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

Model Number ESS305

Device Problems Folded (2630); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 10/03/2011

Event Type  Injury  

Event Description

This study case report was received from an investigator in (b)(6) on (b)(6) 2010 and refers to a (b)(6)-year-old female patient who was involved in an observational company-sponsored study, study number: (b)(6).Additional information was received on (b)(6) 2011 which qualifies this case as an incident.Study description: study (b)(6), essure ess305 is a non-interventional, multicenter, prospective, epidemiological study with the aim to determine the rate of predictive factors for successful bilateral placement and the final efficacy of the essure® permanent sterilization method, as measured by the absence of pregnancy.Patient number: (b)(6).Patient had no relevant medical history and used hormonal iud as current contraception.The date of her last menstrual period was (b)(6) 2010.Essure was inserted.No anesthesia was applied during procedure, uterine distension was done and hysteroscopy was possible.Patient's uterine cavity examination was normal and her uterus was not retroverted.Physician started the insertion on left side and informed it was easy to introduce the catheter into both tubes and the placement was successful (externally visible coil in the uterine cavity: 1 on both sides).Procedure took 6 minutes.Patient experienced pain during passage through the cervix and during essure placement in both tubes.She did not present pain after procedure or vasovagal syncope.No other procedure was performed at the same time of insertion.Patient did not take post-operative analgesics and did not use contraceptive methods during the 3 months post essure placement.She did not experience pain/cramping but experienced bleeding/metrorrhagias.On (b)(6) 2011, a pelvic ultrasound (2d) was performed and showed good insert position on right side but left insert was not seen from the cavity to horn (doubtful insert position).Essure in left side was folded in uterine cavity.An outpatient hysteroscopy showed left essure insert was exteriorized with more than 8 coils inside the cavity.Hysteroscopy and celioscopy were performed and left essure insert was withdrawn; a clip was placed in left fallopian tube.Ptc investigation result was received on (b)(6) 2015.This adverse event report is related to a product technical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 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)(4).In this particular case a search in the database was performed on (b)(6) 2015 for the following (b)(4) preferred term: device dislocation.The analysis in the global safety database revealed 322 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)(4) pt.Company causality comment: this medically confirmed, study case report refers to a (b)(6)-year-old female patient who was involved in an observational company-sponsored study.She had essure (fallopian tube occlusion insert) inserted and at control examination, essure in left side was folded in uterine cavity and exteriorized with more than 8 coils inside the uterine cavity.This device was withdrawn by hysteroscopy and celioscopy.The reported event, regarded as device dislocation, is listed according to essure's reference safety information and was considered serious due to medical importance.During essure micro-insert 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, although the exact mechanism of the reported dislocation is unknown, given its nature; causality with the suspect device cannot be excluded.Since a celioscopy was performed, this case was regarded as incident.A product technical analysis was performed and concluded 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 22-jun-2016: (b)(4).Essure was inserted on (b)(6) 2010, lot number 20218448.At the reporting time, essure on right side was ongoing.In (b)(6) 2010, ultrasound showed left essure insert partly in uterine cavity.On (b)(6) 2011, essure of left side was removed via hysteroscopy and placement of filshie clip was performed on left side.The event "migration of left essure insert" was reported non serious by investigator and considered unrelated to the devices.Company causality comment this medically confirmed, study case report refers to a (b)(6) female patient who was involved in an (b)(6) study.She had essure (fallopian tube occlusion insert) inserted and at control examination, essure in left side was folded in uterine cavity and exteriorized with more than 8 coils inside the uterine cavity.Upon receipt of follow-up, this event was updated to migration of left essure insert.This device was withdrawn by hysteroscopy, celioscopy and placement of filshie clip was performed on left side.The reported event, regarded as device dislocation, is listed according to essure's reference safety information and was considered serious due to medical importance.During essure micro-insert 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, although the exact mechanism of the reported dislocation is unknown, given its nature; causality with the suspect device cannot be excluded.This case was regarded as incident since surgical intervention was performed.A product technical analysis was performed and concluded there is no reason to suspect a causal relationship of the reported adverse events to a potential quality deficit.Since batch number was provided, an updated ptc is expected.

Manufacturer Narrative

Follow-up information received from the physician on 18-jul-2016: it was confirmed that "left essure insert was folded in uterine cavity" and "migration of left essure insert" were the same event and only event "migration of left essure insert" should be kept.It was confirmed that event "migration of left essure insert" was considered as a migration and not as an expulsion.Follow-up information received on 08-aug-2016: update of quality-safety evaluation of ptc.The bayer reference number for the ptc report is: (b)(4).Lot number: 20218448 manufacturing date: oct-2009 expiration date: oct-2012.No sample available for this investigation.We conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known, possible undesirable events and not indicative of a quality deficit per se.No similar ae case reports have been received to date in relation to the reported batch.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 09-aug-2016 for the following meddra preferred term: device dislocation.The analysis in the global safety database revealed 667 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 medically confirmed, study case report refers to a (b)(6) female patient who was involved in an observational company-sponsored study.She had essure (fallopian tube occlusion insert) inserted and at control examination, there was migration of left essure insert (previously reported as essure in left side was folded in uterine cavity and exteriorized with more than 8 coils inside the uterine cavity).This device was withdrawn by hysteroscopy, celioscopy and placement of filshie clip was performed on left side.The reported event, regarded as device migration/dislocation, is listed according to essure's reference safety information and was considered serious due to medical importance.During essure micro-insert therapy there is a risk that the device could move within the fallopian tubes to a proximal fallopian tube location.In this particular case, although the exact onset date of this migration is unknown, given its nature; causality with the suspect device cannot be excluded.This case was regarded as incident since surgical intervention was required.According to product technical analysis, a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.No similar ae case reports have been received to date in relation to the reported batch.No further information is expected.

Manufacturer Narrative

Follow-up information received on 30-aug-2016 and 31-aug-2016.In (b)(6) 2010 she experienced metrorrhagia.On (b)(6) 2011 she recovered from it.Ambulatory hysteroscopy was performed on (b)(6) 2011: left essure was very stretched with several abnormal outer and inner coils in the uterine cavity.Left essure was removed with no problem via hysteroscopy.Celioscopy was performed to place filshie clip at 2 cm of the uterine horn.It was confirmed that migration of left essure insert and intra cavitary left essure were the same event and the start date of the event was (b)(6) 2011.Event migration of left essure insert changed to intra cavitary left essure.The investigator considered the event intra cavitary left essure as serious due to hospitalization and metrorrhagia as non-serious.The patient was discharged on (b)(6) 2011.The events intra cavitary left essure and metrorrhagia were considered related to essure.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 01-sep-2016 for the following meddra preferred term: device dislocation.The analysis in the global safety database revealed 716 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 medically confirmed, study case report refers to a female patient who was involved in an observational company-sponsored study.She had essure (fallopian tube occlusion insert) inserted and it was reported the occurrence of intra cavitary left essure (previously reported as migration of left essure insert).This device was withdrawn by hysteroscopy, celioscopy and placement of filshie clip was performed on left side.The investigator considered this event as related to essure.The reported event, regarded as device migration/dislocation, is listed according to essure's reference safety information and was considered serious due to hospitalization.During essure micro-insert therapy there is a risk that the device could move within the fallopian tubes to a proximal fallopian tube location.In this particular case, although the exact onset date of this migration is unknown, given its nature; causality with the suspect device cannot be excluded.This case was regarded as incident since surgical intervention was required.According to product technical analysis, a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.No similar ae case reports have been received to date in relation to the reported batch.No further information is expected.

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: 4895499
• MDR Text Key: 6069067
• Report Number: 2951250-2015-00471
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2012
• Device Model Number: ESS305
• Device Lot Number: 20218448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2010
• Initial Date FDA Received: 07/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/18/2016; 08/15/2016; 09/27/2016; 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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: 47 YR