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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Death, Intrauterine Fetal (1855); Excessive Tear Production (2235); Fluid Discharge (2686)

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 (case number (b)(4)).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 (b)(6) weeks and ended up having to bury 2 beautiful little girls (this case refers to one of the 2 girls, for the other girl please refer to (b)(4)).It was also reported that she lost her babies because of migrating coils.Follow-up received on 27-jan-2015.No further information is expected for this case 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 (b)(6) 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 received on (b)(6) 2015 from social media: information received states that woman's twins 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 (b)(6) complications in her mother.The reported (b)(6) 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) of gestation.Although no information about the exact cause of (b)(6) death was provided and discrepant information was received regarding the gestational age, a mechanical interference between essure and the developing (b)(6) 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

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.A product technical analysis was performed and concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.

Manufacturer Narrative

Data correction for u.S.Reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 4523490
• MDR Text Key: 5409438
• Report Number: 2951250-2015-00123
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 02/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death