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

Model Number ESS305

Device Problems Microbial Contamination of Device (2303); Positioning Problem (3009)

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Weight Changes (2607)

Event Type  Injury  

Event Description

This study case report was received from an investigator in (b)(6) on (b)(6) 2009 and refers to a (b)(6) female patient who was involved in an observational company-sponsored study, study number: (b)(6).Additional information was received on (b)(6) 2009 and (b)(6) 2011.On (b)(6) 2011 follow-up information received qualifies this case as an incident.Study description: (b)(6).Patient´s medical history included five children (1 cesarean) and menstrual pain.She was on minipills and amenorrhea.Her uterus was not retroverted.On(b)(6) 2009, essure was easily inserted in two minutes.Nsaid was used as premedication.Uterine condition was normal and visualization was possible bilaterally.The number of externally visible coils in the uterine coils was three in the left side and one in the right side.Patient presented pain during insertion.No other procedure was performed at the time of insertion.On (b)(6) 2009, pain and bleeding were denied.Back contraception used was minipills.Ultrasound was performed and inserts were seen from the cavity to the horn.Conclusion was good inserts position.Final result of the procedure was considered successful and patient was satisfied.At 12 months visit, it was reported pelvic pain, irregular menstruation and weight loss.Lower abdominal pain throughout the year, not systematically at menstruation times.Two years later, an infection was reported.She underwent a removal of fallopian tubes up to 60% due to inflammation.No further information was provided.Additional information received on (b)(6) 2015: ptc (product technical complaint).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: there is no reason to suspect a causal relationship of the reported adverse events to a potential quality deficit based on this report.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in (b)(6).In this particular case a search in the database was performed on (b)(6) 2015 for the following (b)(6) preferred term: salpingitis.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 (b)(6) pt.Company causality comment: this study case report refers to a (b)(6) female patient, who was involved in observational company-sponsored study, (b)(6).Patient had essure (fallopian tube occlusion insert) inserted and experienced fallopian tube inflammation (infection).This event, seen as salpingitis, is serious due medical importance and listed in the reference safety information for essure.Salpingitis occurs when microorganisms ascend from the lower genital tract, infecting the fallopian tubes.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections, including salpingitis after insertion procedure (within 4 weeks).In this case, limited information was provided.Apparently, the inflammation occurred two years after insertion and it was not related to insertion procedure.However due to lack of plausible alternative explanation and considering local action of essure in the fallopian tubes, causality with suspect device use cannot be totally excluded.Since this event led to salpingectomy, this case is regarded as incident.According to technical analysis, there is no reason to suspect a causal relationship of the reported adverse events to a potential quality deficit.

Manufacturer Narrative

Follow-up information received on 25-jan-2016: the patient was not seen again in the unit, and the surgery was not performed in the unit.The reporter did not have further information to report for this patient.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 28-jan-2016 for the following meddra preferred term: salpingitis.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 study case report refers to a (b)(6) female patient, who was involved in an observational company-sponsored study, (b)(4).Patient had essure (fallopian tube occlusion insert) inserted and experienced fallopian tube inflammation (infection).This event, seen as salpingitis, is serious due medical importance and listed in the reference safety information for essure.Salpingitis occurs when microorganisms ascend from the lower genital tract, infecting the fallopian tubes.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections, including salpingitis after insertion procedure (within 4 weeks).In this case, limited information was provided.Apparently, the inflammation occurred two years after insertion and it was not related to insertion procedure.However due to lack of plausible alternative explanation and considering local action of essure in the fallopian tubes, causality with suspect device use cannot be totally excluded.Since this event led to salpingectomy, this case is regarded as incident.According to technical analysis, there is no reason to suspect a causal relationship of the reported adverse events to a potential quality deficit.Despite follow-up attempt, no further information was obtained (patient was not seen again by the investigator).

Manufacturer Narrative

Follow up information received on 12-may-2016: in (b)(6) 2012, essure devices were removed by bilateral salpingectomy (onset date of this event was reported as 2011 and stop date as (b)(6) 2012).This procedure was performed due to allergy and inflammation caused by essure, the investigator considered the event as related to essure devices and patient recovered from it in (b)(6) 2012.Hospitalization was required for the removal.Follow-up received on 17-may-2016: clarification received from investigator states that bilateral salpingectomy was deleted as event.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 19-may-2016 for the following meddra preferred term: salpingitis.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 pts.Company causality comment: this study case report refers to a (b)(6) female patient, who was involved in an observational company-sponsored study, study (b)(4).The patient had essure (fallopian tube occlusion insert) inserted and experienced fallopian tube inflammation (infection).She had the device removed by bilateral salpingectomy (approximatelly 3 years after its placement).These events are listed in the reference safety information for essure.Salpingitis occurs when microorganisms ascend from the lower genital tract, infecting the fallopian tubes.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections, including salpingitis after insertion procedure (within 4 weeks).In this case, apparently, the inflammation occurred two years after insertion and it was not related to insertion procedure.However due to lack of plausible alternative explanation and considering local action of essure in the fallopian tubes, causality with suspect device use cannot be totally excluded.Since this event led to salpingectomy, this case is regarded as incident.According to technical analysis, there is no reason to suspect a causal relationship of the reported adverse events to a potential quality deficit.

Manufacturer Narrative

Follow-up information received on 13-jun-2016.Quality-safety evaluation of ptc: ptc global number (b)(4).No sample returned for this investigation.None of the events mentioned on the complaint as reported can be related to a device quality defect.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.There was no event reported which indicates a new technical failure mode for the device a ptc investigation cannot be performed as no batch number or sample provided thus resulting in an unconfirmed quality defect.Device similar case listing 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 (b)(6)2016 for the following meddra preferred terms: salpingitis: the analysis in the global safety database revealed 35 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 these meddra pt.Company causality comment: this study case report refers to a (b)(6) female patient, who was involved in an observational company-sponsored study, study enquete success ii.The patient had essure (fallopian tube occlusion insert) inserted and experienced fallopian tube inflammation (infection).She had the device removed by bilateral salpingectomy (approximately 3 years after its placement) these events are listed in the reference safety information for essure.Salpingitis occurs when microorganisms ascend from the lower genital tract, infecting the fallopian tubes.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections, including salpingitis after insertion procedure (within 4 weeks).In this case, apparently, the inflammation occurred two years after insertion and it was not related to insertion procedure.However due to lack of plausible alternative explanation and considering local action of essure in the fallopian tubes, causality with suspect device use cannot be totally excluded.Since this event led to salpingectomy, this case is regarded as incident.According to technical analysis, there is no reason to suspect a causal relationship of the reported adverse events to a potential quality deficit.

Manufacturer Narrative

Follow up 13-jun-2016: legal claim was received from lawyer on behalf of plaintiff.Shortly after undergoing the essure procedure, an hysterosalpingogram test was performed on or around (b)(6) 2015, plaintiff was advised that her right essure coil had migrated out of her fallopian tube and into her abdominal cavity.Consequently, her post procedure period has been marked by increasingly severe pain and discomfort, including chronic back pain.She has never experienced any of these conditions prior to undergoing the essure procedure.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 she experienced severe abdominal pain/ severe pain.Essure coil migrated to abdominal cavity and was removed via laparoscopy 3 months after insertion.Pain and essure in abdominal cavity are serious events due to medical importance and listed in the reference safety information for essure.In this particular case, patient had severe abdominal pain and essure was found in abdominal cavity, in omentum adipose tissue.Her abdominal pain resolved after surgery (dechallenge positive).So, events are considered related to essure.This case was regarded as incident since a laparoscopy surgery to remove essure from abdomen was needed due to severe pain.The product technical analysis concluded unconfirmed quality defect.Based on the limited available information, there is no relationship between the reported medical event 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: 4894251
• MDR Text Key: 6834778
• Report Number: 2951250-2015-00465
• 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,Study,Health Professional,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• 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: 27 YR