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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problem Perforation (2001)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Follow up information received on (b)(6) 2014 from the physician: patient's demographic data were updated.She was (b)(6) at time of the event and her bmi was (b)(6).Patient's historical conditions included 7 pregnancies with 6 live births and one voluntary termination of pregnancy.On (b)(6) 2014, the patient had essure easily inserted under local anesthesia.Ostium viewing was easy.Uterus had no anomaly before essure and placement was during follicular phase.During hysteroscopy fluid loss was upper than 1500 cc and insertion procedure didn't take more than 20 minutes.There were no complaints from the patient immediately after device placement.The event perforation occurred in 2013, one year after insertion.No organ or intra-abdominal structure was perforated.Perforation occurred with coils after deployment.Diagnosis was performed by x-ray.In left fallopian tube, essure was correctly placed.In right fallopian tube, there was intra-pelvic complete perforation.Physician also reported that patient was pregnant (8 weeks of amenorrhea).No confirmation test for essure was performed and essure was not removed.Laparoscopic removal of essure failed.No further information was provided.Follow-up information was received on (b)(6) 2014 from the physician.Oestroprogestative pill had been used as alternative contraception following essure placement and before confirmation of essure efficiency.Confirmation test for essure was not performed.Pregnancy was medically confirmed.Interruption was the decision of the patient concerning pregnancy.Implants were not well placed at the time of pregnancy diagnosis.Implants were not removed.No further information will be provided.Case closed.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 experienced perforation: implant in patient's abdomen (intra-pelvic complete perforation) and pregnancy.The first event is serious due medical importance, listed in the reference safety information for essure and regarded as incident, since an intervention (celioscopy) was performed.The other event is non-serious, listed and regarded as non-incident.The perforation of the uterus and fallopian tubes may occur during hysteroscopy, as well as during device placement.Unintended pregnancies may occur during any contraceptive use.In this particular case, the physician stated that there were no complications during the insertion procedure.Also, it was reported the perforation on the right fallopian tube (intra-pelvic complete perforation) has occurred one year after the insertion, was diagnosed per x-ray and no organ or intra-abdominal structure was perforated.No confirmation test for essure was performed.A celioscopy did not find essure and the device could not be removed.In fact, the perforation could cause a lack of blockage in right tube and therefore could be the reason for the occurrence of the pregnancy.However, it is not possible to know when this perforation actually happened.Based on this explanation, causal relationship between the events and essure use cannot be excluded and a lack of efficiency of the device must be considered.Additionally non-serious event device ineffective, laparoscopic removal of essure failed, 8 weeks of amenorrhoea and no confirmation test for essure was performed were reported.According to product technical compliant investigation results, the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.Interruption was the decision of the patient concerning pregnancy.

Event Description

This is a spontaneous case report received from a physician via sales representative in (b)(4) on (b)(4) 2014 which refers to a female patient of unspecified age who had essure inserted and it was found in abdomen (perforation).The patient wanted essure implant to be removed.Under brilliance amplifier, the physician saw that the implant was not well placed: it was found in abdomen.But with celioscopy, implant was not found and so it could not be removed.No further information was provided.(b)(4) bhp local drug safety department assessed the causal relationship with essure as not applicable according to the (b)(4) method of causality.

Manufacturer Narrative

Ptc investigation result was received on (b)(4) 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 and inspect the device to look for any manufacturing during device placement; this risk is inherent with any hysteroscopic procedure.In this particular case, the physician reported that the patient wanted essure implant to be removed but the physician saw that the implant was not well placed: it was found in abdomen.The exact date and the mechanism of perforation are not known.A causal relationship between essure and the event cannot be excluded.According to ptc analysis, at the time of this medical assesment the technical investigation concluded "unconfirmed quality defect." based on the information available, there is no reason to suspect a quality defect.

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: 3954671
• MDR Text Key: 11944957
• Report Number: 2951250-2014-00292
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• 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

• 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
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 07/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/19/2014; 01/19/2017
• 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
• Patient Age: 44 YR
• Patient Weight: 80