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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 ESS205
Device Problems Migration or Expulsion of Device (1395); Separation Failure (2547); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Internal Organ Perforation (1987); Perforation (2001); Heavier Menses (2666); Foreign Body In Patient (2687)
Event Date 03/01/2007
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of perforation ("perforation of organs") and device dislocation ("migration of implant") in a female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.In 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (surgery to remove essure devices).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the perforation, device dislocation and pelvic pain outcome was unknown.The reporter considered device dislocation, pelvic pain and perforation to be related to essure (ess205).Further company follow-up with the lawyer is not possible.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 device expulsion ("migration of implant/ migration of essure device location of device: left coil is in uterus"), perforation ("perforation of organs"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia") and endometriosis ("surgery (other) type of surgery: exploratory surgery for endometriosis") in a 27-year-old female patient who had essure (ess205) (batch no.621688,621808) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "difficulty with deployment" on (b)(6) 2007 and device use issue "device tangled around the essure placement device" on (b)(6) 2007.The patient's medical history included body mass index normal and adhd.Concurrent conditions included rectal pain, endometrium cystic, thalassemia, microcytosis, electrophoresis nos, microcytosis, premenstrual pain, back pain, pain of lower extremities, adnexa uteri mass, ovarian cyst and knee arthropathy.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since 2009 and intrauterine contraceptive device (iud nos).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal hemorrhage)").In (b)(6) 2007, the patient experienced rash ("rashes or skin conditions type: rash on elbow and inner elbow").In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2008, the patient experienced pelvic pain ("pain/ labor like sharp stabbing pains during cycle.Pain so intense fainted while driving") and nausea ("nausea").In (b)(6) 2008, the patient experienced fatigue ("fatigue/ chonic fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: severe bloating") and constipation ("gastrointestinal or digestive system condition type: constipation").In (b)(6) 2008, the patient experienced vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast infection").In (b)(6) 2009, the patient experienced memory impairment ("neurological conditions or problems type: forgetfulness") and amnesia ("neurological conditions or problems type: short term memory loss,").In (b)(6) 2012, the patient experienced anxiety ("psychological or psychiatric problems condition: anxiety") and depression ("psychological or psychiatric problems condition: anxiety/depression").In (b)(6) 2013, the patient experienced vision blurred ("vision/eye problems type: blurred vision").In (b)(6) 2015, the patient experienced alopecia ("hair loss").On (b)(6) 2016, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), endometriosis (seriousness criterion medically significant), confusional state ("neurological conditions or problems type: confusion"), tinnitus ("neurological conditions or problems type ringing in ears"), syncope ("fainting/ pain so intense fainted while driving"), allergy to metals ("nickel allergy"), back pain ("back pain"), pain in extremity ("leg pain/thigh pain") and abdominal pain ("abdomen pain").The patient was treated with surgery (b)(6) 2007-ablation, d and c, (b)(6) 2017-exploratory surgery, laparoscopic left salpingectomy with laparoscopic left ovarian cystectomy, unilateral salpingo-oopho and laparoscopic left salpingectomy with laparoscopic left ovarian cystectomy.).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the device expulsion, perforation, menorrhagia, endometriosis, pelvic pain, vaginal haemorrhage, vulvovaginal mycotic infection, anxiety, depression, rash, nausea, confusional state, memory impairment, amnesia, tinnitus, syncope, dysmenorrhoea, fatigue, vision blurred, abdominal distension, constipation, alopecia, back pain, pain in extremity and abdominal pain outcome was unknown and the allergy to metals had not resolved.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, amnesia, anxiety, back pain, confusional state, constipation, depression, device expulsion, dysmenorrhoea, endometriosis, fatigue, memory impairment, menorrhagia, nausea, pain in extremity, pelvic pain, perforation, rash, syncope, tinnitus, vaginal haemorrhage, vision blurred and vulvovaginal mycotic infection to be related to essure (ess205).The reporter commented: date of insertion: (b)(6) 2006,(b)(6) 2007.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Ultrasound scan - on (b)(6) 2007: total bilateral occlusion.Lot number: 621688, manufacturing date: 2006-11, expiration date: 2008-10.Lot number: 621808, manufacturing date: 2006-12, expiration date: 2008-11.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 20-may-2019: quality safety evaluation of product technical compliant 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-conformances 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 device expulsion ("migration of implant/ migration of essure device location of device: left coil is in uterus"), perforation ("perforation of organs"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia") and endometriosis ("surgery (other) type of surgery: exploratory surgery for endometriosis") in a 27-year-old female patient who had essure (ess205) (batch no.621688,621808) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "difficulty with deployment" on (b)(6) 2007 and device use issue "device tangled around the essure placement device" on (b)(6) 2007.The patient's medical history included body mass index normal and adhd.Concurrent conditions included rectal pain, endometrium cystic, thalassemia, microcytosis, electrophoresis, microcytosis, premenstrual pain, back pain, pain of lower extremities, adnexa uteri mass, ovarian cyst and knee arthropathy.Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (adderall) since 2009 and intrauterine contraceptive device (iud nos).On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required) and vaginal haemorrhage ("abnormal bleeding (vaginal hemorrhage)").In (b)(6) 2007, the patient experienced rash ("rashes or skin conditions type: rash on elbow and inner elbow").In (b)(6) 2007, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2008, the patient experienced pelvic pain ("pain/ labor like sharp stabbing pains during cycle.Pain so intense fainted while driving") and nausea ("nausea").In (b)(6) 2008, the patient experienced fatigue ("fatigue/ chronic fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: severe bloating") and constipation ("gastrointestinal or digestive system condition type: constipation").In (b)(6) 2008, the patient experienced vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: yeast infection").In (b)(6) 2009, the patient experienced memory impairment ("neurological conditions or problems type: forgetfulness") and amnesia ("neurological conditions or problems type: short term memory loss,").In (b)(6) 2012, the patient experienced anxiety ("psychological or psychiatric problems condition: anxiety") and depression ("psychological or psychiatric problems condition: anxiety/depression").In (b)(6) 2013, the patient experienced vision blurred ("vision/eye problems type: blurred vision").In (b)(6) 2015, the patient experienced alopecia ("hair loss").On (b)(6) 2016, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), endometriosis (seriousness criterion medically significant), confusional state ("neurological conditions or problems type: confusion"), tinnitus ("neurological conditions or problems type ringing in ears"), syncope ("fainting/ pain so intense fainted while driving"), allergy to metals ("nickel allergy"), back pain ("back pain"), pain in extremity ("leg pain/thigh pain") and abdominal pain ("abdomen pain").The patient was treated with surgery ((b)(6) 2007-ablation, d and c, (b)(6) 2017-exploratory surgery, laparoscopic left salpingectomy with laparoscopic left ovarian cystectomy, unilateral salpingo-oopho and laparoscopic left salpingectomy with laparoscopic left ovarian cystectomy.).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the device expulsion, perforation, menorrhagia, endometriosis, pelvic pain, vaginal haemorrhage, vulvovaginal mycotic infection, anxiety, depression, rash, nausea, confusional state, memory impairment, amnesia, tinnitus, syncope, dysmenorrhoea, fatigue, vision blurred, abdominal distension, constipation, alopecia, back pain, pain in extremity and abdominal pain outcome was unknown and the allergy to metals had not resolved.The reporter considered abdominal distension, abdominal pain, allergy to metals, alopecia, amnesia, anxiety, back pain, confusional state, constipation, depression, device expulsion, dysmenorrhoea, endometriosis, fatigue, memory impairment, menorrhagia, nausea, pain in extremity, pelvic pain, perforation, rash, syncope, tinnitus, vaginal haemorrhage, vision blurred and vulvovaginal mycotic infection to be related to essure (ess205).The reporter commented: date of insertion: (b)(6) 2006, (b)(6) 2007.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.3 kg/sqm.Ultrasound scan - on (b)(6) 2007: total bilateral occlusion.Further company follow-up with the lawyer is not possible.Most recent follow-up information incorporated above includes: on 10-may-2019: pfs and mr received reporter information was added.Lot no and product indication was added.New event was added.Vaginal hemorrhage, menorrhagia, yeast infection, anxiety,depression, rash , device expulsion, nausea, confusion, forgetfulness, short term memory loss, ringing in ears, fainting, nickel allergy, dysmenorrhea, endometriosis, fatigue, blurred vision, bloating, constipation, hair loss, labor pain and event onset date added.Updated event device dislocation to device expulsion.Severity was added pelvic pain.Concomitant drug was added.Medical history was added.Lab test was 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-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary 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 Key7429417
MDR Text Key105429104
Report Number2951250-2018-01783
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 05/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2008
Device Model NumberESS205
Device Lot Number621688,621808
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADDERALL.; ADDERALL.; IUD NOS.; IUD NOS.
Patient Outcome(s) Other; Required Intervention;
Patient Age27 YR
Patient Weight66
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