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

Model Number ESS305

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001); Respiratory Distress Syndrome of Newborns (2046)

Event Date 09/18/2013

Event Type  Death  

Event Description

Underdeveloped lungs in premature baby [immature respiratory system] premature baby (b)(6) [premature baby 26 to 32 weeks].Case description: serious, related, unlisted (incident, unanticipated).This spontaneous case report was rec'd from a consumer in the united states on (b)(6) 2014 via internet.The report refers to the prematurely ((b)(6) week) born male baby whose mother of unspecified age had essure (fallopian tube occlusion insert) inserted and experienced pregnancy with essure, essure failed, and errant coil perforated the amniotic sac causing her water to break, and mother went into premature labor at (b)(6) weeks.Baby's under-developed lungs could not sustain him and he died on the day he was born.Mother's case was reported at bayer case number (b)(6).No info was given on mother's history, past drugs, concomitant medication and concurrent conditions.On an unspecified date, the mother had essure (fallopian tube occlusion insert) inserted for permanent birth control.On an unspecified date, the mother experienced pregnancy with essure, essure failed, and mother went into premature labor at (b)(6) weeks after an errant coil perforated the amniotic sac causing her water to break.Male baby was born alive, and his under-developed lungs could not sustain him and he died on the day he was born.Reporter assessed the events were related to essure.F/u -ptc investigation result was rec'd on (b)(6) 2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and pyc global number (b)(6).Final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in gpv database for a more detailed statistical medical evaluation is possible without a batch number.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the info available, there is no reason to suspect a quality defect.F/u (b)(6) 2014: reporter denies further contact.Company causality comment: a spontaneous case of premature baby (b)(6) weeks and underdeveloped lungs in premature baby in a male baby, whose mother went into premature labor at (b)(6) weeks after errant coil perforated the amniotic sac causing her water to break in association with mother;s essure (fallopian tube occlusion insert) use was reported by a consumer.The male baby died on the day he was born.This case was not medically confirmed.Premature baby (b)(6) weeks and its complication underdeveloped lungs in premature baby were regarded serious due to fatal and unlisted for essure in the reference safety info.Given the compatible temporal relationship a contributive effect of dislocated essure in baby's mother to the occurrence of the events in the baby cannot be excluded (related).Both events were regarded as incidents.According to the rec'd ptc (product technical complaint) analysis there is no reason to suspect a quality defect of the product.

Manufacturer Narrative

Final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the info available, there is no reason to suspect a quality defect.

Manufacturer Narrative

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

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of fatal premature baby ('premature baby 26 weeks') and fatal immature respiratory system ('underdeveloped lungs in premature baby') in a male foetus whose mother had inserted essure during pregnancy.Other product or product use issues identified: foetal exposure during pregnancy "foetal exposure during pregnancy".The mother's concurrent conditions included premature rupture of membranes and preterm labour.On an unknown date, the mother had essure inserted.On (b)(6) 2013, the foetus was diagnosed with premature baby (seriousness criterion death) and immature respiratory system (seriousness criterion death).The foetus died on (b)(6) 2013 and the reported cause of death was premature baby death and immature respiratory system.The reporter considered immature respiratory system and premature baby to be related to essure.Quality-safety evaluation of ptc: final assessment: no lot number provided; therefore, no lot history record (lhr) review could be done.No device returned; therefore, no device investigation could be completed.No conclusions can be drawn.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 20-mar-2020: upon receipt of new follow-up, it was noted that information on case (b)(4) should have been added in this current case.Event foetal exposure during pregnancy was added.Date of birth and date of death added.Maternal history updated.A spontaneous case of premature baby (b)(6) and underdeveloped lungs in premature baby in a male baby, whose mother went into premature labor at (b)(6) after errant coil perforated the amniotic sac causing her water to break in association with mother's essure (fallopian tube occlusion insert) use was reported by a consumer.The male baby died on the day he was born.This case was not medically confirmed.Premature baby (b)(6) is anticipated, while its complication underdeveloped lungs in premature baby is unanticipated in the reference safety information for essure.Given the compatible temporal relationship, a contributive effect of dislocated essure in baby's mother to the occurrence of premature rupture of membranes and premature labour, leading to the complications reported in the baby, causality between essure and the reported events cannot be 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
• 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; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 3853615
• MDR Text Key: 4656318
• Report Number: 2951250-2014-00178
• 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: Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2014
• 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