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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problems Hemorrhage/Bleeding (1888); Thrombus (2101); Abdominal Cramps (2543); Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) -2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on an unspecified date in 2014 for contraception.It was reported that in (b)(6)-2014, one week before essure confirmation test, patient had cramping and clot and saw a portion of the insert.It was expelled in the bleeding; it was if essure had fractured.On an unspecified date, hsg (hysterosalpingogram) was done and the remainder of the insert stayed in the patient.Both tubes were occluded and inserts were in correct position.Hcp (health care professional) retained the piece that was expelled in the bleeding.Result and assessment of the product technical complaint investigation received on 23-jan-2015: 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.The device breakage could not be confirmed.The hsg films are waiting to be reviewed by the physician consultant for further evaluation.Medical assessment: this ptc was initiated due to a reported product quality issue.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.The reported adverse events are known, possible, undesirable events and not indicative of a quality deficit 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.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.(b)(4).Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced clot/bleeding and it was if it had fractured / remainder of the insert stayed in the patient.Event clot/bleeding, interpreted as genital bleeding, is serious due to medical significance and listed in the reference safety information for essure, while event it was if it had fractured/ remainder of the insert stayed in the patient, interpreted as device breakage, is non-serious and unlisted.During essure micro-insert therapy abnormal genital bleeding and menses pattern changes may occur.Also, during difficult insertions/ removals single cases have been reported of essure breakage.In the present case, the exact date and mechanism of the breakage was not reported.Along with the genital bleeding the patient had cramping and part of insert was expelled in the bleeding (non serious events).A hysterosalpingogram was done and showed the remainder of the insert stayed in the patient.Therefore, considering the positive temporal relationship and nature of the events, a causal relationship between essure and the reported events cannot be excluded.This case was regarded as other reportable incident due to the reported device breakage (malfunction).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 have been requested.

Manufacturer Narrative

Follow-up received on 18-may-2015: the required number of follow-up attempts has been completed with no response to date.Case considered to be closed.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced clot/bleeding and it was if it had fractured / remainder of the insert stayed in the patient.Event clot/bleeding, interpreted as genital bleeding, is serious due to medical significance and listed in the reference safety information for essure, while event it was if it had fractured/ remainder of the insert stayed in the patient, interpreted as device breakage, is non-serious and unlisted.During essure micro-insert therapy abnormal genital bleeding and menses pattern changes may occur.Also, during difficult insertions/ removals single cases have been reported of essure breakage.In the present case, the exact date and mechanism of the breakage was not reported.Along with the genital bleeding the patient had cramping and part of insert was expelled in the bleeding (non serious events).A hysterosalpingogram was done and showed the remainder of the insert stayed in the patient.Therefore, considering the positive temporal relationship and nature of the events, a causal relationship between essure and the reported events cannot be excluded.This case was regarded as other reportable incident due to the reported device breakage (malfunction).The product technical analysis concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit.Further information could not be obtained.

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: 4510672
• MDR Text Key: 5404358
• Report Number: 2951250-2015-00078
• 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: 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: 05/18/2015
• Initial Date FDA Received: 02/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 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