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); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pain") in an adult female patient who had essure inserted (lot no.B09702).There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2014, the patient had essure inserted.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required).The patient will be treated with surgery (recommended for hysterectomy).At the time of the report, the outcome of the event was unknown.The reporter considered pelvic pain to be related to essure administration.The reporter commented: recommended for hysterectomy.Awaiting date.Lot number: b09702, manufacture date: 2013-03, expiration date: 2016-03.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: (b)(6) 2022: summons received.: event- 'injury nos' replaced by 'pelvic pain female" pregnancy changed from 'unk' to "no".Rcc updated (recommended for hysterectomy.Awaiting date.) - case became serious 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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain") and uterine perforation ("mr which showed possibility that essure coil on the right side was projecting beyond the myometrium which raises concerns of perforation") in an adult female patient who had essure inserted (lot no.B09702) for female sterilisation.The patient had a medical history of shortness of breath, mastalgia, parity 4, acute bronchitis, weight gain, vaginal bleeding, hypothyroidism, trochanteric bursitis, leg pain, abdominal discomfort, low back pain, adenomyosis, fibromyalgia, uterine prolapse, sleep apnoea and vitamin b12 deficiency.On (b)(6) 2014, the patient had essure inserted.An unknown time later she experienced pelvic pain (seriousness criteria medically important and intervention required) and uterine perforation (seriousness criterion medically important).The patient was treated with surgery (recommended for hysterectomy).Essure was removed.At the time of the report, the outcomes for these events were unknown.The reporter considered pelvic pain and uterine perforation to be related to essure administration.The reporter commented: recommended for hysterectomy.Awaiting date.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound scan] on (b)(6) 2021: essure sterilization clips in upper uterus.Lot number: b09702, manufacture date: 2013-03 and expiration date: 2016-03.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 08-aug-2022: quality safety evaluation of ptc.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 originally reported by a lawyer, on behalf of a consumer, (subsequently medically confirmed) and describes the occurrence of pelvic pain ("pain") and uterine perforation ("mr, which showed possibility, that essure coil on the right side, was projecting beyond the myometrium.Which raises concerns of perforation").In an adult female patient, who had essure inserted (lot no.B09702) for female sterilisation.The patient had a medical history of shortness of breath, mastalgia, parity 4, acute bronchitis, weight gain, vaginal bleeding, hypothyroidism, trochanteric bursitis, leg pain, abdominal discomfort, low back pain, adenomyosis, fibromyalgia, uterine prolapse, sleep apnoea and vitamin b12 deficiency.On (b)(6) 2014, the patient had essure inserted.An unknown time later, she experienced pelvic pain (seriousness criteria medically important and intervention required) and uterine perforation (seriousness criteria medically important and intervention required).The patient was treated with surgery (recommended for hysterectomy).Essure was removed.At the time of the report, the outcomes for these events were unknown.The reporter considered, pelvic pain and uterine perforation to be related to essure administration.The reporter commented: recommended for hysterectomy.Awaiting date.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound scan] on (b)(6) 2021, essure sterilization clips in upper uterus.Lot number#: b09702, manufacture date: 2013-03, expiration date: 2016-03.Quality safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: (b)(6) 2022, medical record received: event "mr, which showed possibility, that essure coil on the right side was projecting beyond the myometrium.Which, raises concerns of perforation", reporter, medical history, lab data added.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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("persistent pelvic pain") and uterine perforation ("coil on right side was projecting beyond the myometrium, concerns of perforation") in an adult female patient who had essure inserted (lot no.B09702) for female sterilisation.The patient had a medical history of melasma and lupus erythematosus (subacute) in 2014 and shortness of breath, mastalgia, parity 4, acute bronchitis, weight gain, vaginal bleeding, hypothyroidism, trochanteric bursitis, leg pain, abdominal discomfort, low back pain, adenomyosis, fibromyalgia, uterine prolapse, sleep apnoea and vitamin b12 deficiency.Concurrent conditions were listed as depression, polycystic ovarian syndrome and fibromyalgia.On (b)(6) 2014, the patient had essure inserted.An unknown time later she experienced pelvic pain (seriousness criterion intervention required) and uterine perforation (seriousness criterion intervention required).The patient was treated with surgery (hysterectomy due (b)(6) 2023).At the time of the report, the outcomes for these events were unknown.The reporter considered pelvic pain and uterine perforation to be related to essure administration.The reporter commented: recommended for hysterectomy.Awaiting date.Pain now also developed on left side, described as intermittent, sharp, and worse on movement.O (b)(6) 2023: due hysterectomy tomorrow.Diagnostic results (normal ranges are provided in parenthesis if available): [magnetic resonance imaging] in 2021: showed possibility that essure coil on right side was projecting beyond the myometrium which raises concerns of perforation [ultrasound scan] on (b)(6) 2021: essure sterilization clips in upper uterus.Lot number: b09702.Manufacture date: 2013-03.Expiration date: 2016-03.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 26-apr-2023: quality safety evaluation of ptc.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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("persistent pelvic pain") and uterine perforation ("coil on right side was projecting beyond the myometrium, concerns of perforation") in an adult female patient who had essure inserted (lot no.B09702) for female sterilisation.The patient had a medical history of melasma and lupus erythematosus (subacute) in 2014 and shortness of breath, mastalgia, parity 4, acute bronchitis, weight gain, vaginal bleeding, hypothyroidism, trochanteric bursitis, leg pain, abdominal discomfort, low back pain, adenomyosis, fibromyalgia, uterine prolapse, sleep apnoea and vitamin b12 deficiency.Concurrent conditions were listed as depression, polycystic ovarian syndrome and fibromyalgia.On (b)(6) 2014, the patient had essure inserted.An unknown time later she experienced pelvic pain (seriousness criterion intervention required) and uterine perforation (seriousness criterion intervention required).The patient was treated with surgery (hysterectomy due (b)(6) 2023).At the time of the report, the outcomes for these events were unknown.The reporter considered pelvic pain and uterine perforation to be related to essure administration.The reporter commented: recommended for hysterectomy.Awaiting date.Pain now also developed on left side, described as intermittent, sharp, and worse on movement.(b)(6) 2023: due hysterectomy tomorrow.Diagnostic results (normal ranges are provided in parenthesis if available): [magnetic resonance imaging] in 2021: showed possibility that essure coil on right side was projecting beyond the myometrium which raises concerns of perforation [ultrasound scan] on (b)(6) 2021: essure sterilization clips in upper uterus.Lot number: b09702 manufacture date: 2013-03 expiration date: 2016-03.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 13-apr-2023: concomitant diseases added, event pain was amended to persistent pelvic pain, lab data mri added.Planned removal date reported.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 originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of pelvic pain ("persistent pelvic pain"), uterine perforation ("coil on right side was projecting beyond the myometrium, concerns of perforation") and device dislocation ("device migration with associated complications including bladder, bowel and urinary problems;") in an adult female patient who had essure inserted (lot no.B09702) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of melasma and lupus erythematosus (subacute) in 2014 and irritable bowel syndrome, depression, anxiety, appendicitis, abdominal pain, shortness of breath, mastalgia, parity 4, acute bronchitis, weight gain, vaginal bleeding, hypothyroidism, trochanteric bursitis, leg pain, abdominal discomfort, low back pain, adenomyosis, fibromyalgia, uterine prolapse, sleep apnoea and vitamin b12 deficiency.Concurrent conditions were listed as depression, polycystic ovarian syndrome and fibromyalgia.On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2023.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), uterine perforation (seriousness criterion intervention required), device dislocation (seriousness criterion medically important), bladder disorder ("bladder problem"), gastrointestinal disorder ("bowel problem"), urinary tract disorder ("urinary problems"), device intolerance ("inability to tolerate the device") and genital haemorrhage ("abnormal bleeding") and was found to have weight increased ("weight gain").The patient was treated with surgery (total laparoscopic hysterectomy and bilateral salpingooophorectomy * bilateral salpingo-oophorectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered bladder disorder, device dislocation, device intolerance, gastrointestinal disorder, genital haemorrhage, pelvic pain, urinary tract disorder, uterine perforation and weight increased to be related to essure administration.The reporter commented: recommended for hysterectomy.Awaiting date.Pain now also developed on left side, described as intermittent, sharp, and worse on movement.(b)(6) 2023: due hysterectomy tomorrow.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2020: confirmed acute appendicitis, with an apparent limb of an intrauterine device extending into the myometrium.The scan was reviewed by gynecology who concluded there was no iud, but rather there was a coil that may appear as the above.They concluded a review was not required.[magnetic resonance imaging] in 2021: showed possibility that essure coil on right side was projecting beyond the myometrium which raises concerns of perforation [pathology test] on (b)(6) 2023: specimen: uterus, cervix, ovaries, bilateral, fallopian tubes, clinical information total laparoscopic hysterectomy and bilateral salpingo oophorectomy pelvic pain, essure sterilization in the past.Last cervical smear test in 2021 was hpv positive mri described adenomyosis diagnoses: uterus, cervix both ovaries and fallopian tubes- adenomyosis gross description: the right fallopian tube is 6 cm long including fimbria and appears unremarkable.The right ovary is 3 x 2.5 x 1.5 cm and appears cut surface hemorrhagic cyst 1.5 cm.The left fallopian tube is 6 cm long including fimbria, and appears cut surface hemorrhagic and unremarkable there is no evidence of sinister gynecological origin.The histology result confirmed significant adenomyosis.[ultrasound scan] on (b)(6) 2021: essure sterilization clips in upper uterus [ultrasound scan vagina] on (b)(6) 2023: abdominal pain, bloatiness sensation at risk of uterine perforation due to right essure oil migrating however, now also experiencing pain on the left findings: anteverted uterus.As previously reported essure sterilization clips noted in the upper uterus; on (b)(6) 2023: findings: ta scan only.Tv scan declined.Total hysterectomy and bi-lateral oophorectomy noted.Normal sonographic appearances of the vaginal vault.No adnexal masses or free fluid lot number: b09702 manufacture date: 2013-03 expiration date: 2016-03.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 29-dec-2023: medical record received.New events device migration, bladder, bowel and urinary problems , inability to tolerate the device,.Abnormal bleeding, weight gain added.Essure removal date , new reporter , lab data, medical history added.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 15139837
• MDR Text Key: 296985781
• Report Number: 2951250-2022-00932
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Model Number: ESS305
• Device Lot Number: B09702
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2023
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female