MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS205

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death, Intrauterine Fetal (1855); Pregnancy (3193)

Event Type  Death  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in september 2015.This is a spontaneous case report received from a regulatory authority ((b)(4)) in united states on 06-aug-2015 which refers to a fetus whose mother of unspecified age had essure (fallopian tube occlusion insert) inserted in 2006.The mother had severe complications which led to a complete hysterectomy at almost (b)(6)weeks pregnant.The fetus died (mother's case (b)(4)).Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus.At (b)(6) weeks of consumer's pregnancy, she was submitted to a hysterectomy due to severe complications (unspecified) and the fetus died.The reported event was considered serious due to fatal outcome and is unlisted according to essure's reference safety information.In this particular case, limited information was provided.The complications experienced by the mother were not specified and no information was provided about fetal disorders.Nevertheless, considering the fetus died during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded.Therefore, the reported event was considered as possibly related to the suspect insert.A product technical analysis is being sought.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Product technical complaint investigation and final assessment were received on (b)(6)2015: (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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due 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.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 was available for a 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, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus.At 20 weeks of consumer's pregnancy, she was submitted to a hysterectomy due to severe complications (unspecified) and the fetus died.The reported event was considered serious due to fatal outcome and is unlisted according to essure's reference safety information.In this particular case, limited information was provided.The complications experienced by the mother were not specified and no information was provided about fetal disorders.Nevertheless, considering the fetus died during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded.Therefore, the reported event was considered as possibly related to the suspect insert.In this case neither batch number nor complaint sample were available for a 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.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Internal correction on 24-nov-2015.During internal review it was notified that the previously reported initial receipt date 06-aug-2015 is incorrect.The correct initial receipt date of the case is 09-aug-2015.

Manufacturer Narrative

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

Manufacturer Narrative

This case was initially received via regulatory authority (fda, reference number: fda-2014-n-0736-0186) on 06-aug-2015.The most recent information was received on 10-jul-2020.This spontaneous case was reported by a consumer and describes the occurrence of foetal death ('baby died') in a foetus whose parent had inserted essure (ess205) at the time of conception.Other product or product use issues identified: foetal exposure during pregnancy "essure micro-insert exposure in utero" in 2008.The foetus's mother was exposed to essure (ess205) during the first and second trimesters.In 2006, the parent had essure (ess205) inserted.On an unknown date, the foetus was diagnosed with foetal death (seriousness criterion death).The reported cause of death was fetal death.The reporter provided no causality assessment for foetal death with essure (ess205).Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 10-jul-2020: quality-safety evaluation of ptc + correction from gsl (device removal field updated); after internal review, listedness/anticipatedness of event foetal death was updated to listed in accordance to the reference safety information, date of essure insertion in mother added.This case refers to the fetus of a mother who had essure (fallopian tube occlusion) inserted approx.2 years before pregnancy.At 20 weeks of consumer's pregnancy, she was had to undergo a hysterectomy due to severe complications (unspecified) and the fetus died.Fetal death is anticipated according to the reference safety information of essure.In this particular case, limited information was provided.The complications experienced by the mother and the underlying rationale for the hysterectomy were not specified and no information was provided about fetal disorders.Nonetheless, considering that fetal demise occurred during the second trimester of gestation, a mechanical interference between essure and the developing pregnancy cannot be completely excluded (related).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• MDR Report Key: 5041671
• MDR Text Key: 24536461
• Report Number: 2951250-2015-00668
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Followup,Followup,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other