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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); Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Pain (1994); Uterine Perforation (2121)
Event Date 08/15/2012
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration and perforation of the right essure device") in a female patient who had essure inserted for female sterilization.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain.The patient was treated with surgery (underwent total laparoscopic hysterectomy).At the time of the report, the uterine perforation outcome was unknown.The reporter considered uterine perforation to be related to essure.The reporter commented: plaintiff underwent total laparoscopic hysterectomy due to complications from the essure device diagnostic results: (b)(6) 2012: hysterosalpingogram - essure device was successfully occluded on the left side.Company causality comment.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 uterine perforation ("migration and perforation of the right essure device / migration of essure device /perforation (uterus)") and fallopian tube perforation ("perforation (fallopian tube)") in a (b)(6) year-old female patient who had essure (batch no.869763) inserted for female sterilization.The patient's past medical history included gravida ii, parity 2 (((b)(6) 2012, (b)(6) 2010)), flu vaccination in (b)(6) 2010, cholecystectomy, cholecystectomy, pelvic operation in 2004 and perineoplasty.Concurrent conditions included overweight, tobacco user and chronic cervicitis.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 4 months 25 days after insertion and 5 days after removal of essure, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and fallopian tube perforation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (total laparoscopic hysterectomy, a left salpingectomy, and a cystoscopy) and surgery (total hysterectomy).Essure was removed on (b)(6) 2012.At the time of the report, the uterine perforation and fallopian tube perforation outcome was unknown.The reporter considered fallopian tube perforation and uterine perforation to be related to essure.The reporter commented: plaintiff underwent total laparoscopic hysterectomy due to complications from the essure device.At this point, an essure coil was placed in the right fallopian tube.After deployment, there were 3 coils visible.Attention was then turned to the patient's left fallopian tube ostia again, a second essure coil was placed here with 1 coil visualized after deployment.Her uterus was inspected and an essure coil was seen coming out posteriorly to the right isthmus of the fallopian tube.She claimed that the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.4 kg/sqm.(b)(6) 2012: hysterosalpingogram - essure device was successfully occluded on the left side.Failure to occlude (close) fallopian tubes, migration of essure device.Concerning the injuries reported in this case, the following one/ones, events uterine perforation, fallopian tube perforation and pelvic pain were confirmed by the medical records.Most recent follow-up information incorporated above includes: on 26-feb-2018: pfs received - new event "perforation (fallopian tube)" was added.Lot number was added.Product implant and explant date was updated.New reporter were added.Historical and concomitant conditions 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 uterine perforation ("migration and perforation of the right essure device / migration of essure device /perforation (uterus)") and fallopian tube perforation ("perforation (fallopian tube)") in a 26-year-old female patient who had essure (batch no.869763) inserted for female sterilization.The patient's past medical history included gravida ii, parity 2 (((b)(6) 2012, (b)(6) 2010)), flu vaccination in october 2010, cholecystectomy, cholecystectomy, pelvic operation in 2004 and perineoplasty.Concurrent conditions included overweight, ex-tobacco user and chronic cervicitis.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 4 months 25 days after insertion and 5 days after removal of essure, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and fallopian tube perforation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (total laparoscopic hysterectomy, a left salpingectomy, and a cystoscopy) and surgery (total hysterectomy).Essure was removed on (b)(6) 2012.At the time of the report, the uterine perforation and fallopian tube perforation outcome was unknown.The reporter considered fallopian tube perforation and uterine perforation to be related to essure.The reporter commented: plaintiff underwent total laparoscopic hysterectomy due to complications from the essure device.At this point, an essure coil was placed in the right fallopian tube.After deployment, there were 3 coils visible.Attention was then turned to the patient's left fallopian tube ostia again, a second essure coil was placed here with 1 coil visualized after deployment.Her uterus was inspected and an essure coil was seen coming out posteriorly to the right isthmus of the fallopian tube.She claimed that the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.4 kg/sqm.(b)(6) 2012: hysterosalpingogram - essure device was successfully occluded on the left side.Failure to occlude (close) fallopian tubes, migration of essure device.Concerning the injuries reported in this case, the following one/ones, events uterine perforation, fallopian tube perforation and pelvic pain were confirmed by the medicla records.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of ptc.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 uterine perforation ("migration and perforation of the right essure device / migration of essure device /perforation (uterus)") and fallopian tube perforation ("perforation (fallopian tube)") in a 26-year-old female patient who had essure (batch no: 869763) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, parity 2 (on (b)(6) 2012, on (b)(6) 2010), flu vaccination on (b)(6) 2010, cholecystectomy, cholecystectomy, pelvic operation in 2004 and perineoplasty.Concurrent conditions included overweight, ex-tobacco user and chronic cervicitis.Concomitant products included paracetamol (acetaminophen).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 4 months 25 days after insertion and 5 days after removal of essure, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced depression ("depression") and anxiety ("mental anguish").The patient was treated with surgery (total laparoscopic hysterectomy, a left salpingectomy, and a cystoscopy) and surgery (total hysterectomy).Essure was removed on (b)(6) 2012.At the time of the report, the uterine perforation, fallopian tube perforation, depression and anxiety outcome was unknown.The reporter considered anxiety, depression, fallopian tube perforation and uterine perforation to be related to essure.The reporter commented: plaintiff underwent total laparoscopic hysterectomy due to complications from the essure device.At this point, an essure coil was placed in the right fallopian tube.After deployment, there were 3 coils visible.Attention was then turned to the patient's left fallopian tube ostia again, a second essure coil was placed here with 1 coil visualized after deployment.Her uterus was inspected and an essure coil was seen coming out posteriorly to the right isthmus of the fallopian tube.She claimed that the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.4 kg/sqm.On (b)(6) 2012: hysterosalpingogram: essure device was successfully occluded on the left side.Failure to occlude (close) fallopian tubes, migration of essure device.Concerning the injuries reported in this case, the following one/ones, events uterine perforation, fallopian tube perforation and pelvic pain were confirmed by the "medical" records.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-aug-2018: pfs received.Events: depression and mental anguish were added.Concomitant disease 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
This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('migration and perforation of the right essure device / migration of essure device /perforation (uterus)/ failure to occlude (close) fallopian tubes') and fallopian tube perforation ('perforation (fallopian tube)/migration of essure device location of device : right isthmus of the fallopian tube') in a 26-year-old female patient who had essure (batch no.869763) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included flu vaccination in (b)(6) 2010, pelvic operation in 2004, gravida ii, parity 2 (b)(6) 2012, (b)(6) 2010, cholecystectomy, cholecystectomy and perineoplasty.Concurrent conditions included overweight, ex-tobacco user and chronic cervicitis.Concomitant products included drospirenone;ethinylestradiol (gianvi), norethisterone (micronor) and paracetamol (acetaminophen).On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced depression ("depression") and anxiety ("mental anguish"), 4 months 11 days after insertion of essure.On (b)(6) 2012, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and fallopian tube perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced pelvic pain ("chronic pelvic pain / pelvic pain daily, severe"), genital haemorrhage ("gen abnormal bleeding"), psychological trauma ("psych injury") and post procedural complication ("post removal complications").The patient was treated with surgery (total hysterectomy and total laparoscopic hysterectomy, a left salpingectomy, and a cystoscopy).Essure was removed on (b)(6) 2012.At the time of the report, the uterine perforation, pelvic pain and genital haemorrhage had resolved and the fallopian tube perforation, depression, anxiety, psychological trauma and post procedural complication outcome was unknown.The reporter considered anxiety, depression, fallopian tube perforation, genital haemorrhage, post procedural complication, psychological trauma and uterine perforation to be related to essure.No further causality assessment were provided for the product.The reporter commented: plaintiff underwent total laparoscopic hysterectomy due to complications from the essure device.At this point, an essure coil was placed in the right fallopian tube.After deployment, there were 3 coils visible.Attention was then turned to the patient's left fallopian tube ostia again, a second essure coil was placed here with 1 coil visualized after deployment.Her uterus was inspected and an essure coil was seen coming out posteriorly to the right isthmus of the fallopian tube.She claimed that the injuries or symptoms she claim resulted from essure decrease or resolve following essure removal.Her pain was stopped.Discrepant information date of removal given as 15aug2012.She had been treated for pain, migration, perforation.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.4 kg/sqm.Concerning the injuries reported in this case, the following one/ones, events uterine perforation, fallopian tube perforation and pelvic pain were confirmed by the medical records.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-may-2020: pfs received.Event psych injury, post removal complications added.Event outcome for pain, bleeding, migration/perforation changed to recovered.We received a lot number in this case.A technical investigation was 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.
 
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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 Key6993007
MDR Text Key90770434
Report Number2951250-2017-05876
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,health professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2014
Device Model NumberESS305
Device Lot Number869763
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACETAMINOPHEN; ACETAMINOPHEN; GIANVI; MICRONOR
Patient Outcome(s) Other; Required Intervention;
Patient Age26 YR
Patient Weight65
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