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 Uterine Perforation (2121)

Event Date 04/15/2015

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of uterine perforation ("left device crosses the myometrium, crosses the myometrium in the cornua noted on transvaginal ultrasound on day of insertion") in a 35 year-old female patient who had essure inserted (lot no.C13140) for female sterilisation.The patient had a medical history of iliac fossa pain on (b)(6) 2022, pancreatitis on (b)(6) 2022, gallstones and umbilical hernia on (b)(6) 2019, ovarian cyst ruptured and epigastric pain on (b)(6) 2019, dizziness on (b)(6), cholecystitis and abdominal pain on (b)(6) 2018, smoker (she smokes up to 10 cigarettes per day) in 1991 and hysterotomy, hiatus hernia, gastritis, parity 3 (patient has had 3 previous normal births, the last baby delivered 13 years ago), cholecystectomy and alcohol use (soci).Previously administered products included: nova t 380.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 768 days after essure insertion, she experienced uterine perforation (seriousness criterion medically important).Essure treatment was not changed.At the time of the report, the outcome of the event was unknown.The reporter considered uterine perforation to be related to essure administration.The reporter commented: on waiting list for removal.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: normal pancreas.[ultrasound pelvis] on (b)(6) 2022: under limitation outlined.[ultrasound scan vagina] on (b)(6) 2015: both the right and left essure device present and appear normally placed.Right device is in contact with the uteroserosal tubal junction, left device crosses the myometrium crosses the myometrium in the cornua.No free pelvic fluid.Impression: normal bilateral essure placement tests confirm bilateral tubal occlusion.Right ovary contained a 30 mm simple cyst otherwise normal.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 04-aug-2023: medical record received.Case became serious incident.Event injury nos is replaced with uterine perforation.Lot number added.Medical history , lab data updated.New reporters added.Patient aka name 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 (subsequently medically confirmed) and describes the occurrence of uterine perforation ("left device crosses the myometrium, crosses the myometrium in the cornua noted on transvaginal ultrasound on day of insertion") in a 35 year-old female patient who had essure inserted (lot no.C13140) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of iliac fossa pain on (b)(6) 2022, pancreatitis on (b)(6) 2022, gallstones and umbilical hernia on (b)(6) 2019, ovarian cyst ruptured and epigastric pain on 04-mar-2019, dizziness on (b)(6) 2019, cholecystitis and abdominal pain on (b)(6) 2018, smoker (she smokes up to 10 cigarettes per day) in 1991 and hysterotomy, hiatus hernia, gastritis, parity 3 (patient has had 3 previous normal births, the last baby delivered 13 years ago), cholecystectomy and alcohol use (soci).Previously administered products included: nova t 380.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 768 days after essure insertion, she experienced uterine perforation (seriousness criterion medically important).An unknown time later she experienced pelvic pain ("chornic pain") and genital haemorrhage ("abnormal bleeding").Essure treatment was not changed.At the time of the report, the outcome of uterine perforation was unknown.The reporter considered genital haemorrhage, pelvic pain and uterine perforation to be related to essure administration.The reporter commented: on waiting list for removal.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: normal pancreas.[ultrasound pelvis] on (b)(6) 2022: under limitation outlined.[ultrasound scan vagina] on (b)(6) 2015: both the right and left essure device present and appear normally placed.Right device is in contact with the uteroserosal tubal junction, left device crosses the myometrium crosses the myometrium in the cornua.No free pelvic fluid.Impression: normal bilateral essure placement tests confirm bilateral tubal occlusion.Right ovary contained a 30 mm simple cyst otherwise normal.Batch: noc13140.Production date: 2014-01-16.Expiration date: 2017-01-31.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: 17-aug-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 uterine perforation ("left device crosses the myometrium, crosses the myometrium in the cornua noted on transvaginal ultrasound on day of insertion") in a 35 year-old female patient who had essure inserted (lot no.C13140) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of iliac fossa pain on (b)(6) 2022, pancreatitis on (b)(6) 2022, gallstones and umbilical hernia on (b)(6) 2019, ovarian cyst ruptured and epigastric pain on (b)(6) 2019, dizziness on (b)(6) 2019, cholecystitis and abdominal pain on (b)(6) 2018, smoker (she smokes up to 10 cigarettes per day) in 1991 and hysterotomy, hiatus hernia, gastritis, parity 3 (patient has had 3 previous normal births, the last baby delivered 13 years ago), cholecystectomy and alcohol use (soci).Previously administered products included: nova t 380.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 768 days after essure insertion, she experienced uterine perforation (seriousness criterion medically important).An unknown time later she experienced pelvic pain ("chornic pain") and genital haemorrhage ("abnormal bleeding").Essure treatment was not changed.At the time of the report, the outcome of uterine perforation was unknown.The reporter considered genital haemorrhage, pelvic pain and uterine perforation to be related to essure administration.The reporter commented: on waiting list for removal.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: normal pancreas [ultrasound pelvis] on (b)(6) 2022: under limitation outlined [ultrasound scan vagina] on (b)(6) 2015: both the right and left essure device present and appear normally placed.Right device is in contact with the uteroserosal tubal junction, left device crosses the myometrium crosses the myometrium in the cornua.No free pelvic fluid.Impression: normal bilateral essure placement tests confirm bilateral tubal occlusion.Right ovary contained a 30 mm simple cyst otherwise normal.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 04-aug-2023: summons received.Events pelvic pain female & abnormal bleeding were added.New reporter 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 (subsequently medically confirmed) and describes the occurrence of uterine perforation ("left device crosses the myometrium, crosses the myometrium in the cornua noted on transvaginal ultrasound on day of insertion") in a 35 year-old female patient who had essure inserted (lot no.C13140, c51344) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of iliac fossa pain on (b)(6) 2022, pancreatitis on (b)(6) 2022, gallstones and umbilical hernia on (b)(6) 2019, ovarian cyst ruptured and epigastric pain on (b)(6) 2019, dizziness on (b)(6) 2019, cholecystitis and abdominal pain on (b)(6) 2018, smoker (she smokes up to 10 cigarettes per day) in 1991 and back pain, cholecystectomy, epigastric pain, discharge vaginal, vomiting, nausea, hysterotomy, hiatus hernia, gastritis, parity 3 (patient has had 3 previous normal births, the last baby delivered 13 years ago), cholecystectomy and alcohol use (soci).Previously administered products included: nova t 380.Concurrent conditions were listed as lower abdominal pain, cystitis and uti.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 90 days after essure insertion, she experienced uterine perforation (seriousness criterion intervention required).Essure was removed on (b)(6) 2023.On unknown date she experienced pelvic pain ("chornic pain"), genital haemorrhage ("abnormal bleeding"), device intolerance ("inability to tolerate the device;"), dyspareunia ("dyspareunia") and mental disorder ("psychological issues").The patient was treated with diclofenac and paracetamol as well as surgery (bilateral salpingectomy).At the time of the report, the outcomes for uterine perforation, device intolerance, dyspareunia and mental disorder were unknown.The reporter considered device intolerance, dyspareunia, genital haemorrhage, mental disorder, pelvic pain and uterine perforation to be related to essure administration.The reporter commented: discrepant date for hysterectomy "4 years ago" in visit on (b)(6) 2018.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: normal pancreas [ultrasound pelvis] on (b)(6) 2022: under limitation outlined [ultrasound scan vagina] on (b)(6) 2015: both the right and left essure device present and appear normally placed.Right device is in contact with the uteroserosal tubal junction, left device crosses the myometrium crosses the myometrium in the cornua.No free pelvic fluid.Impression: normal bilateral essure placement tests confirm bilateral tubal occlusion.Right ovary contained a 30 mm simple cyst otherwise normal.Batch no~c13140 production date~2014-01-16 expiration date 2017-01-31.Batch no~c51344 production date~2014-05-06 expiration date 2017-05-31.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: 24-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.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of uterine perforation ("left device crosses the myometrium, crosses the myometrium in the cornua noted on transvaginal ultrasound on day of insertion") in a 35 year-old female patient who had essure inserted (lot no.C13140, c51344) for female sterilisation.Additional non-serious events are detailed below.The patient had a medical history of iliac fossa pain on (b)(6) 2022, pancreatitis on (b)(6) 2022, gallstones and umbilical hernia on (b)(6) 2019, ovarian cyst ruptured and epigastric pain on (b)(6) 2019, dizziness on (b)(6) 2019, cholecystitis and abdominal pain on (b)(6) 2018, smoker (she smokes up to 10 cigarettes per day) in 1991 and back pain, cholecystectomy, epigastric pain, discharge vaginal, vomiting, nausea, hysterotomy, hiatus hernia, gastritis, parity 3 (patient has had 3 previous normal births, the last baby delivered 13 years ago), cholecystectomy and alcohol use (soci).Previously administered products included: nova t 380.Concurrent conditions were listed as lower abdominal pain, cystitis and uti.On (b)(6) 2015, the patient had essure inserted.On (b)(6) 2015, 90 days after essure insertion, she experienced uterine perforation (seriousness criterion intervention required).Essure was removed on (b)(6) 2023.An unknown time later she experienced pelvic pain ("chronic pain"), genital haemorrhage ("abnormal bleeding"), device intolerance ("inability to tolerate the device;"), dyspareunia ("dyspareunia") and mental disorder ("psychological issues").The patient was treated with diclofenac and paracetamol as well as surgery (bilateral salpingectomy).At the time of the report, the outcomes for uterine perforation, device intolerance, dyspareunia and mental disorder were unknown.The reporter considered device intolerance, dyspareunia, genital haemorrhage, mental disorder, pelvic pain and uterine perforation to be related to essure administration.The reporter commented: discrepant date for hysterectomy "4 years ago" in visit on (b)(6) 2018.Diagnostic results (normal ranges are provided in parenthesis if available): [computerised tomogram] on (b)(6) 2022: normal pancreas.[ultrasound pelvis] on (b)(6) 2022: under limitation outlined.[ultrasound scan vagina] on (b)(6) 2015: both the right and left essure device present and appear normally placed.Right device is in contact with the uteroserosal tubal junction, left device crosses the myometrium crosses the myometrium in the cornua.No free pelvic fluid.Impression: normal bilateral essure placement tests confirm bilateral tubal occlusion.Right ovary contained a 30 mm simple cyst otherwise normal.Batch no: c13140.Production date: 2014-01-16.Expiration date: 2017-01-31.The most recent follow-up information incorporated above includes data received on: 08-dec-2023: medical record received.New events device intolerance, psychological issues, dyspareunia are added.Lot number, essure removal date and details updated.Medical history, concomitant drugs and reporter information 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.

• 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: 17508079
• MDR Text Key: 320857388
• Report Number: 2951250-2023-02787
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C13140, C51344
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Date Device Manufactured: 01/16/2014
• 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): Other; Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female