhagia (heavy menstrual bleeding), bladder/urinary problems: bladder problems., vaginal discharge, other injuries/symptoms : migraine, weight gain, plaintiff did not undergo essure confirmation test.Product indication was updated.On 19-sep-2019: f/u 2, f/u 3 and f/ u 4 processed together.New pfs received- new events added: abnormal bleeding (vaginal),infection (bladder/urinary tract/vaginal); headaches; blood or heart disorder/condition type: mitral valve prolapse, lower back pan, lower abdominal pain, chest pain, vaginal pain, blood loss, urinary problems or changes.Event blood or heart disorder/condition type was updated to blood or heart disorder/condition type: mitral valve prolapse.Reporters information was added.Concomitant drugs were added.On 20-sep-2019: f/u 2, f/u 3 and f/ u 4 processed together.New pfs received- concomitant conditions and treatment drug were added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 lower ('lower abdominal pain'), genital haemorrhage ('general abnormal bleeding/ heavy bleeding') and iron deficiency anaemia ('anemia/iron deficiency') in a 31-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 monitoring procedure not performed "plaintiff did not underwent an essure confirmation test".The patient's concurrent conditions included obesity.Concomitant products included iron since (b)(6) 2011 and medroxyprogesterone acetate (depo provera) from (b)(6) 2011 to (b)(6) 2011.On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2011, the patient experienced iron deficiency anaemia (seriousness criterion medically significant).In (b)(6) 2011, the patient experienced migraine ("migraine").In (b)(6) 2014, the patient experienced mitral valve prolapse ("blood/heart disorder/ blood or heart disorder/condition type: mitral valve prolapse").On (b)(6) 2014, the patient experienced bladder disorder ("bladder/urinary problems : bladder problems") and vaginal discharge ("vaginal discharge") and was found to have weight increased ("weight gain"), 3 years 1 month after insertion of essure.In (b)(6) 2014, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping").In (b)(6) 2018, the patient experienced heavy menstrual bleeding ("menorrhagia (heavy menstrual bleeding").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria hospitalization and medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), cystitis ("infection (bladder urinary tract/vaginal) type: bladder"), urinary tract infection ("infection (bladder urinary tract/vaginal) type: uti"), vaginal infection ("infection (bladder urinary tract/vaginal) type: vaginal"), headache ("headaches"), back pain ("lower back pain"), chest pain ("chest pain"), vulvovaginal pain ("vaginal pain"), urinary tract disorder ("urinary problems or changes"), iron deficiency ("iron deficiency") and oropharyngeal pain ("sore throat").The patient was treated with ibuprofen, surgery (to remove essure) and blood transfusion.Essure was removed.At the time of the report, the abdominal pain lower, genital haemorrhage, dysmenorrhoea, mitral valve prolapse, iron deficiency anaemia, heavy menstrual bleeding, bladder disorder, vaginal discharge, migraine, weight increased, vaginal haemorrhage, cystitis, urinary tract infection, vaginal infection, headache, back pain, chest pain, vulvovaginal pain, urinary tract disorder, iron deficiency and oropharyngeal pain outcome was unknown.The reporter considered abdominal pain lower, back pain, bladder disorder, chest pain, cystitis, dysmenorrhoea, genital haemorrhage, headache, heavy menstrual bleeding, iron deficiency, iron deficiency anaemia, migraine, mitral valve prolapse, oropharyngeal pain, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal pain and weight increased to be related to essure.The reporter commented: as per mr, discrepancy noted in date of insertion: (b)(6) 2011 attention turned to the right ostia, micro insert placed with 5 rings remaining in the endometrial cavity.In a similar fashion, the micro insert was placed in the left ostia with 6 rings remaining in the endometrial cavity.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 41.6 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2021: mr received.Reporter information and rcc 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.

• 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: 9161277
• MDR Text Key: 168795796
• Report Number: 2951250-2019-09701
• 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: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA; DEPO PROVERA; IRON; IRON
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 31 YR
• Patient Weight: 113