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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hemorrhage/Bleeding (1888); Depression (2361)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("one coil could not be located") and genital haemorrhage ("heavy bleeding ") in a female patient who received essure for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient started essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required) with abdominal pain, genital haemorrhage (seriousness criterion medically significant), depression ("depression"), fatigue ("fatigue") and device difficult to use ("during removal procedure, only one essure coil was removed").The patient was treated with surgery (only one essure coil removed, as well as uterus and fallopian tubes on (b)(6) 2011).Essure was withdrawn.At the time of the report, the device dislocation, genital haemorrhage, depression and fatigue outcome was unknown and the device difficult to use outcome was unknown.The reporter considered device dislocation, genital haemorrhage, depression, fatigue and device difficult to use to be related to essure.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced heavy bleeding (seen as genital bleeding).Approximately 18 months after insertion, during a hysterectomy procedure, one coil could not be located (seen as a device dislocation) and thus only one coil was removed.These both reported events are anticipated in the reference safety information for essure.Changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.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 or out of the body; or a device dislocation into the fallopian tube or into abdominal cavity.In this present case, the exact time point of dislocation is unknown.Therefore, given the nature of these events, it was considered related to essure.This case was regarded as incident since intervention was required (device removal was required).Other nonserious events were reported.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.

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 meddra llt can be provided.Most recent follow-up information incorporated above includes: on 7-feb-2017: quality-safety evaluation of ptc.Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced heavy bleeding (seen as genital bleeding).Approximately 18 months after insertion, during a hysterectomy procedure, one coil could not be located (seen as a device dislocation) and thus only one coil was removed.These both reported events are anticipated in the reference safety information for essure.Changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.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 or out of the body; or a device dislocation into the fallopian tube or into abdominal cavity.In this present case, the exact time point of dislocation is unknown.Therefore, given the nature of these events, it was considered related to essure.This case was regarded as incident since intervention was required (device removal was required).Other nonserious events were reported.A product technical analysis resulted in an unconfirmed but plausible product quality defect and a relationship with the reported medical events cannot be totally excluded.No active follow-up is allowed and further information is expected only through litigation process.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• 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: 6276138
• MDR Text Key: 65705097
• Report Number: 2951250-2017-00285
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• 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