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

Model Number ESS305

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Death (1802); Perforation (2001); Pregnancy (3193)

Event Type  Death  

Event Description

This is a spontaneous case report received form a social media (website) in united states on (b)(6)-2104 which refers to a baby of unspecified age who was exposed to essure (fallopian tube occlusion insert) in utero and experienced the adverse events as described below.The mother had the essure procedure and she ended up getting pregnant.She couldn't have essure removed and in the 25th week of the pregnancy it broke and migrated, perforating the amniotic fluid.The child didn't make it.The linked mother's case is (b)(4).Ptc investigation results was received 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 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 confirm that all parts are accounted for the inspect the device 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 at this time.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.No information about the exact cause of child death was provided (prematurity, infection); however given the gestation age at event occurrence a mechanical interference between essure and the developing pregnancy cannot be excluded and the reported event was, therefore considered as related to the suspect insert.Follow-up information cannot be obtained since this is a social media case.A product technical complaint (ptc) analysis was performed and concluded that based on the information available, there is no reason to suspect a quality defect of the product.

Manufacturer Narrative

This non-medically confirmed, spontaneous case report was received from a social media (website) and refers to a baby who had essure micro-insert exposure in utero and in the 25th weeks of mother's pregnancy the child didn't make it.Reporter's causality assessment was not provided.The 25th week of the pregnancy/the child didn't make it interpreted as a death of a premature baby with less than 26 weeks; was considered serious and a incident due to the reported death.This event is unlisted according to the reference safety information for essure.Preterm premature rupture of membranes is a rupture of membranes prior to 37 weeks gestation; it is associated with preterm deliveries and when it occurs remote from term, significant risks of morbidity and mortality are present for both the fetus and the mother.In this particular case, it was reported that at 25th week of the mother's pregnancy the essure broke and migrated, perforating the amniotic fluid and the child didn't make it.

Manufacturer Narrative

Data correction for us 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: 3986916
• MDR Text Key: 20788000
• Report Number: 2951250-2014-00299
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2014
• Is this an Adverse Event Report?: No
• 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: 06/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death