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

Model Number ESS305

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Pregnancy (3193)

Event Date 07/01/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 03-oct-2014.It describes the occurrence of pregnancy in a (b)(6) female patient who had essure (fallopian tube occlusion insert), lot number b76632 implanted for contraception on (b)(6) 2014.In (b)(6) 2014 hsg (hysterosalpingogram) was performed and per radiologist presented with both tubes occluded, but only 1 micro insert was visualized.At the time of this report patient has been diagnosed as positive pregnancy.The physician was not sure if pregnancy was ectopic or intrauterine and did not know how far along pregnancy was.Essure was not removed.No further information was provided.The product technical complaint investigation and final assessment were received on 21-oct-2014.(b)(4).Final assessment: lot number b76632 reported is invalid.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 and 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 or device malfunction at this time.Medical assessment: this ptc was initiated due to a lack of efficacy.Contraceptive failure may occur under the use of any product and is not indicative of a quality deficit per se.No valid 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.No complaint sample was provided 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 medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and got pregnant and 1 micro insert was visualized.Patient has been diagnosed as positive pregnancy.The physician was not sure if pregnancy was ectopic or intrauterine.The events of positive pregnancy, not sure if pregnancy was ectopic and 1 micro insert was visualized (interpreted as device dislocation) are serious due to medical importance while positive pregnancy, not sure if pregnancy was intrauterine is non-serious.These events are listed for essure according to the reference safety information.Pregnancies (including ectopic pregnancies) have been reported among women with essure micro-inserts in place.Some of these pregnancies were due to patient non-compliance.When pregnancy does occur after essure placement, the relative risk that it will be an ectopic pregnancy is higher than for women who do not have essure in place.Also, during essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case, it was reported that 3 months after essure insertion, a hysterosalpingogram was performed and the result showed both tubes occluded.Temporal relationship between the events and suspect insert is unknown.Considering the event's nature, a causal relationship between the events and suspect insert cannot be excluded, and it was therefore considered an incident.An initial ptc analysis was done but the lot number reported as b76632 was invalid and therefore a new ptc assessment was required.Further information has been requested.

Manufacturer Narrative

Follow-up from 13-jul-2015: the required number of follow-up attempts has been completed, with no response to date.No further follow-up will be pursued.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and got pregnant and 1 micro insert was visualized.Patient has been diagnosed as positive pregnancy.The physician was not sure if pregnancy was ectopic or intrauterine.The events positive pregnancy, not sure if pregnancy was ectopic and 1 micro insert was visualized (interpreted as device dislocation) are serious due to medical importance while positive pregnancy, not sure if pregnancy was intrauterine is non-serious.These events are listed for essure according to the reference safety information.Pregnancies (including ectopic pregnancies) have been reported among women with essure micro-inserts in place.Some of these pregnancies were due to patient non-compliance.When pregnancy does occur after essure placement, the relative risk that it will be an ectopic pregnancy is higher than for women who do not have essure in place.Also, during essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case, it was reported that 3 months after essure insertion, a hysterosalpingogram was performed and the result showed both tubes occluded.Temporal relationship between the events and suspect insert is unknown.Considering the event's nature, a causal relationship between the events and suspect insert cannot be excluded, and it was therefore considered an incident.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further information could not be obtained.

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: 4210406
• MDR Text Key: 4985448
• Report Number: 2951250-2014-00467
• 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,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B76632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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): Other
• Patient Age: 35 YR