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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Ectopic Pregnancy (1819); Gastritis (1874); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Menstrual Irregularities (1959); Pain (1994); Abnormal Vaginal Discharge (2123); Myalgia (2238); Discomfort (2330); Arthralgia (2355); Weight Changes (2607); Foreign Body In Patient (2687); No Code Available (3191); Pregnancy (3193)
Event Date 01/01/2017
Event Type  Injury  
Event Description
This retrospective pregnancy case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ("pregnancy (ectopic)") and device dislocation ("migration of essure device: left fallopian tube") in a (b)(6) female patient who had essure (batch no.740654) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test".The patient's past medical history included multigravida and parity 2.Previously administered products included for an unreported indication: azithromycin and depo provera.Concurrent conditions included obesity.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced back pain ("back pain").In 2011, the patient experienced pelvic pain ("pelvic pain and cramping/ pain/ severe pelvic pain"), abdominal pain ("abdominal pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)"), gastritis ("gastrointestinal /digestive system condition: acute gastritis without hemorrhage"), abdominal pain lower ("cramping"), arthralgia ("joint pain"), myalgia ("muscle pain") and pain in extremity ("pain in both legs, cannot stand too long").In (b)(6) 2011, the patient experienced migraine ("migraines"), weight fluctuation ("weight fluctuations"), weight increased ("weight gain/loss: weight gain") and headache ("headaches").On (b)(6) 2013, 2 years 9 months after insertion of essure, the patient experienced vaginal infection ("vaginal infection / vaginitis") with vaginal discharge and vulvovaginitis ("vulvovaginitis").In 2017, the patient experienced ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required).On (b)(6) 2018, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced musculoskeletal pain ("joint and muscle pain"), tooth disorder ("dental problems"), epigastric discomfort ("epigastric discomfort") and smear cervix abnormal ("other: abnormal pap smear").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with surgery ((b)(6) 2018: unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy) and surgery ((b)(6) 2018: unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy).At the time of the report, the ectopic pregnancy with contraceptive device, device dislocation, menorrhagia, vaginal haemorrhage, dysmenorrhoea, weight increased, gastritis, vulvovaginitis, abdominal pain lower, arthralgia, myalgia, pain in extremity, headache and smear cervix abnormal outcome was unknown and the pelvic pain, abdominal pain, back pain, musculoskeletal pain, migraine, tooth disorder, vaginal infection and weight fluctuation had not resolved.The reporter considered abdominal pain, abdominal pain lower, arthralgia, back pain, device dislocation, dysmenorrhoea, ectopic pregnancy with contraceptive device, gastritis, headache, menorrhagia, migraine, musculoskeletal pain, myalgia, pain in extremity, pelvic pain, tooth disorder, vaginal haemorrhage, vaginal infection, vulvovaginitis, weight fluctuation and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: it was reported that right ostium visualized, essure deployed with 2 trailing coils.Left ostium visualized, essure deployed with 3 trailing coils.She also had abnormal pap smear.Unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy done.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(4).Most recent follow-up information incorporated above includes: on 2-mar-2018: pfs received.Reporters added and updated patient demographics.Historical condition, historical drug and concomitant diseases were added.Updated suspect drug indication and lot number.Added events abnormal bleeding (vaginal, menorrhagia), dysmenorrhea, gastrointestinal /digestive system condition: acute gastritis without hemorrhage, infection: vaginitis, vulvovaginitis, headaches, migration of essure device: left fallopian tube, pregnancy (ectopic), vaginal discharge, weight gain/loss: weight gain, pain in both legs, cannot stand too long.Cramping, joint and muscle pain.Updated events and onset dates.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
Prospective pregnancy case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ("pregnancy (ectopic)") and device dislocation ("migration of essure device: left fallopian tube") in a 32-year-old female patient who had essure (batch no.740654) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test".The patient's past medical history included multigravida and parity 2.Previously administered products included for an unreported indication: azithromycin and depo provera.Concurrent conditions included obesity.Concomitant products included ceftriaxone (rocephin), cheracol (robitussin ac [codeine phosphate,guaifenesin]), famotidine (mylanta ar), famotidine (pepcid), ibuprofen (motrin) since (b)(6) 2010 and paracetamol (tylenol).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced back pain ("back pain").In 2011, the patient experienced pelvic pain ("pelvic pain and cramping/ pain/ severe pelvic pain"), abdominal pain ("abdominal pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), gastritis ("gastrointestinal /digestive system condition: acute gastritis without hemorrhage"), abdominal pain lower ("cramping"), arthralgia ("joint pain"), myalgia ("muscle pain") and pain in extremity ("pain in both legs, cannot stand too long").In (b)(6) 2011, the patient experienced migraine ("migraines"), weight fluctuation ("weight fluctuations"), weight increased ("weight gain/loss: weight gain") and headache ("headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, 2 years 9 months after insertion of essure, the patient experienced vaginal infection ("vaginal infection / vaginitis") with vaginal discharge and vulvovaginitis ("vulvovaginitis").In 2017, the patient experienced ectopic pregnancy with contraceptive device (seriousness criteria hospitalization and intervention required).On (b)(6) 2018, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced musculoskeletal pain ("joint and muscle pain"), tooth disorder ("dental problems"), epigastric discomfort ("epigatric discomfort") and smear cervix abnormal ("other: abnormal pap smear").Last menstrual period and estimated date of delivery were not provided.The patient had essure in place during the first trimester of pregnancy.The patient was treated with azithromycin, metronidazole (flagyl), fluconazole (diflucan), meloxicam, surgery ((b)(6) 2018: unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy).Essure was removed on (b)(6) 2018.At the time of the report, the ectopic pregnancy with contraceptive device, device dislocation, menorrhagia, vaginal haemorrhage, dysmenorrhoea, weight increased, gastritis, vulvovaginitis, abdominal pain lower, arthralgia, myalgia, pain in extremity, headache and smear cervix abnormal outcome was unknown and the pelvic pain, abdominal pain, back pain, musculoskeletal pain, migraine, tooth disorder, vaginal infection and weight fluctuation had not resolved.The reporter considered abdominal pain, abdominal pain lower, arthralgia, back pain, device dislocation, dysmenorrhoea, ectopic pregnancy with contraceptive device, epigastric discomfort, gastritis, headache, menorrhagia, migraine, musculoskeletal pain, myalgia, pain in extremity, pelvic pain, smear cervix abnormal, tooth disorder, vaginal haemorrhage, vaginal infection, vulvovaginitis, weight fluctuation and weight increased to be related to essure.The reporter commented: it was reported that right ostium visualized, essure deployed with 2 trailing coils.Left ostium visualized, essure deployed with 3 trailing coils.She also had abnormal pap smear.Unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy done.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.8 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-aug-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.
 
Manufacturer Narrative
Rospective pregnancy case was reported by a lawyer and describes the occurrence of ectopic pregnancy with contraceptive device ("pregnancy (ectopic)") and device dislocation ("migration of essure device: left fallopian tube") in a 32-year-old female patient who had essure (batch no.740654) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test".The patient's past medical history included multigravida and parity 2.Previously administered products included for an unreported indication: azithromycin and depo provera.Concurrent conditions included obesity.Concomitant products included ceftriaxone (rocephin), cheracol (robitussin ac [codeine phosphate,guaifenesin]), famotidine (mylanta ar), famotidine (pepcid), ibuprofen (motrin) since (b)(6) 2010 and paracetamol (acetaminophen).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2011, the patient experienced back pain ("back pain").In 2011, the patient experienced pelvic pain ("pelvic pain and cramping/ pain/ severe pelvic pain"), abdominal pain ("abdominal pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), gastritis ("gastrointestinal /digestive system condition: acute gastritis without hemorrhage"), abdominal pain lower ("cramping"), arthralgia ("joint pain"), myalgia ("muscle pain") and pain in extremity ("pain in both legs, cannot stand too long").In (b)(6) 2011, the patient experienced migraine ("migraines"), weight fluctuation ("weight fluctuations"), weight increased ("weight gain/loss: weight gain") and headache ("headaches").In (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, 2 years 9 months after insertion of essure, the patient experienced vaginal infection ("vaginal infection / vaginitis") with vaginal discharge and vulvovaginitis ("vulvovaginitis").In 2017, the patient experienced ectopic pregnancy with contraceptive device (seriousness criteria hospitalization and intervention required).On (b)(6) 2018, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced musculoskeletal pain ("joint and muscle pain"), tooth disorder ("dental problems"), epigastric discomfort ("epigatric discomfort") and smear cervix abnormal ("other: abnormal pap smear").Last menstrual period and estimated date of delivery were not provided.The patient had essure during the first trimester of pregnancy.The patient was treated with azithromycin, metronidazole (flagyl), fluconazole (diflucan), meloxicam, surgery ((b)(6) 2018: unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy) and surgery ((b)(6) 2018: unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy).At the time of the report, the ectopic pregnancy with contraceptive device, device dislocation, menorrhagia, vaginal haemorrhage, dysmenorrhoea, weight increased, gastritis, vulvovaginitis, abdominal pain lower, arthralgia, myalgia, pain in extremity, headache and smear cervix abnormal outcome was unknown and the pelvic pain, abdominal pain, back pain, musculoskeletal pain, migraine, tooth disorder, vaginal infection and weight fluctuation had not resolved.The reporter considered abdominal pain, abdominal pain lower, arthralgia, back pain, device dislocation, dysmenorrhoea, ectopic pregnancy with contraceptive device, epigastric discomfort, gastritis, headache, menorrhagia, migraine, musculoskeletal pain, myalgia, pain in extremity, pelvic pain, smear cervix abnormal, tooth disorder, vaginal haemorrhage, vaginal infection, vulvovaginitis, weight fluctuation and weight increased to be related to essure.The reporter commented: it was reported that right ostium visualized, essure deployed with 2 trailing coils.Left ostium visualized, essure deployed with 3 trailing coils.She also had abnormal pap smear.Unilateral salpingectomy -removal of right fallopian tube, removal of ectopic pregnancy done.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 31.8 kg/sqm.Most recent follow-up information incorporated above includes: on 18-jun-2018: pfs received: treatment and concomitant medications added and seriousness criteria updated to hospitalization for the event ectopic pregnancy with contraceptive device.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.
 
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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 Key7519849
MDR Text Key108497164
Report Number2951250-2018-02190
Device Sequence Number1
Product Code HHS
Combination Product (y/n)N
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/01/2013
Device Model NumberESS305
Device Lot Number740654
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/02/2018
Initial Date FDA Received05/16/2018
Supplement Dates Manufacturer Received06/18/2018
08/03/2018
Supplement Dates FDA Received07/13/2018
08/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MOTRIN; MOTRIN; MYLANTA AR; MYLANTA AR; PEPCID; PEPCID; ROBITUSSIN AC [CODEINE PHOSPHATE,GUAIFENESIN]; ROBITUSSIN AC [CODEINE PHOSPHATE,GUAIFENESIN]; ROCEPHIN; ROCEPHIN; TYLENOL [PARACETAMOL]; TYLENOL [PARACETAMOL]
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age32 YR
Patient Weight89
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