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

Model Number ESS305

Device Problem Separation Failure (2547)

Patient Problems Emotional Changes (1831); Hemorrhage/Bleeding (1888); Pain (1994); Burning Sensation (2146); Abdominal Cramps (2543)

Event Date 06/04/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from a consumer via physician (case# mw5036543) in united states on 21-jul-2014 which refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted.Essure was inserted on (b)(6) 2014.Consumer stated that procedure lasted 2 hours and had a day surgery appointment the next day.Her physician tried to insert the first coil into her right fallopian tube.When he hit release the coil did not release.He repeated it several more times before getting a new device.By this time consumer was in immense, shooting pain.Physician then inserted the new coil without any trouble, but this continued to cause even greater pain.A coil was inserted in the left tube without any difficulty.After the procedure he looked at the device and realized that the first device did in fact release a coil into her fallopian tube, so she had two coils in one tube due to a faulty device and negligence on her physician´s part.Since then she has had immense cramping in her right side that feels like its burning, and is radiating into her thigh and across lower back.She woke up several times during the night from pain.The day after the initial procedure, she went to the surgical center to go under general anesthesia and remove the 2nd coil of her right fallopian tube.Physician pulled it out, and the device was bent on the front and looked to be missing coils from the photos.The original faulty device was still in her tube.There were no coils in her cervix because the device was too far in.She missed work for several days and experienced severe mental anguish, and extreme pain.She has been also bleeding since, and she was not sure if it was her period or a side effect.Follow-up received on 30-jul-2014: new reporter was added.The reporter stated that the consumer was in surgery to get bayer product removed.She did not want more contact with company.Ptc investigation result was received on 05-aug-2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: when a term like "missing coils" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless additional detail is provided in the event description, it is difficult to determine if the reporter is describing an event where the micro-insert actually broke into individual pieces, if the micro-insert bent or stretched into an unintended shape, and hence was considered by the reporter to be "broken".Since neither product was returned for inspection nor do we have a photograph of the actual device, we cannot determine exactly what the failure is.Based on our experience with device complaints of a similar nature, it is likely the reporter is referring to an event in which the micro-insert was bent or stretched into a shape which rendered the device to be unusable, and hence, "broken." since no product was returned for investigation, we are unable to confirm any quality defect or device malfunction at this time.Conclusions: the report did not state a patient injury occurred.The possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: the medical events reported are not necessarily indicative of a quality defect.This case reported technical issues of malfunction due to deployment issue where device appeared not to release but had released the device resulting in misuse.Additionally reported was off label use with one of the two coils removed next day resulting in complication of removal due to use error (appeared bent) and apparent breakage.These reported technical and usability issues 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" and noted that a breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Company causality comment: this medically confirmed report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced physician pulled essure out and looked to be missing coils , device is in too far and bleeding since essure procedure.Experienced physician pulled essure out and looked to be missing coils is considered non-serious, while the remaining events were considered serious due to medical importance.All events are listed in the reference safety information for essure.The event experienced physician pulled essure out and looked to be missing coils (assumed as device breakage) was regarded as near-incident due to the reported breakage.Single cases have been reported of essure breakage.In this particular case physician pulled it out, and the device was bent on the front and looked to be missing coils from the photos.During essure 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 there were no coils in her cervix because the device was too far in, considered a device dislocation.The event bleeding since essure procedure was assumed as genital haemorrhage which may occur after essure insertion; this event was regarded as non-incident.Based on the available information and due to lack of alternative explanation, causality between the events above and essure use was considered as related.Additionally non-serious events were reported.Upon receipt of follow-up information a new reporter stated that the consumer was in surgery to get bayer product removed, however as no information was provided about the type and reason for this procedure the case was maintained as near-incident.Further contact was not allowed.A product technical analysis was performed and concluded that based on the information available, there is no reason to suspect a quality defect.

Manufacturer Narrative

After internal review on (b)(4) 2014, further correction was made regarding the information received on (b)(4) 2014: this is a spontaneous case report received from a consumer via regulatory authority (case# mw5036543).The incident category was amended to incident.Due to conditions reported in the insertion procedure, complication of device insertion was added as event.The field duration of implantation was left blank.Company causality comment: this non-medically confirmed report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced bleeding since essure procedure; physician pulled essure out and looked to be missing coils (interpreted as device breakage) and device is in too far (device dislocation).All reported events were considered as serious due to medical importance and are listed in the reference safety information for essure, except for the reported device breakage, which is non-serious.This case, previously considered other reportable incident, was after a company internal review amended to incident since it was stated during follow-up that the consumer was in surgery to get bayer product removed.Single cases have been reported of essure breakage, mainly during insert removal attempts.In this particular case the consumer reported a difficult essure insertion, the physician placed two coils in the right fallopian tube (regarded as device misuse), in the next day he tried to remove the second coil of this tube and when he pulled essure out it looked to be missing coils, she also stated that there were no coils in cervix because the device was too far in; considering the close temporal relationship between the reported events and essure procedure a causal relationship with the suspect insert cannot be excluded.Regarding bleeding since essure procedure, genital bleeding and menses pattern changes may occur after essure insertion; therefore this event was considered as related to the suspect insert.Additionally non-serious events were reported.A product technical analysis was performed and concluded that based on the information available, there is no reason to suspect a quality defect of the product.Further contact was not allowed.

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: 4017932
• MDR Text Key: 4693785
• Report Number: 2951250-2014-00336
• 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,Consumer,consumer,other
• Reporter Occupation: Other
• 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: 08/18/2014
• 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?: No
• Date Manufacturer Received: 07/30/2014
• 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): Other