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

Model Number ESS305

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ectopic Pregnancy (1819); Headache (1880); Pain (1994); Abnormal Vaginal Discharge (2123); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of back pain ("severe back pain") and genital haemorrhage ("abnormal, heavy bleeding") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), migraine ("migraines"), vaginal discharge ("irregular vaginal discharge") and procedural pain ("painful post-operative recovery").The patient was treated with surgery (underwent a bilateral salpingectomy to remove the essure device).Essure was removed on (b)(6) 2015.At the time of the report, the back pain, genital haemorrhage, migraine, vaginal discharge and procedural pain was resolving.The reporter considered back pain, genital haemorrhage, migraine, procedural pain and vaginal discharge to be related to essure.The reporter commented: following the surgery, plaintiff suffered a painful post-operative recovery.Since having the surgery, plaintiff symptoms are mostly resolved.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: confirming full occlusion of fallopian tubes.Incident.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 back pain ("severe back pain"), genital haemorrhage ("abnormal, heavy bleeding"), systemic lupus erythematosus ("lupus"), autoimmune disorder ("autoimmune"), cerebrovascular accident ("stroke/ hemorrhagic stroke occipital stroke due to lupus"), haemorrhagic stroke ("hemorrhagic stroke occipital stroke due to lupus") and gallbladder operation ("gall bladder surgery") in a 37-year-old female patient who had essure (batch no.789037) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included hellp syndrome and cerebrovascular accident.Previously administered products included for an unreported indication: aspirin.Concurrent conditions included abdominal pain, vomiting, nausea, anemia, thrombocytopenia, hematuria, subcortical vasogenic edema, partial visual loss and herpes zoster.Concomitant products included mycophenolate mofetil from (b)(6) 2014 to (b)(6) 2017, prednisolone from (b)(6) 2014 to (b)(6) 2015 and rituximab from (b)(6) 2014.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2014, 3 years 6 months after insertion of essure, the patient experienced cerebrovascular accident (seriousness criterion medically significant), haemorrhagic stroke (seriousness criterion medically significant) and gallbladder operation (seriousness criterion medically significant).On (b)(6) 2014, the patient underwent cerebrovascular accident (seriousness criterion medically significant), haemorrhagic stroke (seriousness criterion medically significant) and gallbladder operation (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced nausea ("nausea") and pelvic pain ("pain").On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), migraine ("migraines"), vaginal discharge ("irregular vaginal discharge"), procedural pain ("painful post-operative recovery"), systemic lupus erythematosus (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant) and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (underwent a bilateral salpingectoniy to remove the essure device).Essure was removed on (b)(6) 2015.At the time of the report, the back pain, genital haemorrhage, migraine, vaginal discharge and procedural pain was resolving, the systemic lupus erythematosus, nausea, pelvic pain, cerebrovascular accident, haemorrhagic stroke, abdominal pain upper and gallbladder operation outcome was unknown and the autoimmune disorder had not resolved.The reporter considered abdominal pain upper, autoimmune disorder, back pain, cerebrovascular accident, gallbladder operation, genital haemorrhage, haemorrhagic stroke, migraine, nausea, pelvic pain, procedural pain, systemic lupus erythematosus and vaginal discharge to be related to essure.The reporter commented: following the surgery, plaintiff suffered a painful post-operative recovery.Since having the surgery, plaintiff symptoms are mostly resolved.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: confirming full occlusion of fallopian tubes on (b)(6) 2011, she had dye test resulted tubes blocked.Most recent follow-up information incorporated above includes: on 25-may-2018: reporters added and updated patient demographics.Historical drug, historical condition, concomitant drugs were added.Updated suspect drug inaction and lot number.Added events allergic or hypersensitivity reaction type: autoimmune, autoimmune disorder type of disorder: lupus, nausea,pain, vision/eye problems type: occipital lobe stroke, stroke, upper abdominal pain and gall bladder surgery.Updated events, onset dates and outcomes.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 back pain ("severe back pain"), genital haemorrhage ("abnormal, heavy bleeding"), systemic lupus erythematosus ("autoimmune disorder type of disorder: lupus (allergic or hypersensitivity reaction)"), autoimmune disorder ("autoimmune"), cerebrovascular accident ("stroke/ hemorrhagic stroke occipital stroke due to lupus/other injury or complication describe: stroke"), haemorrhagic stroke ("hemorrhagic stroke occipital stroke due to lupus") and gallbladder operation ("gall bladder surgery") in a 37-year-old female patient who had essure (batch no.789037) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included hellp syndrome and cerebrovascular accident.Previously administered products included for an unreported indication: aspirin.Concurrent conditions included abdominal pain, vomiting, nausea, anemia, thrombocytopenia, hematuria, subcortical vasogenic edema, partial visual loss and herpes zoster.Concomitant products included mycophenolate mofetil from (b)(6) 2014 to (b)(6) 2017, prednisolone from (b)(6) 2014 to (b)(6) 2015 and rituximab from (b)(6) 2014 to (b)(6) 2014.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2014, 3 years 6 months after insertion of essure, the patient underwent gallbladder operation (seriousness criterion medically significant).On (b)(6) 2014, the patient experienced haemorrhagic stroke (seriousness criterion medically significant), nausea ("nausea") and pelvic pain ("pain").On an unknown date, the patient experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), systemic lupus erythematosus (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), cerebrovascular accident (seriousness criterion medically significant), migraine ("migraines"), vaginal discharge ("irregular vaginal discharge"), procedural pain ("painful post-operative recovery") and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (underwent a bilateral salpingectoniy to remove the essure device).Essure was removed on (b)(6) 2015.At the time of the report, the back pain, genital haemorrhage, migraine, vaginal discharge and procedural pain was resolving, the systemic lupus erythematosus, cerebrovascular accident, haemorrhagic stroke, gallbladder operation, nausea, pelvic pain and abdominal pain upper outcome was unknown and the autoimmune disorder had not resolved.The reporter considered abdominal pain upper, autoimmune disorder, back pain, cerebrovascular accident, gallbladder operation, genital haemorrhage, haemorrhagic stroke, migraine, nausea, pelvic pain, procedural pain, systemic lupus erythematosus and vaginal discharge to be related to essure.The reporter commented: following the surgery, plaintiff suffered a painful post-operative recovery.Since having the surgery, plaintiff symptoms are mostly resolved.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: confirming full occlusion of fallopian tubes on jul-2011, she had dye test resuletd tubes blocked.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-aug-2018: quality-safety evaluation of ptc.On 26-jul-2018: no new clinical information received.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

This spontaneous case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ('ectopic pregnancy') and back pain ('severe back pain') in a 37-year-old female patient who had essure (batch no.789037) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included hellp syndrome and cerebrovascular accident.*on(b)(6)2011, she had dye test resuleted tubes blocked.Previously administered products included for an unreported indication: aspirin.Concurrent conditions included abdominal pain, vomiting, nausea, anemia, thrombocytopenia, hematuria, subcortical vasogenic edema, partial visual loss, herpes zoster and systemic lupus erythematosus.Concomitant products included intrauterine contraceptive device (paragard) from 2007 to 2011, mycophenolate mofetil from (b)(6) 2014 to (b)(6) 2017, prednisolone from(b)(6)2014 to (b)(6) 2015 and rituximab from (b)(6) 2014 to (b)(6)2014.On (b)(6)2011, the patient had essure inserted.On (b)(6)2014, the patient underwent gallbladder operation ("gall bladder surgery"), 3 years 6 months after insertion of essure.On (b)(6)2014, the patient experienced haemorrhagic stroke ("hemorrhagic stroke occipital stroke due to lupus"), nausea ("nausea") and pelvic pain ("pain").On an unknown date, the patient was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required) and experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal, heavy bleeding"), systemic lupus erythematosus ("autoimmune disorder type of disorder: lupus (allergic or hypersensitivity reaction)"), autoimmune disorder ("autoimmune"), cerebrovascular accident ("stroke/ hemorrhagic stroke occipital stroke due to lupus/other injury or complication describe: stroke"), migraine ("migraines"), vaginal discharge ("irregular vaginal discharge"), procedural pain ("painful post-operative recovery") and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (essure removal and underwent a bilateral salpingectoniy to remove the essure device).Essure was removed on (b)(6)2015.At the time of the report, the ectopic pregnancy with contraceptive device, systemic lupus erythematosus, cerebrovascular accident, haemorrhagic stroke, gallbladder operation, nausea, pelvic pain and abdominal pain upper outcome was unknown, the back pain, genital haemorrhage, migraine, vaginal discharge and procedural pain was resolving and the autoimmune disorder had not resolved.The reporter considered abdominal pain upper, autoimmune disorder, back pain, cerebrovascular accident, ectopic pregnancy with contraceptive device, gallbladder operation, genital haemorrhage, haemorrhagic stroke, migraine, nausea, pelvic pain, procedural pain, systemic lupus erythematosus and vaginal discharge to be related to essure.The reporter commented: following the surgery, plaintiff suffered a painful post-operative recovery.Since having the surgery, plaintiff symptoms are mostly resolved.Discrepancy noted in date(s) of removal: (b)(6)2015 and (b)(6)2015.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6)2011: results: confirming full occlusion of fallopian tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6)2020: pif received: events: ectopic pregnancy and device ineffective were added.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 reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ('ectopic pregnancy') and back pain ('severe back pain') in a 37-year-old female patient who had essure (batch no.789037) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's medical history included hellp syndrome and cerebrovascular accident.*on (b)(6) 2011, she had dye test resuleted tubes blocked.Previously administered products included for an unreported indication: aspirin.Concurrent conditions included abdominal pain, vomiting, nausea, anemia, thrombocytopenia, hematuria, subcortical vasogenic edema, partial visual loss, herpes zoster and systemic lupus erythematosus.Concomitant products included intrauterine contraceptive device (paragard) from 2007 to 2011, mycophenolate mofetil from (b)(6) 2014 to (b)(6) 2017, prednisolone from november 2014 to march 2015 and rituximab from (b)(6) 2014.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2014, the patient underwent gallbladder operation ("gall bladder surgery"), 3 years 6 months after insertion of essure.On (b)(6) 2014, the patient experienced haemorrhagic stroke ("hemorrhagic stroke occipital stroke due to lupus"), nausea ("nausea") and pelvic pain ("pain").On an unknown date, the patient was found to have an ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required) and experienced back pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal, heavy bleeding"), systemic lupus erythematosus ("autoimmune disorder type of disorder: lupus (allergic or hypersensitivity reaction)"), autoimmune disorder ("autoimmune"), cerebrovascular accident ("stroke/ hemorrhagic stroke occipital stroke due to lupus/other injury or complication describe: stroke"), migraine ("migraines"), vaginal discharge ("irregular vaginal discharge"), procedural pain ("painful post-operative recovery") and abdominal pain upper ("upper abdominal pain").The patient was treated with surgery (essure removal and underwent a bilateral salpingectoniy to remove the essure device).Essure was removed on (b)(6) 2015.At the time of the report, the ectopic pregnancy with contraceptive device, systemic lupus erythematosus, cerebrovascular accident, haemorrhagic stroke, gallbladder operation, nausea, pelvic pain and abdominal pain upper outcome was unknown, the back pain, genital haemorrhage, migraine, vaginal discharge and procedural pain was resolving and the autoimmune disorder had not resolved.The reporter considered abdominal pain upper, autoimmune disorder, back pain, cerebrovascular accident, ectopic pregnancy with contraceptive device, gallbladder operation, genital haemorrhage, haemorrhagic stroke, migraine, nausea, pelvic pain, procedural pain, systemic lupus erythematosus and vaginal discharge to be related to essure.The reporter commented: following the surgery, plaintiff suffered a painful post-operative recovery.Since having the surgery, plaintiff symptoms are mostly resolved.Discrepancy noted in date(s) of removal: (b)(6) 2015 and (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: results: confirming full occlusion of fallopian tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-jun-2020: pif received: events: ectopic pregnancy and device ineffective were added.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
• MDR Report Key: 6961217
• MDR Text Key: 89708854
• Report Number: 2951250-2017-05107
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2013
• Device Model Number: ESS305
• Device Lot Number: 789037
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MYCOPHENOLATE MOFETIL.; MYCOPHENOLATE MOFETIL.; MYCOPHENOLATE MOFETIL.; MYCOPHENOLATE MOFETIL.; PARAGARD.; PARAGARD.; PREDNISOLONE.; PREDNISOLONE.; PREDNISOLONE.; PREDNISOLONE.; RITUXIMAB.; RITUXIMAB.; RITUXIMAB.; RITUXIMAB.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR