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

Model Number ESS305

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pregnancy (3193)

Event Type  Injury  

Event Description

This spontaneous case report was received from a nurse at a gynecologist/obstetrician's office in the united states on 27-jan-2014.The report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and was pregnant with the essure coils (device ineffective).No information was given on patient's history, past drugs, concomitant medication and concurrent conditions.On an unspecified date, the patient had essure (fallopian tube occlusion insert) inserted for contraception.On an unspecified date, the patient came in the office and was pregnant and had essure coils.No further details were reported.Outcome was reported as unknown, reporter was unsure if essure was continued.Reporter did not assess device-event relationship.Follow-up received on 17-feb-2014: no new information was provided.Follow-up information was received on 21-nov-2014 via essure health care provider pregnancy questionnaire.Patient's previous gynecological interventions, problems or procedures and any other relevant medical history or concurrent conditions were denied.She had 04 previous pregnancies with 02 live births and 02 abortions.Elective abortions, therapeutic abortions and ectopic pregnancies were denied.Essure was placed at another institution.Per patient, she never had post-essure hsg (hysterosalpingogram).The first day of the patient's last menstrual period was (b)(6) 2013.On (b)(6) 2013 an ultrasound was performed and showed 7-0 weeks iup (interpreted as intra-uterine pregnancy), live, singleton.Expected date of delivery (b)(6) 2014.There were no complications and she decided to continue the pregnancy.At that time, essure was not removed and removal was not planned.Complications during pregnancy included preterm contraction.On unspecified date patient delivered a live birth.Delivery type was vaginal (nsdv - spontaneous vaginal delivery).On an unspecified date, patient underwent a total bilateral salpingectomy for essure removal.Hsg was performed post essure removal.Case upgraded to incident due to total bilateral salpingectomy.(b)(4).Final assessment: pregnancy is the condition of carrying developing offspring within the body.The time period during which this condition exists; gestation.Probable causes for pregnancy include: unsuccessful bilateral tubal occlusion (complete tissue ingrowth), expulsion (related to micro-insert placement accuracy), no 3-month confirmation test (hsg) or mis-read of hsg, lack of patient compliance to ifu (i.E.Use of alternate contraception until confirmation of bilateral occlusion).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.This is an anticipated event.Medical assessment: this ptc was initiated due to a lack of efficacy.A contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality deficit per se.In this particular case, also to a treatment non-compliance was reported as the patient did not perform the essure confirmation test to determine if tubal occlusion is present.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.No complaint sample was provided 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 medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted, never had post essure hsg (hysterosalpingogram) and became pregnant with essure coils (device ineffective).During pregnancy she had preterm contractions.She delivered a live birth.Later, a total bilateral salpingectomy for essure removal was performed.All reported events are listed in essure's reference safety information, except for preterm contractions which is unlisted.The reported salpingectomy was considered serious due to medical importance, while the remaining events were considered non-serious.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance, which included failure to return for the essure confirmation test (hsg) to determine if the inserts are in the correct location and tubal occlusion is present.In this particular, the patient did not perform hsg.Although pregnancy in the present case may be considered rather a consequence of non-compliant use, a causal relationship with the suspect insert cannot be excluded.Regarding total bilateral salpingectomy, although limited information was provided, since physician stated this procedure was performed for essure removal, it was considered as related to the suspect insert; and due to this intervention this case was regarded as incident.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided).Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Further information will be requested.

Manufacturer Narrative

Follow up from 18-mar-2015: the required number of follow-up attempts was completed, with no response to date.No further information is expected for this case.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted, never had post essure hsg (hysterosalpingogram) and became pregnant with essure coils (device ineffective).During pregnancy she had preterm contractions.She delivered a live birth.Later, a total bilateral salpingectomy for essure removal was performed.All reported events are listed in essure's reference safety information, except for preterm contractions which is unlisted.The reported salpingectomy was considered serious due to medical importance, while the remaining events were considered non-serious.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies occurred due to patient non-compliance, which included failure to return for the essure confirmation test (hsg) to determine if the inserts are in the correct location and tubal occlusion is present.In this particular, the patient did not perform hsg.Although pregnancy in the present case may be considered rather a consequence of non-compliant use, a causal relationship with the suspect insert cannot be excluded.Regarding total bilateral salpingectomy, although limited information was provided, since physician stated this procedure was performed for essure removal, it was considered as related to the suspect insert; and due to this intervention this case was regarded as incident.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided).Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.No further information is expected.

• 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: 4337033
• MDR Text Key: 5140913
• Report Number: 2951250-2014-00535
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2015
• 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): Other; Required Intervention
• Patient Age: 29 YR