MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problem Defective Device (2588)

Patient Problem Ectopic Pregnancy (1819)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a general practitioner in (b)(6) on (b)(6) 2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.General practitioner mentioned that he saw a patient a long time ago with an ectopic pregnancy on essure.Ptc investigation result was received on (b)(6) 2015.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 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.No new failure mode has been identified.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 defect 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 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 female patient who had an ectopic pregnancy after essure (fallopian tube occlusion insert) insertion.The reported event was considered serious due to medical importance and is listed according to essure's reference safety.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place.Some of these pregnancies were due to patient non-compliance.When a pregnancy occurs after essure placement, the relative risk that it will be an ectopic pregnancy is higher than for women who do not have essure.In this particular case, limited information was provided; nevertheless considering the reported event nature, a causal relationship with the suspect insert cannot be excluded.The product technical analysis concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit.Follow-up information is being sought.

Manufacturer Narrative

Follow-up received on 24-mar-2015 from general practitioner via account manager: the patient was (b)(6) old at time of the event.It was reported that the insertion procedure was probably in (b)(6) 2013.The general practitioner received a letter from the hospital regarding confirmation of ectopic pregnancy on (b)(6) 2013.Case is in follow-up.Follow-up received on 31-mar-2015 from gynecologist: information received states that gynecologist was not able to find an ectopic pregnancy in their electronic patient record.However, by a patient, in (b)(6) 2013, she was tested in the urine at home a (possible) weak positive pregnancy test which became negative shortly after during an irregular menstrual cycle.According to information provided by gynecologist and from gynecologist to general practitioner; the patient had essure inserted, without analgesics, 6 months (24 weeks) post-partum and during lactation, she had no menstruation/cycle as a consequence of lactation.Procedure went without problems with bettachi method (no-touch technique).Essure devices were simply inserted.Right 1 turn, left 2 turns, duration procedure 4.34 minutes.As remarks, gynecologist reported smooth insertion without resistance in both sides.No uterine abnormalities were found during insertion.On (b)(6) 2013, during outpatient follow-up no abnormalities were noted with essure devices (well in situ).As additional contraception after insertion patient used continue contraceptive measures, in this case condoms.On (b)(6) 2013 patient had transvaginal echo performed.No abnormalities were found.On (b)(6) 2013 a hysterosalpingogram was done and also showed no abnormalities (essure devices well in situ, tuba not accessible) and bilateral tuba occlusion was confirmed.In addition, gynecologist informed that did not report before because no (continuous) pregnancy and/or ectopic pregnancy was diagnosed; doubtful positive test also not confirmed (not seen by physician).Patient done the test by herself, not in hospital confirmed; shortly/days after test was negative.Case considered non-incident ptc investigation result received on 14-apr-2015 ptc global number (b)(4).Lot number a57110, production date 09/2012 and expiration date 09/20154.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.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a suspected 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 event is not indicative of a quality deficit per se and is considered unrelated by the company.No similar ae case reports have been received to date in relation to the reported batch.No batch signal could be identified.The batch documentation of the reported batch was reviewed.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 spontaneous case report was initially received from a general practitioner and later updated with information provided by a gynecologist who inserted essure (fallopian tube occlusion insert) in a (b)(6) female patient.The general practitioner initially believed the patient had an ectopic pregnancy with essure; however upon follow-up with gynecologist, he was unable to confirm this event and stated the patient had a weak positive pregnancy test which became negative shortly after.Considering this information; this case, initially regarded as an incident due to ectopic pregnancy (serious injury) was amended to non-incident; since it was confirmed it referred to a false positive pregnancy test and no serious injury occurred to the patient.Due to its nature, the reported false positive pregnancy test was considered as unrelated to essure.An updated product technical analysis (with data provided during follow-up) is being sought.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd.; milpitas CA 95035
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 4624357
• MDR Text Key: 22158535
• Report Number: 2951250-2015-00210
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: ESS305
• Device Lot Number: A57110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 28 YR