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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
Event Type  Death  
Event Description

This case is a solicited case report received via social media (website) from a member of an essure problems support group in united states on (b)(6) 2015 which refers to a female's consumer daughter who was exposed to essure (fallopian tube occlusion insert) in utero. The reporter informed a case which occurred with one of the women from the group who was pregnant with essure implanted ((b)(6)). She found out she was expecting twins and posted on the group that she lost her babies (in 2014). Her placenta obtained a tear (metal coils could and did migrate out of fallopian tubes into uterus), she leaked fluid from her placenta at 15 weeks and ended up having to bury 2 beautiful little girls (this case refers to one of the 2 girls, please refer to the other girl case (b)(6)). It was also reported that she lost her babies because of migrating coils. Follow-up information received on 27-jan-2015: no further information is expected for this case. Company causality comment: this non-medically confirmed, solicited case report was received from a female consumer and refers to her daughter, who was exposed to essure micro-insert in utero and died due pregnancy complications in her mother. The reported fetal death was considered serious and is unlisted according to the reference safety information for essure. In this particular case, it was reported that consumer's twin daughters died after her mother experienced a placental tear and fluid leakage at 15 weeks of gestation; although no information about the exact cause of babies death was provided and discrepant information was received (gestational age is not clinically compatible with event's characteristics); a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert and this case was regarded as an incident. A product technical analysis will be sought.

 
Manufacturer Narrative

Follow-up information received on 15-may-2015 from social media: it was reported that babies died at (b)(6) because of essure. Company causality comment: this non-medically confirmed, solicited case report was received from a female consumer and refers to her daughter, who was exposed to essure micro-insert in utero and died due pregnancy complications in her mother. The reported fetal death was considered serious and is unlisted according to the reference safety information for essure. In this particular case, it was reported initially that consumer's twin daughters died after her mother experienced a placental tear and fluid leakage at (b)(6) of gestation. In the follow up, another reporter stated the death occurred at (b)(6). Although no information about the exact cause of babies death was provided and discrepant information was received regarding the gestational age, a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert and this case was regarded as an incident. The product technical analysis concluded unconfirmed quality defect and that there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Ptc investigation result was received on 18-mar-2015. This adverse event report is related to a product technical complaint (ptc). The bayer reference number for the ptc report is: 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 to look for any manufacturing deficiencies. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We are unable to confirm any quality defect or device malfunction at this time. No new failure mode has been identified. Medical assessment: this ptc was initiated due to a request for confirmation of quality. The reported adverse events are 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. Neither batch number nor complaint sample were available for further technical investigation. The technical assessment concluded unconfirmed quality defect. 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, solicited case report was received from a female consumer and refers to her daughter, who was exposed to essure micro-insert in utero and died due pregnancy complications in her mother. The reported fetal death was considered serious and is unlisted according to the reference safety information for essure. In this particular case, it was reported that consumer's twin daughters died after her mother experienced a placental tear and fluid leakage at 15 weeks of gestation; although no information about the exact cause of babies death was provided and discrepant information was received (gestational age is not clinically compatible with event's characteristics); a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported death was, thus considered as related to the suspect insert and this case was regarded as an incident. The product technical analysis concluded unconfirmed quality defect and that there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

 
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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
whippany , NJ 07981-0915
MDR Report Key4521252
Report Number2951250-2015-00122
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type Other,OTHER
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received05/15/2015
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/17/2015 Patient Sequence Number: 1
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