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 Problem Insufficient Information (4580)

Event Date 09/14/2022

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("essure removal") in a 46 year-old female patient who had essure inserted for female sterilisation.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2022 she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: as a result of essure, this plaintiff suffered from severe and permanent injuries.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 21-jul-2023: new reporter added, patient's date of birth added, essure removal reported.Based on the available information, a review of our complaint records and other relevant data was 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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("essure removal") in a 46 year-old female patient who had essure inserted (lot no.D01976) for female sterilisation.The patient had a medical history of hyperglycemia, gerd, diabetes mellitus, anxiety depression, breast cancer, gravida i, vaginal delivery (vaginal deliveries 1), parity 1, irregular periods, pelvic pain and.Previously administered products included: mirena.The patient had a family history of diabetes and uterine cancer.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2022, 2778 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required).The patient was treated with surgery (essure removal).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: as a result of essure, this plaintiff suffered from severe and permanent injuries.Discrepancy noted : insertion date as per (b)(6) on (b)(6) 2015, as per mr on (b)(6) 2015, the right implant was placed in standard fashion with 4 coils visible after placement.Diagnostic results (normal ranges are provided in parenthesis if available): [smear cervix] on (b)(6) 2008: normal [ultrasound scan vagina] on (b)(6) 2010: essure implants within normal limits position no adnexal cyst, mass or free fluid is noted the most recent follow-up information incorporated above includes data received on: 18-sep-2023: (b)(6) received : lot number and expiration date, reporters information patient medical history and lab data were added.Product insertion date and rcc updated.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 and describes the occurrence of medical device removal ("essure removal") in a 46 year-old female patient who had essure inserted (lot no.D01976) for female sterilisation.The patient had a medical history of uterus enlarged, dysmenorrhea, menses irregular with excessive bleeding, leiomyoma, hyperglycemia, gerd, diabetes mellitus, anxiety depression, breast cancer, gravida i, vaginal delivery (vaginal deliveries 1), parity 1, irregular periods and pelvic pain.Previously administered products included: mirena.The patient had a family history of diabetes and uterine cancer.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2022, 2791 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.The patient was treated with surgery (total laparoscopic hysterectomy/ bilateral salpingooophorectomy).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: as a result of essure, this plaintiff suffered from severe and permanent injuries.Discrepancy noted: insertion date: as per argus (b)(6) 2015; as per mr (b)(6) 2015.The right implant was placed in standard fashion with 4 coils visible after placement.Diagnostic results (normal ranges are provided in parenthesis if available): [pathology test] on (b)(6) 2022: specimen: uterus, cervix, w/bilateral ovaries fallopian tubes.Final diagnosis: uterus, cervix, and bilateral fallopian tubes and ovaries.(hysterectomy and bilateral salpingooophorectomy): cervix with nabothian cysts and acute and chronic inflammation; disordered proliferative endometrium; adenomyosis; leiomyomata uteri, with no cellular atypia or mitoses; unremarkable fallopian tubes; ovaries with folicular cysts.Clinical information: excessive and frequent menstruation with irregular cycle, intramural leiomyoma of uterus.[smear cervix] on (b)(6) 2008: normal.[ultrasound scan vagina] on (b)(6) 2010: essure implants within normal limits position no adnexal cyst, mass or free fluid is noted.The most recent follow-up information incorporated above includes data received on: 06-nov-2023: reporters, medical history, lab data, removal date, non drug treatment and event onset date 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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("essure removal") in a 46 year-old female patient who had essure inserted (lot no.D01976) for female sterilisation.The patient had a medical history of uterus enlarged, dysmenorrhea, menses irregular with excessive bleeding, leiomyoma, hyperglycemia, gerd, diabetes mellitus, anxiety depression, breast cancer, gravida i, vaginal delivery (vaginal deliveries 1), parity 1, irregular periods and pelvic pain.Previously administered products included: mirena.The patient had a family history of diabetes and uterine cancer.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2022, 2791 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.The patient was treated with surgery (total laparoscopic hysterectomy/bilateral salpingooophorectomy).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.The reporter commented: as a result of essure, this plaintiff suffered from severe and permanent injuries.Discrepancy noted: insertion date: as per argus: (b)(6) 2015.As per mr: (b)(6) 2015.The right implant was placed in standard fashion with 4 coils visible after placement.Diagnostic results (normal ranges are provided in parenthesis if available): [pathology test] on (b)(6) 2022: specimen: uterus, cervix, w/bilateral ovaries fallopian tubes.Final diagnosis: uterus, cervix, and bilateral fallopian tubes and ovaries.(hysterectomy and bilateral salpingooophorectomy): cervix with nabothian cysts and acute and chronic inflammation; disordered proliferative endometrium; adenomyosis; leiomyomata uteri, with no cellular atypia or mitoses; unremarkable fallopian tubes; ovaries with folicular cysts.Clinical information: excessive and frequent menstruation with irregular cycle, intramural leiomyoma of uterus.[smear cervix] on (b)(6) 2008: normal.[ultrasound scan vagina] on (b)(6) 2010: essure implants within normal limits position no adnexal cyst, mass or free fluid is noted.Lot number: d01976.Manufacture date: 2014-08.Expiration date: 2017-08.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: 30-jan-2024: 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: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17539650
• MDR Text Key: 321049035
• Report Number: 2951250-2023-02803
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2017
• Device Model Number: ESS305
• Device Lot Number: D01976
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 46 YR
• Patient Sex: Female