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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Insufficient Information (3190)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2008, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (removal of the essure).Essure was removed in 2009.At the time of the report, the device breakage and pelvic pain outcome was unknown.The reporter considered device breakage and pelvic pain to be related to essure.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing/ device breakage") in a female patient who had essure (batch no.6565411) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety.Concurrent conditions included weight gain, ovarian pain, cough, sneezing and post coital bleeding.Concomitant products included ibuprofen and vicodin.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (laparoscopically-assisted vaginal hysterectomy.Vaporization of endometriosis, b/l salpingectomy).Essure was removed on (b)(6) 2010.At the time of the report, the device breakage and pelvic pain outcome was unknown.The reporter considered device breakage and pelvic pain to be related to essure.The reporter commented: discrepancy noted in essure insertion & removal date.Insertion dates: (b)(6) 2009 & 2008.Removal dates: (b)(6) 2100 & 2009.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - (b)(6) 2009: total bilateral occlusion.(b)(6) 2010: surgical pathology report.Diagnosis: uterus, cervix, bilateral fallopian tubes, hysterectomy, bilateral salpingectomy: 1.Cervix: a.Endocervix and ectocervix.B.Negative for dysplasia or malignancy.2.Uterus: a.Secretory endometrium.B.Myometrium.C.Serosa with no diagnostic abnormality.D.Negative for malignancy.3.Fallopian tubes: a.Paratubal cysts, benign.B.Negative for malignancy.Most recent follow-up information incorporated above includes: on 13-jun-2018: plaintiff fact sheet and medical records received.New reporters added and case updated to medically confirm.Patient¿s demographics, concomitant condition, historical condition and concomitant medication added.Essure implant, explant date and indication updated and lot number added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing/ device breakage") in an adult female patient who had essure (batch no.6565411, 646511) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety.Concurrent conditions included weight gain, ovarian pain, cough, sneezing, post coital bleeding, abdominal cramps and paratubal cyst.Concomitant products included ibuprofen and vicodin.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (laparoscopically-assisted vaginal hysterectomy.Vaporization of endometriosis, b/l salpingectomy).Essure was removed on (b)(6) 2010.At the time of the report, the device breakage and pelvic pain outcome was unknown.The reporter considered device breakage and pelvic pain to be related to essure.The reporter commented: discripancy noted in essure insertion & removal date.Four trailing coils on the left and five trailing coils on the right.Insertion dates: (b)(6) 2009 & 2008.Removal dates: (b)(6) 2010 & 2009.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion; on (b)(6) 2009: each micro insert appears to be in a normal spot (b)(6) 2010: surgical pathology report diagnosis: uterus, cervix, bilateral fallopian tubes, hysterectomy, bilateral salpingectomy: 1.Cervix: a.Endocervix and ectocervix.B.Negative for dysplasia or malignancy.2.Uterus: a.Secretory endometrium.B.Myometrium.C.Serosa with no diagnostic abnormality.D.Negative for malignancy.3.Fallopian tubes: a.Paratubal cysts, benign.B.Negative for malignancy.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Most recent follow-up information incorporated above includes: on 25-sep-2018: medical record received.Reporter's information and lot number was added.Concomitant diseases and lab data were added.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing/ device breakage") in an adult female patient who had essure (batch no.6565411, 646511) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety and augmentation mammoplasty.Previously administered products included for birth control: depo provera.Concurrent conditions included weight gain, ovarian pain, cough, sneezing, post coital bleeding, abdominal cramps, paratubal cyst, fibromyalgia and post-traumatic stress disorder.Concomitant products included cetirizine hydrochloride (zyrtec), ibuprofen, ibuprofen (motrin) and vicodin.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea (cramping)") and arthralgia ("hip pain (pain in both of my side)").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), dyspareunia ("dyspareunia (painful sexual intercourse)") and coital bleeding ("bleeding during intercourse").The patient was treated with surgery (laparoscopically-assisted vaginal hysterectomy.Vaporization of endometriosis, b/l salpingectomy).Essure was removed on (b)(6) 2010.At the time of the report, the device breakage, vaginal haemorrhage, menorrhagia, dysmenorrhoea, dyspareunia and coital bleeding outcome was unknown and the pelvic pain and arthralgia had resolved.The reporter considered arthralgia, coital bleeding, device breakage, dysmenorrhoea, dyspareunia, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: discripancy noted in essure insertion & removal date.Four trailing coils on the left and five trailing coils on the right.Insertion dates: (b)(6) 2009 & 2008.Removal dates: (b)(6) 2100 & 2009.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion; on (b)(6) 2009: each micro insert appears to be in a normal spot (b)(6) 2010: surgical pathology report diagnosis: uterus, cervix, bilateral fallopian tubes, hysterectomy, bilateral salpingectomy: cervix: endocervix and ectocervix.Negative for dysplasia or malignancy.Uterus: secretory endometrium.Myometrium.Serosa with no diagnostic abnormality.Negative for malignancy.Fallopian tubes: paratubal cysts, benign.Negative for malignancy.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Most recent follow-up information incorporated above includes: on 26-sep-2018: pfs received.Events:abnormal bleeding (vaginal, menorrhagia), dysmenorrhea (cramping), dyspareunia (painful sexual intercourse),hip pain, coital bleeding were added.Concomitant drugs, concomitant disease, historical drug were aaded.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing/ device breakage") in an adult female patient who had essure (batch no.646511, 6565411-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included anxiety and augmentation mammoplasty.Previously administered products included for birth control: depo provera.Concurrent conditions included weight gain, ovarian pain, cough, sneezing, post coital bleeding, abdominal cramps, paratubal cyst, fibromyalgia and post-traumatic stress disorder.Concomitant products included cetirizine hydrochloride (zyrtec), ibuprofen, ibuprofen (motrin) and vicodin.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea (cramping)") and arthralgia ("hip pain (pain in both of my side)").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), dyspareunia ("dyspareunia (painful sexual intercourse)") and coital bleeding ("bleeding during intercourse").The patient was treated with surgery (laparoscopically-assisted vaginal hysterectomy.Vaporization of endometriosis, b/l salpingectomy).Essure was removed on (b)(6) 2010.At the time of the report, the device breakage, vaginal haemorrhage, menorrhagia, dysmenorrhoea, dyspareunia and coital bleeding outcome was unknown and the pelvic pain and arthralgia had resolved.The reporter considered arthralgia, coital bleeding, device breakage, dysmenorrhoea, dyspareunia, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: discripancy noted in essure insertion & removal date.Four trailing coils on the left and five trailing coils on the right.Insertion dates: (b)(6) 20009 & 2008 removal dates: (b)(6) 2100 & 2009 diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: total bilateral occlusion; on (b)(6) 2009: each micro insert appears to be in a normal spot (b)(6) 2010: surgical pathology report diagnosis: uterus, cervix, bilateral fallopian tubes, hysterectomy, bilateral salpingectomy: 1.Cervix: a.Endocervix and ectocervix.B.Negative for dysplasia or malignancy.2.Uterus: a.Secretory endometrium.B.Myometrium.C.Serosa with no diagnostic abnormality.D.Negative for malignancy.3.Fallopian tubes: a.Paratubal cysts, benign.B.Negative for malignancy.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain lot number:646511 manufacture date: 2009/06 expiration date: 2012/06 lot number 6565411 is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 4-oct-2018: quality-safety evaluation of product technical complaint.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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: 7071118
• MDR Text Key: 93349863
• Report Number: 2951250-2017-09489
• Device Sequence Number: 1
• Product Code: HHS
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2012
• Device Model Number: ESS305
• Device Lot Number: 646511, 6565411-INV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN; IBUPROFEN; IBUPROFEN; IBUPROFEN; MOTRIN; MOTRIN; VICODIN; VICODIN; VICODIN; VICODIN; ZYRTEC; ZYRTEC
• Patient Outcome(s): Other; Required Intervention