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 Anemia (1706); Genital Bleeding (4507)

Event Date 06/27/2022

Event Type  Injury  

Event Description

This 52-year-old female subject was enrolled in a company-sponsored interventional study titled: "use of transvaginal ultrasound to confirm essure micro-insert placement in women: demonstration of effectiveness" (protocol: 16974).The subject (patient id: (b)(6)) had fallopian tube occlusion insert inserted for female sterilisation.The case describes the occurrence of blood loss anaemia ("anemia") and abnormal uterine bleeding ("abnormal uterine bleeding").There was no information on the subject's medical history or concurrent conditions.On an unknown date, the subject had fallopian tube occlusion insert inserted.On (b)(6) 2022 she experienced blood loss anaemia (seriousness criterion medically important) and abnormal uterine bleeding (seriousness criterion medically important).The subject was treated with b12-vitamiin (cyanocobalamin) and iron.On (b)(6) 2023, all of the events had resolved.The investigator considered abnormal uterine bleeding and blood loss anaemia to be related to fallopian tube occlusion insert administration.The reporter commented: abnormal uterine bleeding resulting in low hemoglobin requiring iud mirena to prevent future blood loss anemia.Hemoglobin was 7.2,requiring iron infusions and b12 shots.This was performed by a doctor not on the study,and unaware of protocols guidelines.This was found out at 10 year visit.Follow-up ((b)(6) 2023): abnormal uterine bleeding occurred resulting in anemia possible adenomiose, leading to heavy bleeding resulting in severe anemia.Resolved with mirena iud.Bleeding resolved with iron transfusions.This was found out at year.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.684 kg/sqm.Quality-safety evaluation of ptc: for fallopian tube occlusion insert: 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.The most recent follow-up information incorporated above includes data received on: 18-apr-2023: adverse event "abnormal uterine bleeding" added to the case; additional context informed in comments.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 52-year-old female subject was enrolled in a company-sponsored interventional study titled: "use of transvaginal ultrasound to confirm essure micro-insert placement in women: demonstration of effectiveness" (protocol: (b)(4)).The subject (patient id: (b)(6)) had fallopian tube occlusion insert (lot no.893029) inserted for female sterilisation.The case describes the occurrence of abnormal uterine bleeding ("abnormal uterine bleeding") and iron deficiency anaemia ("anemia").As concurrent condition the report mentioned overweight.On an unknown date, the subject had fallopian tube occlusion insert inserted.On (b)(6) 2022 she experienced abnormal uterine bleeding (seriousness criterion medically important) and iron deficiency anaemia (seriousness criterion medically important).The subject was treated with mirena (levonorgestrel), b12-vitamiin (cyanocobalamin) and iron.On (b)(6) 2023, all of the events had resolved.The investigator considered abnormal uterine bleeding and iron deficiency anaemia to be related to fallopian tube occlusion insert administration.The reporter commented: abnormal uterine bleeding resulting in low hemoglobin requiring iud mirena to prevent future blood loss anemia.Hemoglobin was 7.2, requiring iron infusions and b12 shots.Anemia has resolved with insertion of mirena iud and bleeding resolved with iron transfusions.This was performed by a doctor not on the study, and unaware of protocols guidelines.This was found out at 10 year visit.Follow-up on 18-apr-2023: abnormal uterine bleeding occurred resulting in anemia, possible adenomyosis, leading to heavy bleeding resulting in severe anemia.Resolved with mirena iud.Bleeding resolved with iron transfusions.This was found out at year 10 visit.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.684 kg/sqm.(893209) is invalid: lot number: 893029 valid.Manufacture date: 2011-08.Expiration date: 2014-08.Quality-safety evaluation of ptc: for fallopian tube occlusion insert: 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 52-year-old female subject was enrolled in a company-sponsored interventional study titled: "use of transvaginal ultrasound to confirm essure micro-insert placement in women: demonstration of effectiveness" protocol: (b)(4).The subject patient id: (b)(6) had fallopian tube occlusion insert inserted for female sterilisation.The case describes the occurrence of abnormal uterine bleeding ("abnormal uterine bleeding") and iron deficiency anaemia ("anemia").As concurrent condition the report mentioned overweight.On an unknown date, the subject had fallopian tube occlusion insert inserted.On (b)(6) 2022 she experienced abnormal uterine bleeding (seriousness criterion medically important) and iron deficiency anaemia (seriousness criterion medically important).The subject was treated with mirena (levonorgestrel), b12-vitamin (cyanocobalamin) and iron.On (b)(6) 2023, all of the events had resolved.The investigator considered abnormal uterine bleeding and iron deficiency anaemia to be related to fallopian tube occlusion insert administration.The reporter commented: abnormal uterine bleeding resulting in low hemoglobin requiring iud mirena to prevent future blood loss anemia.Hemoglobin was 7.2, requiring iron infusions and b12 shots.Anemia has resolved with insertion of mirena iud and bleeding resolved with iron transfusions.This was performed by a doctor not on the study, and unaware of protocols guidelines.This was found out at 10 year visit.Follow-up (18-apr-2023): abnormal uterine bleeding occurred resulting in anemia, possible adenomyosis, leading to heavy bleeding resulting in severe anemia.Resolved with mirena iud.Bleeding resolved with iron transfusions.This was found out at year 10 visit.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.684 kg/sqm.Quality-safety evaluation of ptc: for fallopian tube occlusion insert: 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.The most recent follow-up information incorporated above includes data received on: 18-apr-2023: mirena iud was added as treatment for event abnormal uterine bleeding; outcome of anemia was entered as resolved.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 52-year-old female subject was enrolled in a company-sponsored interventional study titled: "use of transvaginal ultrasound to confirm essure micro-insert placement in women: demonstration of effectiveness" (protocol: (b)(4)).The subject (patient id: (b)(6)) had fallopian tube occlusion insert (lot no.893029) inserted for female sterilisation.The case describes the occurrence of abnormal uterine bleeding ("abnormal uterine bleeding") and iron deficiency anaemia ("anemia").As concurrent condition the report mentioned overweight.On (b)(6) 2012, the subject had fallopian tube occlusion insert inserted.On (b)(6) 2022, 3580 days after fallopian tube occlusion insert insertion, she experienced abnormal uterine bleeding (seriousness criterion medically important) and iron deficiency anaemia (seriousness criterion medically important).The subject was treated with mirena (levonorgestrel), b12-vitamiin (cyanocobalamin) and iron.Fallopian tube occlusion insert treatment was not changed.On (b)(6) 2023, all of the events had resolved.The investigator considered abnormal uterine bleeding and iron deficiency anaemia to be related to fallopian tube occlusion insert administration.The reporter commented: abnormal uterine bleeding resulting in low hemoglobin requiring iud mirena to prevent future blood loss anemia.Hemoglobin was 7.2, requiring iron infusions and b12 shots.Anemia has resolved with insertion of mirena iud and bleeding resolved with iron transfusions.This was performed by a doctor not on the study, and unaware of protocols guidelines.This was found out at 10 year visit.Follow-up (18-apr-2023): abnormal uterine bleeding occurred resulting in anemia, possible adenomyosis, leading to heavy bleeding resulting in severe anemia.Resolved with mirena iud.Bleeding resolved with iron transfusions.This was found out at year 10 visit.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 28.684 kg/sqm.(893209) is invalid.Lot number: 893029 valid, manufacture date: 2011-08 & expiration date: 2014-08.Quality-safety evaluation of ptc: for fallopian tube occlusion insert: 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: 09-jun-2023: essure start date provided.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: 16776562
• MDR Text Key: 313652360
• Report Number: 2951250-2023-01808
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Model Number: ESS305
• Device Lot Number: 893029
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2023
• Date Device Manufactured: 08/01/2011
• 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
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 78 KG