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 Cyst(s) (1800); Hemorrhage/Bleeding (1888); Pain (1994); Cramp(s) (2193); Anxiety (2328); Depression (2361); Heavier Menses (2666); No Code Available (3191)

Event Date 08/01/2008

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('physical pain/pain pelvic area') and menorrhagia ('abnormal bleeding menorrhagia') in a (b)(6) year-old female patient who had essure (batch no.56-349) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included hip replacement in 2008, bone graft in 2002, smoker, sexually active and endometrial biopsy.Previously administered products included for an unreported indication: ortho tri cyclen.Concurrent conditions included tachycardia, osteonecrosis, arthritis, genital bleeding, menstrual disorder, menometrorrhagia, d & c, endometrial ablation, uterine leiomyoma, nabothian cyst, fibroids, parakeratosis and paratubal cyst.Concomitant products included tropolone since 2007 for tachycardia.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia (seriousness criteria medically significant and intervention required), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia (painful sexual intercourse)").The patient was treated with surgery (ablation d and c and total hysterectomy (uterus and cervix removed)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea and dyspareunia had resolved and the depression and anxiety outcome was unknown.The reporter considered anxiety, depression, dysmenorrhoea, dyspareunia, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: essure device was successfully occluded.Total bilateral occlusion.Fallopian tubes were blocked.No filling of the fallopian tubes is identified following essure placement.Ultrasound pelvis - on an unknown date: hypoechoic lesion within the anterior uterine wall.This may represent a uterine leiomyomata.Correlate clinically.If clinically warranted, an mri examination of the pelvis may be helpful.Nabothian cysts within the cervix.Normal appearing ovaries bilaterally.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-jul-2019: pfs and mr received ¿ case becomes incident.Lot number were added.New events abnormal bleeding (vaginal, menorrhagia), psychological or psychiatric problems condition: depression, mental anguish, dysmenorrhea (cramping) and dyspareunia (painful sexual intercourse) were added.Outcome pelvic pain and severity were updated.Product information indication, insertion and removal date were added.Patient information date of birth and height were added.New reporter and consumer address were added.Medical history, concomitant medication and lab data were added.Incident: 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 non-conformance's data; should any new and reportable information become available as a result, 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 ('physical pain/pain pelvic area') and menorrhagia ('abnormal bleeding menorrhagia') in a 35-year-old female patient who had essure (batch no.56349-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included hip replacement in 2008, bone graft in 2002, smoker, sexually active and endometrial biopsy.Previously administered products included for an unreported indication: ortho tri cyclen.Concurrent conditions included tachycardia, osteonecrosis, arthritis, genital bleeding, menstrual disorder, menometrorrhagia, d & c, endometrial ablation, uterine leiomyoma, nabothian cyst, fibroids, parakeratosis and paratubal cyst.Concomitant products included tropolone since 2007 for tachycardia.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia (seriousness criteria medically significant and intervention required), depression ("psychological or psychiatric problems condition: depression"), anxiety ("mental anguish"), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia (painful sexual intercourse)").The patient was treated with surgery (ablation d and c and total hysterectomy (uterus and cervix removed)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, dysmenorrhoea and dyspareunia had resolved and the depression and anxiety outcome was unknown.The reporter considered anxiety, depression, dysmenorrhoea, dyspareunia, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: essure device was successfully occluded.Total bilateral occlusion.Fallopian tubes were blocked.No filling of the fallopian tubes is identified following essure placement.Ultrasound pelvis - on an unknown date: hypoechoic lesion within the anterior uterine wall.This may represent a uterine leiomyomata.Correlate clinically.If clinically warranted, an mri examination of the pelvis may be helpful.2.Nabothian cysts within the cervix.3.Normal appearing ovaries bilaterally.Lot number reported 56349 is not valid quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: update of information (batch is not valid) incident no valid lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformance's 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 ('physical pain/pain pelvic area'), menorrhagia ('abnormal bleeding menorrhagia/menorrhagia (heavy menstrual bleeding') and genital haemorrhage ('gen.Abnormal bleeding') in a 35-year-old female patient who had essure (batch no.56349-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included hip replacement in 2008, bone graft in 2002, smoker, sexually active and endometrial biopsy.Previously administered products included for an unreported indication: ortho tri cyclen.Concurrent conditions included tachycardia, osteonecrosis, arthritis, genital bleeding, menstrual disorder, menometrorrhagia, d & c, endometrial ablation, uterine leiomyoma, nabothian cyst, fibroids, parakeratosis and paratubal cyst.Concomitant products included tropolone since 2007 for tachycardia.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia (painful sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), depression ("psychological or psychiatric problems condition: depression/psych injury") and anxiety ("mental anguish/psych injury").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("abdominal pain").The patient was treated with surgery (ablation d and c and total hysterectomy (uterus and cervix removed)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menorrhagia, genital haemorrhage, abdominal pain, dyspareunia, dysmenorrhoea and vaginal haemorrhage had resolved and the depression and anxiety outcome was unknown.The reporter considered abdominal pain, anxiety, depression, dysmenorrhoea, dyspareunia, genital haemorrhage, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: she received treatment for pelvic/abdominal pain, menorrhagia (heavy menstrual bleeding),gen.Abnormal bleeding, she received treatment for psych injury: no diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: essure device was successfully occluded.Total bilateral occlusion.Fallopian tubes were blocked.No filling of the fallopian tubes is identified following essure placement.Ultrasound pelvis - on an unknown date: hypoechoic lesion within the anterior uterine wall.This may represent a uterine leiomyomata.Correlate clinically.If clinically warranted, an mri examination of the pelvis may be helpful.Nabothian cysts within the cervix.Normal appearing ovaries bilaterally.Lot number reported 56349 is not valid quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-sep-2019: pfs received: events abdominal pain, gen.Abnormal bleeding added.No valid lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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
• MDR Report Key: 8861736
• MDR Text Key: 153359863
• Report Number: 2951250-2019-04376
• 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: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2009
• Device Model Number: ESS305
• Device Lot Number: 56349-NOT VALID
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TROPOLONE; TROPOLONE; TROPOLONE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR