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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Abscess (1690); Cyst(s) (1800); Internal Organ Perforation (1987); Injury (2348)

Event Date 09/26/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of tubo-ovarian abscess ("right tubal ovarian abscess"), the first episode of device dislocation ("the appendix confirmed a coil"), gastrointestinal injury ("the appendix confirmed a coil"), appendicitis ("secondary appendicitis"), ovarian cyst ("left upper quadrant pain and left ovarian cyst") and the second episode of device dislocation ("no essure was found/hcp was not able to locate the other essure") in a (b)(6)-year-old female patient who received essure for female sterilisation.In (b)(6) 2011, the patient started essure.On (b)(6) 2016, the patient experienced tubo-ovarian abscess (seriousness criteria medically significant and clinically significant/intervention required), the first episode of device dislocation (seriousness criterion medically significant), gastrointestinal injury (seriousness criterion medically significant) and appendicitis (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced ovarian cyst (seriousness criterion medically significant) with abdominal pain upper.On (b)(6) 2017, the patient experienced the second episode of device dislocation (seriousness criterion medically significant).The patient was treated with surgery (surgery to remove) and surgery.At the time of the report, the tubo-ovarian abscess, first episode of device dislocation, gastrointestinal injury, appendicitis, ovarian cyst and second episode of device dislocation outcome was unknown.The reporter provided no causality assessment for tubo-ovarian abscess, the first episode of device dislocation, gastrointestinal injury, appendicitis, ovarian cyst and the second episode of device dislocation with essure.Diagnostic results: on (b)(6) 2016 the patient went to the er (emergency room) and it looked like a right tubal ovarian abscess and second appendicitis.On (b)(6) 2016 the appendix confirmed a coil of 10.5 cm.On (b)(6) 2016 the patient went to er again and what was noted was left upper quadrant pain and left ovarian cyst.Company causality comment: this spontaneous case report refers to a (b)(6) year-old female consumer who had essure (fallopian tube occlusion inserts) inserted and, approximately 5 years after insertion, she experienced right tubal ovarian abscess, the appendix confirmed a coil (seen as device dislocation and traumatic perforation of bowel) and she had appendicitis.Three months later, she started to experience upper quadrant pain and the diagnosis was an ovarian cyst on left ovary.Approximately one month after ovarian cyst diagnosis, during a surgery to remove this cyst, left essure coil was not found (seen as device dislocation).Tubal-ovarian abscess, traumatic perforation of bowel, and device dislocation are anticipated in the reference safety information for essure while appendicitis and ovarian cyst are unanticipated.During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus, out of the body; or a device dislocation into the fallopian tube or into abdominal cavity.Thus, based on the nature of this event, device dislocation was considered related to essure.As the events right tubal ovarian abscess, the appendix confirmed a coil, and appendicitis were seen as complications of the dislocation, they were also assessed as related to essure use.There are various types of ovarian cysts; however, functional cysts are the most common type.Based on essure method of action and on the physiopathology of an ovarian cyst, the causality for the event ovarian cyst was assessed as unrelated to essure use.This case was regarded as incident since intervention was required.Other nonserious events were reported.A product technical analysis is being sought.Further information is expected.

Manufacturer Narrative

Quality-safety evaluation of ptc: sample not available.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.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 not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on (b)(6) 2017: quality safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a (b)(6)-year-old female consumer who had essure (fallopian tube occlusion inserts) inserted and, approximately 5 years after insertion, she experienced right tubal ovarian abscess, the appendix confirmed a coil (seen as device dislocation and traumatic perforation of bowel) and she had appendicitis.Three months later, she started to experience upper quadrant pain and the diagnosis was an ovarian cyst on left ovary.Approximately one month after ovarian cyst diagnosis, during a surgery to remove this cyst, left essure coil was not found (seen as device dislocation).Tubal-ovarian abscess, traumatic perforation of bowel, and device dislocation are anticipated in the reference safety information for essure while appendicitis and ovarian cyst are unanticipated.During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus, out of the body; or a device dislocation into the fallopian tube or into abdominal cavity.Thus, based on the nature of this event, device dislocation was considered related to essure.As the events right tubal ovarian abscess, the appendix confirmed a coil, and appendicitis were seen as complications of the dislocation, they were also assessed as related to essure use.There are various types of ovarian cysts; however, functional cysts are the most common type.Based on essure method of action and on the physiopathology of an ovarian cyst, the causality for the event ovarian cyst was assessed as unrelated to essure use.This case was regarded as incident since intervention was required.Other nonserious events were reported.The product technical analysis resulted in an unconfirmed but plausible product quality defect and a relationship with the reported medical events cannot be totally excluded.Further information is expected.

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of tubo-ovarian abscess ("right tubal ovarian abscess"), the first episode of device dislocation ("the appendix confirmed a coil"), gastrointestinal injury ("the appendix confirmed a coil"), appendicitis ("secondary appendicitis"), ovarian cyst ("left upper quadrant pain and left ovarian cyst") and the second episode of device dislocation ("no essure was found/hcp was not able to locate the other essure") in a (b)(6)-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2011, the patient had essure inserted.On (b)(6) 2016, the patient experienced tubo-ovarian abscess (seriousness criteria medically significant and intervention required), the first episode of device dislocation (seriousness criteria medically significant and intervention required), gastrointestinal injury (seriousness criteria medically significant and intervention required) and appendicitis (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced ovarian cyst (seriousness criterion medically significant) with abdominal pain upper.On (b)(6) 2017, the patient experienced the second episode of device dislocation (seriousness criterion medically significant).On an unknown date, the patient experienced device difficult to use ("patient wanted to have the other essure removed but hcp was not able to locate it").The patient was treated with surgery (surgery to remove) and surgery.At the time of the report, the tubo-ovarian abscess, gastrointestinal injury, appendicitis, ovarian cyst and the last episode of device dislocation outcome was unknown and the device difficult to use had not resolved.The reporter provided no causality assessment for appendicitis, device difficult to use, gastrointestinal injury, ovarian cyst, tubo-ovarian abscess, the first episode of device dislocation and the second episode of device dislocation with essure.Diagnostic results: on (b)(6) 2016 the patient went to the er (emergency room) and it looked like a right tubal ovarian abscess and second appendicitis.On (b)(6) 2016 the appendix confirmed a coil of 10.5 cm.On (b)(6) 2016 the patient went to er again and what was noted was left upper quadrant pain and left ovarian cyst.Quality-safety evaluation of ptc: sample not available.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.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 not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on (b)(6) 2017: reporter did not respond to final follow up attempt.Company causality comment: this spontaneous case report refers to a (b)(6)-year-old female consumer who had essure (fallopian tube occlusion inserts) inserted and, approximately 5 years after insertion, experienced right tubal ovarian abscess, the appendix confirmed a coil (seen as device dislocation and traumatic perforation of bowel) and had appendicitis.Three months later, she started to experience upper quadrant pain and the diagnosis was an ovarian cyst on left ovary.Approximately one month later, during surgery to remove the cyst, left essure coil was not found (seen as device dislocation).Tubal-ovarian abscess, traumatic perforation of bowel, and device dislocation are anticipated in the reference safety information for essure while appendicitis and ovarian cyst are unanticipated.During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus, out of the body; or a device dislocation into the fallopian tube or into abdominal cavity.Thus, based on the nature of this event, device dislocation was considered related to essure.As the events right tubal ovarian abscess, the appendix confirmed a coil, and appendicitis were seen as complications of the dislocation, they were also assessed as related to essure use.There are various types of ovarian cysts; however, functional cysts are the most common type.Based on essure method of action and on the physiopathology of an ovarian cyst, the causality for the event ovarian cyst was assessed as unrelated to essure use.This case was regarded as incident since intervention was required.Other nonserious events were reported.The product technical analysis resulted in an unconfirmed but plausible product quality defect.No further information could be obtained.

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of tubo-ovarian abscess ("right tubal ovarian abscess"), the first episode of device dislocation ("the appendix confirmed a coil"), gastrointestinal injury ("the appendix confirmed a coil"), appendicitis ("secondary appendicitis"), ovarian cyst ("left upper quadrant pain and left ovarian cyst") and the second episode of device dislocation ("no essure was found/hcp was not able to locate the other essure") in a (b)(6) year-old female patient who had essure inserted for female sterilisation.Other product or product use issues identified: device difficult to use "patient wanted to have the other essure removed but hcp was not able to locate it".In (b)(6) 2011, the patient had essure inserted.On (b)(6) 2016, the patient experienced tubo-ovarian abscess (seriousness criteria medically significant and intervention required), the first episode of device dislocation (seriousness criteria medically significant and intervention required), gastrointestinal injury (seriousness criteria medically significant and intervention required) and appendicitis (seriousness criteria medically significant and intervention required).On (b)(6) 2016, the patient experienced ovarian cyst (seriousness criterion medically significant) with abdominal pain upper.On (b)(6) 2017, the patient experienced the second episode of device dislocation (seriousness criterion medically significant).The patient was treated with surgery (surgery to remove) and surgery.At the time of the report, the tubo-ovarian abscess, gastrointestinal injury, appendicitis, ovarian cyst and the last episode of device dislocation outcome was unknown.The reporter provided no causality assessment for appendicitis, gastrointestinal injury, ovarian cyst, tubo-ovarian abscess, the first episode of device dislocation and the second episode of device dislocation with essure.Diagnostic results: on (b)(6) 2016 the patient went to the er (emergency room) and it looked like a right tubal ovarian abscess and second appendicitis.On (b)(6) 2016 the appendix confirmed a coil of 10.5 cm.On (b)(6) 2016 the patient went to er again and what was noted was left upper quadrant pain and left ovarian cyst.Quality-safety evaluation of ptc: sample not available.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.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 not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no med dra llt can be provided.Most recent follow-up information incorporated above includes: on 22-mar-2018: this case was found to be a duplicate of case (b)(4) and will be deleted from bayer database.All information was transferred to the remaining case.This spontaneous case report refers to a (b)(6) year-old female consumer who had essure (fallopian tube occlusion inserts) inserted and, approximately 5 years after insertion, experienced right tubal ovarian abscess, the appendix confirmed a coil (seen as device dislocation and traumatic perforation of bowel) and had appendicitis.Three months later, she started to experience upper quadrant pain and the diagnosis was an ovarian cyst on left ovary.Approximately one month later, during surgery to remove the cyst, left essure coil was not found (seen as device dislocation).Tubal-ovarian abscess, traumatic perforation of bowel, and device dislocation are anticipated in the reference safety information for essure while appendicitis and ovarian cyst are unanticipated.During essure micro-insert therapy, there is a risk that the device could move out of the fallopian tubes.This movement could be a device expulsion into the uterus, out of the body; or a device dislocation into the fallopian tube or into abdominal cavity.Thus, based on the nature of this event, device dislocation was considered related to essure.As the events right tubal ovarian abscess, the appendix confirmed a coil, and appendicitis were seen as complications of the dislocation, they were also assessed as related to essure use.There are various types of ovarian cysts; however, functional cysts are the most common type.Based on essure method of action and on the physiopathology of an ovarian cyst, the causality for the event ovarian cyst was assessed as unrelated to essure use.This case was regarded as incident since intervention was required.Other nonserious events were reported.The product technical analysis resulted in an unconfirmed but plausible product quality defect.No further information could be obtained.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6276352
• MDR Text Key: 65712607
• Report Number: 2951250-2017-00295
• 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: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/22/2018
• Supplement Dates FDA Received: 03/03/2017; 05/05/2017; 03/22/2018
• 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: 45 YR