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

Model Number ESS305

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problems Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994); Cramp(s) (2193)

Event Date 06/15/2015

Event Type  Injury  

Event Description

This spontaneous case report received from a gynecologist/obstetrician in (b)(6) on 15-oct-2015 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014.Gynecologist reported that on (b)(6) 2014 at the insertion procedure, left essure did not unfold.According to health care professional, essure was pulled out and a new essure had been inserted.Ultrasound revealed correct positions of the coils.On hysterosalpingogram results there was a doubt regarding position of left essure.On (b)(6) 2014 test was sent to panel (as reported) (had to wait for 4 months for the results) and based on the results it had been decided to check the position of essure by laparoscopy.On (b)(6) 2015 laparoscopic check of essure was performed and good position was confirmed.On (b)(6) 2015 patient returned and complained of increase in dysfunctional blood loss, itching over entire body, increased cramps during menstrual period and pain in hip and knee.On (b)(6) 2015 uterine removal was performed.On (b)(6) 2015 patient visited physician and complaints were resolved.Case considered to be closed.Company causality comment: this is a medically confirmed spontaneous case report.It refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and a year after the insertion, the patient complained of increase in dysfunctional blood loss (interpreted as genital bleeding) among other non-serious events.The genital bleeding is serious due to its medical importance and listed in the reference safety information for essure.Although the ultrasound and laparoscopic check showed that inserts were correctly placed, given the implied temporal relationship and lack of alternative explanation, a causal relationship between essure and the genital bleeding cannot be excluded.This case is regarded as incident since a device removal was required.Further information and a product technical complaint analysis are expected.

Manufacturer Narrative

Product technical complaint (ptc) investigation result was received on 10-dec-2015: (b)(4).Final assessment: deployment difficulty is defined as a failure of the micro-insert outer coils to expand from the wound down position.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper deployment: rollback to initial hard stop, depress button and perform final rollback.Under normal circumstances, when the physician completes the proper essure placement steps, the release ribbon should disengage from the platinum half band (welded onto outer coils of micro-insert).Once disengagement occurs, the outer coils should expand.If it does not, this is referred to deployment difficulty.Several factors can contribute to a deployment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from expanding and releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of me manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of a deployment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The risk to the patient for this failure mode was assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in the design fmea.Medical assessment: based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar adverse event cases is not applicable.Follow-up from 04-jan-2016: the required number of follow-up attempts has been completed, with no response to date.No further follow-up will be pursued.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 14-dec-2015 for the following meddra preferred term: genital haemorrhage.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: this is a medically confirmed spontaneous case report.It refers to a (b)(6)-year-old female patient who had essure (fallopian tube occlusion insert) inserted and a year after the insertion, the patient complained of increase in dysfunctional blood loss (interpreted as genital bleeding) among other non-serious events.The genital bleeding is serious due to its medical importance and listed in the reference safety information for essure.Although the ultrasound and laparoscopic check showed that inserts were correctly placed, given the implied temporal relationship and lack of alternative explanation, a causal relationship between essure and the genital bleeding cannot be excluded.This case is regarded as incident since a device removal was required.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and 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: 5213201
• MDR Text Key: 30853869
• Report Number: 2951250-2015-01393
• Device Sequence Number: 1
• Product Code: HHS
• 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: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• 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: 12/10/2015
• 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; Required Intervention
• Patient Age: 39 YR