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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION

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BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS305
Device Problem Break
Event Type  Injury  
Manufacturer Narrative

Follow up 24-jun-2016: legal claim was received from lawyer on behalf of plaintiff. Essure insertion date was updated from (b)(6) 2012 to 2013. Sometime after undergoing the essure procedure plaintiff was admitted to the emergency room and a doctor confirmed that plaintiff was pregnant. During this visit to the emergency room, she was told that her right-side essure coil had ruptured a part of her body and this was apparently confirmed by an ultrasound. Shortly after undergoing the essure procedure, plaintiff began to suffer severe menstrual, abdominal and back pain as well as heavy bleeding. Additionally, after being implanted with essure plaintiff began suffering from symptoms of depression and fatigue. Ever since undergoing the essure procedure, she also began suffering weight fluctuations, pain during intercourse. She has also suffered from severe migraines for which she had no history of suffering prior to undergoing the implantation of essure. Company causality comment: initially it was a non-medically confirmed, spontaneous case report upon receipt legal claim this case was considered a legal case and refers to a plaintiff/female consumer who had essure (fallopian tube occlusion insert) inserted and she got pregnant and had an elective abortion. It was also reported that essure rod on the right was broken. She also had right-side essure coil ruptured a part of her body and heavy bleeding. All events are listed in essure reference safety information except breakage that is unlisted. However, anticipated according to product technical analysis. Pregnancy and breakage are non-serious while the other events are serious. During essure micro-insert therapy there is a risk of a uterine perforation mainly during insertion, also genital bleeding may occur during essure use, given events' nature causality cannot be excluded. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. In this case, hysterosalpingogram was performed an unknown time after essure insertion and the result showed bilateral occlusion. A causal relationship between the suspect insert and the reported pregnancy cannot be excluded. During difficult insertion/removals, single cases have been reported of essure breakage. In this case, consumer started had sharp intermittent daily pain about 1 year and 10 months after insertion. Ultrasound was performed and showed essure rod on the right was broken. A causal relationship between this event and suspect insert cannot be excluded. This case was initially regarded as other reportable incident after received new event uterine perforation was regarded as incident due to serious injury related to essure. The performed product analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

 
Event Description

This is a spontaneous case report received from a consumer in united states on (b)(6) 2015. It describes the occurrence of pregnancy in a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2012 (no details provided). Consumer stated that she had an essure placed and the hysterosalpingogram test showed bilateral occlusion (date not reported). She started having a sharp intermittent daily pain in (b)(6) 2014 and went to her hcp (health care professional) at that same month. They did a vaginal ultrasound and said the essure rod on the right was broken and on the left rod was fine. She got pregnant in (b)(6) 2014 and had an elective abortion in (b)(6) 2014. The pain has been continuing and at time of the initial report was about a 7 in a scale of a 1 to 10. Her hcp did not do essure removals without removing the whole tube and she did not want that. She wanted to know a hcp that could remove it. No additional information was provided. Ptc investigation result was received on 07-may-2015. This adverse event report is related to a product technical complaint (ptc). The bayer reference number for the ptc report is: (b)(4) and ptc global number (b)(4). Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint. Typically, we would inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We were unable to confirm any quality defect or device malfunction at this time. The possibility of micro-insert breaking during the procedure is an anticipated event. Medical assessment: this ptc was initiated due to a product quality issue. In addition, the ae case refers to a lack of efficacy. A contraceptive failure may occur with the use of any contraceptive and is not indicative of a quality deficit per se. Neither batch number nor complaint sample were available for a technical investigation. The technical investigation concluded unconfirmed quality defect. The reported adverse events are known, possible, undesirable events and not indicative of a quality deficit per se. No batch number was reported. Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible. In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and she got pregnant and had an elective abortion. It was also reported that essure rod on the right was broken. The event pregnancy is listed in the reference safety information for essure, essure rod on the right was broken is listed according to product technical analysis (ptc) results. Both events are non-serious. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. Some of these pregnancies occurred due to patient non-compliance, which included failure to return for the essure confirmation test to determine if the inserts are in the correct location and tubal occlusion is present. In this case, hysterosalpingogram was performed an unknown time after essure insertion and the result showed bilateral occlusion. A causal relationship between the suspect insert and the reported pregnancy cannot be excluded. During difficult insertion/removals, single cases have been reported of essure breakage. In this case, consumer started experiencing sharp intermittent daily pain about 1 year and 10 months after insertion. A vaginal ultrasound was performed and the result showed essure rod on the right was broken. A causal relationship between this event and suspect insert cannot be excluded. This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances. The performed ptc analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Further information is being sought.

 
Manufacturer Narrative

On (b)(6) 2012, the patient started essure. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received essure during the first trimester of pregnancy. In (b)(6) 2014, the patient experienced device breakage ("essure rod on the right was broken") and pregnancy with contraceptive device ("pregnant"). On an unknown date, the patient experienced uterine perforation (seriousness criterion medically significant) with abdominal pain, genital haemorrhage (seriousness criterion medically significant), back pain ("back pain"), depression ("depression"), fatigue ("fatigue"), weight fluctuation ("weight fluctuations"), dyspareunia ("pain during intercourse"), migraine ("severe migraines") and dysmenorrhoea ("severe menstrual pain"). Essure treatment was not changed. At the time of the report, the uterine perforation, device breakage, pregnancy with contraceptive device, back pain, depression, fatigue, weight fluctuation, dyspareunia, migraine and dysmenorrhoea outcome was unknown and the genital haemorrhage outcome was unknown. Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2012: hysterosalpingogram result was proper placement, bilateral tube occlusion. In (b)(6) 2014: pregnancy test result was positive. On (b)(6) 2014: pregnancy test result was positive. In (b)(6) 2014: ultrasound vagina: essure rod on the right was broken, left was fine, right coil ruptured a part of her body. Most recent follow-up information incorporated above includes: on (b)(6) 2017: follow up from lawyer: essure inserted on (b)(6) 2012, date of hsg, date of pregnancy diagnosis, new event added. Company causality comment: initially it was a non-medically confirmed, spontaneous case report upon receipt legal claim this case was considered a legal case and refers to a plaintiff/female consumer who had essure (fallopian tube occlusion insert) inserted and she got pregnant and had an elective abortion. It was also reported that essure rod on the right was broken. She also had right-side essure coil ruptured a part of her body and heavy bleeding. All events are listed in essure reference safety information except breakage that is unlisted. However, anticipated according to product technical analysis. Pregnancy and breakage are non-serious while the other events are serious. During essure micro-insert therapy there is a risk of a uterine perforation mainly during insertion, also genital bleeding may occur during essure use, given events' nature causality cannot be excluded. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. In this case, hysterosalpingogram was performed an unknown time after essure insertion and the result showed bilateral occlusion. A causal relationship between the suspect insert and the reported pregnancy cannot be excluded. During difficult insertion/removals, single cases have been reported of essure breakage. In this case, consumer started had sharp intermittent daily pain about 1 year and 10 months after insertion. Ultrasound was performed and showed essure rod on the right was broken. A causal relationship between this event and suspect insert cannot be excluded. This case was initially regarded as other reportable incident after received new event uterine perforation was regarded as incident due to serious injury related to essure. The performed product analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

 
Manufacturer Narrative

Follow-up from 07-aug-2015: the required number of follow-up attempts was completed, with no response to date. Case closed. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and she got pregnant and had an elective abortion. It was also reported that essure rod on the right was broken. The event pregnancy is listed in the reference safety information for essure, essure rod on the right was broken is listed according to product technical analysis (ptc) results. Both events are non-serious. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. Some of these pregnancies occurred due to patient non-compliance, which included failure to return for the essure confirmation test to determine if the inserts are in the correct location and tubal occlusion is present. In this case, hysterosalpingogram was performed an unknown time after essure insertion and the result showed bilateral occlusion. A causal relationship between the suspect insert and the reported pregnancy cannot be excluded. During difficult insertion/removals, single cases have been reported of essure breakage. In this case, consumer started experiencing sharp intermittent daily pain about 1 year and 10 months after insertion. A vaginal ultrasound was performed and the result showed essure rod on the right was broken. A causal relationship between this event and suspect insert cannot be excluded. This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances. The performed ptc analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Further information could not be obtained.

 
Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

 
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Brand NameESSURE
Type of DeviceINSERT, TUBAL OCCLUSION
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, CA 13353
GERMANY 13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd, p.o. box 915
p.o. box 915
whippany , NJ 07981-0915
MDR Report Key4784158
Report Number2951250-2015-00331
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type Other,Consumer,CONSUMER,OTHER
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberESS305
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/20/2015 Patient Sequence Number: 1
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