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

Model Number ESS305

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device physical property issue ('the leaching nickel from the essure device prior to its removal') in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.The device physical property issue (seriousness criteria medically significant and intervention required) occurred on an unknown date.The patient was treated with surgery (hysterectomy).Essure was removed.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 pelvic pain ('chronic pelvic pain female') and embedded device ('embedded in the right cornu is a coiled metal device') in an adult female patient who had essure (batch no.816060) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "the leaching nickel from the essure device prior to its removal" (seriousness criteria medically significant and intervention required).The patient's medical history included pain legs, low back pain, pain in joint involving lower leg, migraine, nausea, lower abdominal pain, felt faint, hernia, chest pain, breast cyst, abdominal cramps, constipation, internal hemorrhoids, colonoscopy, ovarian cyst, hemorrhoids, parity 3, lower gastrointestinal bleeding and osteoarthritis.Previously administered products included for an unreported indication: mirena in 2005 and aspirin.Concurrent conditions included bloating, pruritus breast, diverticulosis, stress urinary incontinence, dysmenorrhoea, menstruation abnormal and hypercholesterolemia.Family history included diabetes.Concomitant products included tramadol.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("heavy menstrual bleeding/ menorrhagia") and metal poisoning ("high nickel level").The patient was treated with surgery (hysterectomy,lavh, bilateral salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, embedded device, heavy menstrual bleeding and metal poisoning outcome was unknown.The reporter considered embedded device, heavy menstrual bleeding, metal poisoning and pelvic pain to be related to essure.The reporter commented: insertion details: normal hysteroscopy bilateral essure devices placed-coils not visible one placed-will need hsg-as reported hysterosalpingogram- clinical history: essure on (b)(6) 2013.Coils not visible at end of the procedure.Need to ensure tubal occlusion.Conclusion- no spillage of contrast through the fallopian tubes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: conclusion, no spillage of contrast through the fallopian tubes.Pathology test - on (b)(6) 2018: trace metals: creatinine 15.8 rnrnol/l * nickel 112 nmol/l, nickel/ creatinine ratio 7.1 nmol/rnmol high nickel level.Pathology test - on (b)(6) 2020: uterus:- opened into pieces.¿ size: 95 mm superior to inferior, 55 mm anterior to posterior, 70 mm medial to lateral - serosa: smooth and intact.Cervix:- smooth, 30 x 28 mm , endometrium:- thickness: 1 mm, myometrium:- thickness: 28 mm anterior, 33 mm posterior.No mass lesion tubes:- right 55 mm in length and 6 mm in diameter.- left 55 mm in length and 6 mm in diameter.Both tubes appear normal.Other relevant macroscopic information: - embedded in the right cornu is a coiled metal device, 20 mm in length and 2 mm in diameter.Ultrasound abdomen - on (b)(6) 2012: abdominal exam- mild central abdominal tenderness, no rigidity, no rebound, no guarding normal sound; on (b)(6) 2012: u/s abdominal pain in the mid area,previous hernia.Ultrasound pelvis - on (b)(6) 2014: 1 transabdominal and transvaginal study is performed.Uterus is normal with a volume of 102mls.Endometrium is 6mm thick which is normal.Right ovary has a volume of 8ml.There is a simple cyst or a dominant follicle 16 x 13mm.Left ovary has a volume of 7ml and appeared normal.There is a small amount of free fluid in the pouch of douglas.; on (b)(6) 2016: impression: * possible adenomyosis.* no free fluid or mass lesion.; on (b)(6) 2018: the coils are well visualized within the proximal aspect of the fallopian tubes.Both measure around 2.4cm.The right ovary has a volume of 8cc and the left 7cc.There are randomly scattered follicles on both.No free fluid.Conclusion- sterilization coils within the fallopian tubes.There is no collection or free fluid.No ovarian or adnexal mass.Scarring in the left kidney.No obstruction to the collecting systems; on (b)(6) 2019: ultrasound scan -pelvis-heavy menstrual bleeding and pelvic pain.X-ray - on (b)(6) 2018: there is minimal spurring and joint space loss of the hip joint.In the pelvis there are radio-opaque wires in the region of the fallopian tubes.Left hip joint is similar to the right.There is osteitis pubis at the pubic symphysis and degenerative change at both sacroiliac joints and at the l4 to s1 discs and facets.Comment- evidence of oa of the hip joint.No evidence of trochanteric bursitis.Diagnosis: osteoarthritis; on (b)(6) 2019: plain x-ray- leg right, lumbo-sacral spine back pain pain and swelling in the right leg history of injury.Lot number:816060 manufacture date: 2011-01 expiration date: 2014-01.Quality-safety evaluation of ptc: 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.Most recent follow-up information incorporated above includes: on 28-dec-2021: 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 reported by a lawyer, and describes the occurrence of pelvic pain ('chronic pelvic pain female') and embedded device ('embedded in the right cornu is a coiled metal device').In an adult female patient who had essure (batch no.816060), inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "the leaching nickel from the essure device, prior to its removal" (seriousness criteria medically significant and intervention required).The patient's medical history included: pain legs, low back pain, pain in joint involving lower leg, migraine, nausea, lower abdominal pain, felt faint, hernia, chest pain, breast cyst, abdominal cramps, constipation, internal hemorrhoids, colonoscopy, ovarian cyst, hemorrhoids, parity 3, lower gastrointestinal bleeding and osteoarthritis.Previously administered products, included for an unreported indication: mirena in 2005 and aspirin.Concurrent conditions included: bloating, pruritus breast, diverticulosis, stress urinary incontinence, dysmenorrhoea, menstruation abnormal and hypercholesterolemia.Family history included: diabetes.Concomitant products included: tramadol.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("heavy menstrual bleeding/menorrhagia") and metal poisoning ("high nickel level").The patient was treated with surgery (hysterectomy, lavh, bilateral salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, embedded device, heavy menstrual bleeding and metal poisoning outcome was unknown.The reporter considered embedded device, heavy menstrual bleeding, metal poisoning and pelvic pain to be related to essure.The reporter commented: insertion details: normal hysteroscopy.Bilateral essure devices placed coils not visible one placed.Will need hsg as reported hysterosalpingogram clinical history: essure on (b)(6) 2013.Coils not visible at end of the procedure.Need to ensure tubal occlusion.Conclusion: no spillage of contrast through the fallopian tubes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2013, conclusion: no spillage of contrast through the fallopian tubes.; pathology test: on (b)(6) 2018, trace metals: creatinine 15.8 rnrnol/l nickel 112 nmol/l.Nickel/ creatinine ratio 7.1 nmol/rnmol, high nickel level.; pathology test: on (b)(6) 2020, uterus: opened into pieces, size: 95 mm superior to inferior, 55 mm anterior to posterior, 70 mm medial to lateral.; serosa: smooth and intact, cervix: smooth, 30 x 28 mm, endometrium: thickness: 1 mm, myometrium: thickness 28 mm anterior, 33 mm posterior.No mass lesion.Tubes: right 55 mm in length and 6 mm in diameter.Left 55 mm in length and 6 mm in diameter.Both tubes appear normal.Other relevant macroscopic information: embedded in the right cornu, is a coiled metal device.20 mm in length and 2 mm in diameter.; ultrasound abdomen: on (b)(6) 2012, abdominal exam: mild central abdominal tenderness, no rigidity, no rebound, no guarding normal sound.; on (b)(6) 2012, u/s abdominal pain in the mid area, previous hernia.; ultrasound pelvis: on (b)(6) 2014, 1 transabdominal and transvaginal study is performed.Uterus is normal with a volume of 102mls.Endometrium is 6mm thick, which is normal.Right ovary has a volume of 8ml.There is a simple cyst or a dominant follicle 16 x 13mm.Left ovary has a volume of 7ml and appeared normal.There is a small amount of free fluid in the pouch of douglas.; on (b)(6) 2016, impression: possible adenomyosis, no free fluid or mass lesion.; on (b)(6) 2018, the coils are well visualized within the proximal aspect of the fallopian tubes.Both measure around 2.4cm.The right ovary has a volume of 8cc and the left 7cc.There are randomly scattered follicles on both.No free fluid.Conclusion: sterilization coils within the fallopian tubes.There is no collection or free fluid.No ovarian or adnexal mass.Scarring in the left kidney.No obstruction to the collecting systems.; on (b)(6) 2019, ultrasound scan pelvis: heavy menstrual bleeding and pelvic pain.; x-ray: on (b)(6) 2018, there is minimal spurring.And joint space loss of the hip joint.In the pelvis, there are radio-opaque wires in the region of the fallopian tubes.Left hip joint is similar to the right.There is osteitis pubis at the pubic symphysis.And degenerative change at both sacroiliac joints and at the l4 to s1 discs and facets.Comment: evidence of oa of the hip joint.No evidence of trochanteric bursitis.Diagnosis: osteoarthritis.; (on b)(6) 2019, plain x-ray: leg right, lumbo-sacral spine back pain, pain and swelling in the right leg history of injury.Most recent follow-up information incorporated above includes: on (b)(6) 2021, mr received: lot number was added.New events: embedded device, pelvic pain, heavy menstrual bleeding, metal poisoning added, reporters, dob, insertion date and removal dates, lab data 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('chronic pelvic pain female') and embedded device ('embedded in the right cornu is a coiled metal device') in an adult female patient who had essure (batch no.816060) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "the leaching nickel from the essure device prior to its removal" (seriousness criteria medically significant and intervention required).The patient's medical history included pain legs, low back pain, pain in joint involving lower leg, migraine, nausea, lower abdominal pain, felt faint, hernia, chest pain, breast cyst, abdominal cramps, constipation, internal hemorrhoids, colonoscopy, ovarian cyst, hemorrhoids, parity 3, lower gastrointestinal bleeding and osteoarthritis.Previously administered products included for an unreported indication: mirena in 2005 and aspirin.Concurrent conditions included bloating, pruritus breast, diverticulosis, stress urinary incontinence, dysmenorrhoea, menstruation abnormal and hypercholesterolemia.Family history included diabetes.Concomitant products included tramadol.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("heavy menstrual bleeding/ menorrhagia") and metal poisoning ("high nickel level").The patient was treated with surgery (hysterectomy,lavh, bilateral salpingectomy).Essure was removed on (b)(6) 2020.At the time of the report, the pelvic pain, embedded device, heavy menstrual bleeding and metal poisoning outcome was unknown.The reporter considered embedded device, heavy menstrual bleeding, metal poisoning and pelvic pain to be related to essure.The reporter commented: insertion details: normal hysteroscopy bilateral essure devices placed-coils not visible one placed-will need hsg-as reported hysterosalpingogram- clinical history: essure on (b)(6) 2013.Coils not visible at end of the procedure.Need to ensure tubal occlusion conclusion: no spillage of contrast through the fallopian tubes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2013: conclusion.No spillage of contrast through the fallopian tubes.Pathology test: on (b)(6) 2018: trace metals: creatinine 15.8 rnrnol/l.Nickel 112 nmol/l.Nickel/ creatinine ratio 7.1 nmol/rnmol.High nickel level.Pathology test: on (b)(6)2020: uterus:- opened into pieces size: 95 mm superior to inferior, 55 mm anterior to posterior, 70 mm medial to lateral.Serosa: smooth and intact.Cervix:- smooth, 30 x 28 mm.Endometrium: thickness: 1 mm.Myometrium: thickness: 28 mm anterior, 33 mm posterior.No mass lesion tubes:- right 55 mm in length and 6 mm in diameter.Left 55 mm in length and 6 mm in diameter.Both tubes appear normal.Other relevant macroscopic information: embedded in the right cornu is a coiled metal device, 20 mm in length and 2 mm in diameter.Ultrasound abdomen: on (b)(6) 2012: abdominal exam- mild central abdominal tenderness, no rigidity, no rebound, no guarding normal sound; on (b)(6) 2012: u/s abdominal pain in the mid area,previous hernia.Ultrasound pelvis - on (b)(6) 2014: 1 transabdominal and transvaginal study is performed.Uterus is normal with a volume of 102mls.Endometrium is 6mm thick which is normal.Right ovary has a volume of 8ml.There is a simple cyst or a dominant follicle 16 x 13mm.Left ovary has a volume of 7ml and appeared normal.There is a small amount of free fluid in the pouch of douglas.; on (b)(6) 2016: impression: possible adenomyosis; no free fluid or mass lesion.; on (b)(6) 2018: the coils are well visualized within the proximal aspect of the fallopian tubes.Both measure around 2.4cm.The right ovary has a volume of 8cc and the left 7cc.There are randomly scattered follicles on both.No free fluid.Conclusion- sterilization coils within the fallopian tubes.There is no collection or free fluid.No ovarian or adnexal mass.Scarring in the left kidney.No obstruction to the collecting systems; on (b)(6) 2019: ultrasound scan -pelvis-heavy menstrual bleeding and pelvic pain.X-ray - on (b)(6) 2018: there is minimal spurring and joint space loss of the hip joint.In the pelvis there are radio-opaque wires in the region of the fallopian tubes.Left hip joint is similar to the right.There is osteitis pubis at the pubic symphysis and degenerative change at both sacroiliac joints and at the l4 to s1 discs and facets.Comment- evidence of oa of the hip joint.No evidence of trochanteric bursitis.Diagnosis: osteoarthritis; on (b)(6) 2019: plain x-ray- leg right, lumbo-sacral spine back pain pain and swelling in the right leg history of injury.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 24-dec-2021: 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.

• 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 13024363
• MDR Text Key: 285679372
• Report Number: 2951250-2021-03622
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Model Number: ESS305
• Device Lot Number: 816060
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2021
• Date Device Manufactured: 01/01/2011
• 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
• Treatment: TRAMADOL.; TRAMADOL.; TRAMADOL.
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Female