MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Occlusion Within Device (1423); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 07/16/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("device had migrated from its location") in a female patient who had essure inserted for female sterilisation.On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (laparoscopic tubal occlusion with falope rings hysteroscopy).At the time of the report, the device dislocation outcome was unknown.The reporter considered device dislocation to be related to essure.The reporter commented: plaintiff underwent laparoscopic tubal occlusion with falope rings, hysteroscopy due to complications from the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: confirmed that essure was successfully occluded.Most recent follow-up information incorporated above includes: on (b)(6) 2017: plaintiff underwent laparoscopic tubal occlusion with falope rings hysteroscopy due to complications from the essure device.Action taken with drug updated with drug withdrawn.Incident.No lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("two essure devices lying in lower uterine segment.Procedure: in the internal os and in the lower uterine segment the two essure coils were lying") in a 42-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, 4 months 16 days after insertion of essure, the patient experienced device dislocation ("device had migrated from its location").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (hysteroscopy with removal of foreign body (essure x 2) from uterine cavity).Essure was removed on (b)(6) 2013.At the time of the report, the device expulsion and device dislocation outcome was unknown and the pelvic pain was resolving.The reporter considered device dislocation, device expulsion and pelvic pain to be related to essure.The reporter commented: plaintiff underwent laparoscopic tubal occlusion with fallop rings, hysteroscopy due to complications from the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: confirmed that essure was successfully occluded.Occluded l fallopian tube.Patent r fallopian tube essure filaments not seen in fallopian tubes.Essure filaments noted within the peritoneal space.¿concerning the injuries reported in this case, the following one was described in patient¿s medical record: device expulsion, device dislocation most recent follow-up information incorporated above includes: on 2-mar-2018: plaintiff fact sheet & medical record received.Event device expulsion was added.Patient, product & reporter information updated.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("two essure devices lying in lower uterine segment.Procedure: in the internal os and in the lower uterine segment the two essure coils were lying") and device dislocation ("device had migrated from its location / essure filaments not seen in fallopian tubes.Essure filaments noted within peritoneal space.") in a 42-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube" on (b)(6) 2013.Concomitant products included paracetamol (acetaminophen) since (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (hysteroscopy with removal of foreign body (essure x 2) from uterine cavity) and surgery (hysteroscopy with removal of foreign body (essure x 2) from uterine cavity).Essure was removed on (b)(6) 2013.At the time of the report, the device expulsion and device dislocation outcome was unknown and the pelvic pain was resolving.The reporter considered device dislocation, device expulsion and pelvic pain to be related to essure.The reporter commented: plaintiff underwent laparoscopic tubal occlusion with fallop rings, hysteroscopy due to complications from the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: confirmed that essure was successfully occluded.Occluded l fallopian tube.Patent r fallopian tube essure filaments not seen in fallopian tubes.Essure filaments noted within the peritoneal space.¿concerning the injuries reported in this case, the following one was described in patient¿s medical record: device expulsion, device dislocation most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Event failure to occlude (close) fallopian tube added.Lot number added.Incident was also considered for dislocation.Incident at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("two essure devices lying in lower uterine segment.Procedure: in the internal os and in the lower uterine segment the two essure coils were lying") and device dislocation ("device had migrated from its location / essure filaments not seen in fallopian tubes.Essure filaments noted within peritoneal space.") in a 42-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube" on (b)(6) 2013.Concomitant products included paracetamol (acetaminophen) since (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain ("pain"), depression ("depression") and anxiety ("mental anguish").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).The patient was treated with surgery (hysteroscopy with removal of foreign body (essure x 2) from uterine cavity) and surgery (hysteroscopy with removal of foreign body (essure x 2) from uterine cavity).Essure was removed on (b)(6) 2013.At the time of the report, the device expulsion, device dislocation, depression and anxiety outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, depression, device dislocation, device expulsion and pelvic pain to be related to essure.The reporter commented: plaintiff underwent laparoscopic tubal occlusion with fallop rings, hysteroscopy due to complications from the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: confirmed that essure was successfully occluded.Occluded l fallopian tube.Patent r fallopian tube essure filaments not seen in fallopian tubes.Essure filaments noted within the peritoneal space.¿concerning the injuries reported in this case, the following one was described in patient¿s medical record: device expulsion, device dislocation quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-sep-2018: quality-safety evaluation of product technical complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Ntaneous case was reported by a lawyer and describes the occurrence of device expulsion ("two essure devices lying in lower uterine segment.Procedure: in the internal os and in the lower uterine segment the two essure coils were lying") and device dislocation ("device had migrated from its location / essure filaments not seen in fallopian tubes.Essure filaments noted within peritoneal space.") in a 42-year-old female patient who had essure (batch no.A64629) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude (close) fallopian tube" on (b)(6) 2013.Concomitant products included paracetamol (acetaminophen) since (b)(6) 2013.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain ("pain"), depression ("depression") and anxiety ("mental anguish").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).The patient was treated with surgery (hysteroscopy with removal of foreign body (essure x 2) from uterine cavity).Essure was removed on (b)(6) 2013.At the time of the report, the device expulsion, device dislocation, depression and anxiety outcome was unknown and the pelvic pain was resolving.The reporter considered anxiety, depression, device dislocation, device expulsion and pelvic pain to be related to essure.The reporter commented: plaintiff underwent laparoscopic tubal occlusion with fallop rings, hysteroscopy due to complications from the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: confirmed that essure was successfully occluded.Occluded l fallopian tube.Patent r fallopian tube essure filaments not seen in fallopian tubes.Essure filaments noted within the peritoneal space.¿concerning the injuries reported in this case, the following one was described in patient¿s medical record: device expulsion, device dislocation.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Events added - depression and mental anguish.Events onset date added.Incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 6934897
• MDR Text Key: 89172302
• Report Number: 2951250-2017-04408
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: ESS305
• Device Lot Number: A64629
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACETAMINOPHEN; ACETAMINOPHEN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR