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

Model Number ESS305

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165)

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 ("essure devices that have been inserted and in fact only one was visible perforated the fundus of uterus by approximately 0.5 cm") and embedded device ("ultrasound scan today suggests that these are both placed within the myometrium") in a female patient who had essure inserted for female sterilisation.Product or product use issues identified: device removal failed ("could not be extruded into either the pelvic r the uterine cavities").The patient had a medical history of vitamin d deficiency in 2019 and fibromyalgia, heavy menstrual bleeding, dyspareunia, endometriosis, adenomyosis, uterine fibroid, vaginal discharge, nausea, back pain, vomiting, back pain, parity 2, altered mood, anxiety state, amenorrhoea, abdominal pain, haemorrhoids, anxiety and depression.Previously administered products included: primolut [norethisterone], methotrexate and mirena.Concurrent conditions were listed as ectopic pregnancy since 2004 as well as uti, sinusitis, menorrhagia and endometriosis.On (b)(6) 2012, the patient had essure inserted.An unknown time later she experienced uterine perforation (seriousness criterion intervention required) and embedded device (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic ovarian cystectomy & bilateral salpingectomy).The reporter considered embedded device and uterine perforation to be related to essure administration.The reporter commented: discrepancy noted in essure sterilisation on (b)(6) 2012 (as per mr) on (b)(6) 2012 (as per mr).On (b)(6) 2013, patient underwent laparoscopic bilateral salpingectorny last week.She was attending this week for review of her x-ray film which confirmed the presence of only two essure sterilisation devices.An ultrasound scan today suggests that these are both placed within the myometrium and therefore will require no further treatment.On (b)(6) 2019: dr.Am not entirely sure that the essure devices are responsible for her symptoms on (b)(6) 2019 : transvaginal ultrasound - essure devices not seen.On (b)(6) 2021 : dr.Note her history of bilateral salpingectomies laparoscopically for her previous essure insertion.She states that her essure remains in situ despite the salpingectomies as they were adherent to her uterus.On (b)(6) 2021: trans-vaginal scan today - one of her essure coils was seen.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound scan] on (b)(6) 2013: both placed within the myometrium and therefore will require no further treatment [x-ray] on (b)(6) 2013: presence of only two essure sterilization devices.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 15-nov-2023: medical record received.Event injury nos is replaced with device embedded.Medical history , concomitant & reporter information updated.Lab data added.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 (subsequently medically confirmed) and describes the occurrence of embedded device ("ultrasound scan today suggests that these are both placed within the myometrium") in a female patient who had essure inserted for female sterilisation.Product or product use issues identified: device removal failed ("could not be extruded into either the pelvic r the uterine cavities").The patient had a medical history of vitamin d deficiency in 2019 and fibromyalgia, heavy menstrual bleeding, dyspareunia, endometriosis, adenomyosis, uterine fibroid, vaginal discharge, nausea, back pain, vomiting, back pain, parity 2, altered mood, anxiety state, amenorrhoea, abdominal pain, haemorrhoids, anxiety and depression.Previously administered products included: primolut [norethisterone], methotrexate and mirena.Concurrent conditions were listed as ectopic pregnancy since 2004 as well as uti, sinusitis, menorrhagia and endometriosis.On (b)(6) 2012, the patient had essure inserted.An unknown time later she experienced embedded device (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic ovarian cystectomy & bilateral salpingectomy).The reporter considered embedded device to be related to essure administration.The reporter commented: discrepancy noted in essure sterilisation on (b)(6) 2012 (as per mr) (b)(6) 2012 (as per mr) (b)(6) 2012: essures deployed right- 2 rings left ¿ 5 first right essure insertion twisted and was removed (b)(6) 2013: patient admitted for laparoscopic ovarian cystectomy and left salpingectomy.The procedure that was undertaken this evening has in fact turned out to be a laparoscopic adheslolysls with bilateral salpingectomy and hysteroscopy.Note patient's complex recent history.Laparoscopy this evening failed to demonstrate: he numerous essure devices that have been inserted and in fact only one was visible perforated the fundus of uterus by approximately 0.5 cm.This was fixed and could not be extruded into either the pelvic r the uterine cavities.Bilateral salpingectomy was undertaken and no essure device was seen in either tube.The hysteroscopy was then performed which similarly failed to demonstrate any evidence of an essure device trailing from the cornu into the uterus.(b)(6) 2013 - patient underwent laparoscopic bilateral salpingectomy last week.She was attending this week for review of her x-ray film which confirmed the presence of only two essure sterilisation devices.An ultrasound scan today suggests that these are both placed within the myometrium and therefore will require no further treatment.(b)(6) 2019: dr am not entirely sure that the essure devices are responsible for her symptoms (b)(6) 2019 : transvaginal ultrasound - essure devices not seen (b)(6) 2019: patient was recently seen with us again with issues regarding.Pelvic pain, dyspareunia and heavy menstrual bleeding.She previously had essure sterilization in 2012 and then subsequently had a laparoscopic bilateral salpingectomy in 2013.She was commenced on gnrh analogues with add back hrt at her last clinic appointment to see how her symptoms responded to this and she has been amencirrhoeic for the past 2 months but states that there has been absolutely no impro.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound scan] on (b)(6) 2013: both placed within the myometrium and therefore will require no further treatment; on (b)(6) 2019: transvaginal ultrasound: fibroid uterus 7.8 mm no ovarian cyst, essure devices not seen [x-ray] on (b)(6) 2013: presence of only two essure sterilization devices.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The following amendment was made: internal correction of event coding.Uterine perforation deleted.Lab data added.No new follow-up information was received from the reporter.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 (subsequently medically confirmed) and describes the occurrence of embedded device ("ultrasound scan today suggests that these are both placed within the myometrium") in a female patient who had essure inserted for female sterilisation.Product or product use issues identified: device removal failed ("could not be extruded into either the pelvic r the uterine cavities").The patient had a medical history of vitamin d deficiency in 2019 and fibromyalgia, heavy menstrual bleeding, dyspareunia, endometriosis, adenomyosis, uterine fibroid, vaginal discharge, nausea, back pain, vomiting, back pain, parity 2, altered mood, anxiety state, amenorrhoea, abdominal pain, haemorrhoids, anxiety and depression.Previously administered products included: primolut [norethisterone], methotrexate and mirena.Concurrent conditions were listed as ectopic pregnancy since 2004 as well as uti, sinusitis, menorrhagia and endometriosis.On (b)(6)2012, the patient had essure inserted.An unknown time later she experienced embedded device (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic ovarian cystectomy & bilateral salpingectomy).The reporter considered embedded device to be related to essure administration.The reporter commented: discrepancy noted in essure sterilisation on (b)(6) 2012 (as per (b)(6) on (b)(6) 2012 (as per (b)(6) on (b)(6)2012: essures deployed right- 2 rings left ¿ 5 first right essure insertion twisted and was removed on (b)(6) 2013: patient admitted for laparoscopic ovarian cystectomy and left salpingectomy.The procedure that was undertaken this evening has in fact turned out to be a laparoscopic adheslolysls with bilateral salpingectomy and hysteroscopy.Note patient's complex recent history.Laparoscopy this evening failed to demonstrate: he numerous essure devices that have been inserted and in fact only one was visible perforated the fundus of uterus by approximately 0.5 cm.This was fixed and could not be extruded into either the pelvic r the uterine cavities.Bilateral salpingectomy was undertaken and no essure device was seen in either tube.The hysteroscopy was then performed which similarly failed to demonstrate any evidence of an essure device trailing from the cornu into the uterus.On (b)(6) 2013 - patient underwent laparoscopic bilateral salpingectorny last week.She was attending this week for review of her x-ray film which confirmed the presence of only two essure sterilisation devices.An ultrasound scan today suggests that these are both placed within the myometrium and therefore will require no further treatment.On (b)(6) 2019: dr am not entirely sure that the essure devices are responsible for her symptoms on (b)(6) 2019 : transvaginal ultrasound - essure devices not seen on (b)(6) 2019: patient was recently seen with us again with issues egarding.Pelvic pain, dyspareunia and heavy menstrual bleeding.She previously had essure sterilization in 2012 and then subsequently had a laparoscopic bilateral salpingectomy in 2013.She was commenced on gnrh analogues with add back hrt at her last clinic appointment to see how her symptoms responded to this and she has been amencirrhoeic for the past 2 months but states that there has been absolutely no impro.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound scan] on (b)(6) 2013: both placed within the myometrium and therefore will require no further treatment; on (b)(6) 2019: transvaginal ultrasound: fibroid uterus 7.8 mm no ovarian cyst, essure devices not seen [x-ray] on (b)(6) 2013: presence of only two essure sterilization devices quality-safety evaluation of ptc: for essure: 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: 20-dec-2023: quality safety evaluation of ptc.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.

• 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: 18187769
• MDR Text Key: 328739820
• Report Number: 2951250-2023-03376
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2023
• 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 Sex: Female