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

Catalog Number ESS305

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

Patient Problems Cyst(s) (1800); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

This case was reported via regulatory authority us food and drug administration (case # mw5067764) on 24-feb-2017 and was forwarded to bayer on 24-feb-2017.This spontaneous case was reported by a physician and describes the occurrence of device dislocation ("essure coil was visualized anterior to liver"), haemorrhagic ovarian cyst ("bleeding from right ovarian cyst") and peritoneal haemorrhage ("hemoperitoneum") in a female patient who received essure.On an unknown date, the patient started essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required), haemorrhagic ovarian cyst (seriousness criterion medically significant) and peritoneal haemorrhage (seriousness criterion medically significant).The patient was treated with surgery (surgery to remove device).At the time of the report, the device dislocation, haemorrhagic ovarian cyst and peritoneal haemorrhage outcome was unknown.The reporter provided no causality assessment for device dislocation, haemorrhagic ovarian cyst and peritoneal haemorrhage with essure.The reporter commented: patient with hemoperitoneum and surgical abdomen; presumed to be related to fallopian tube perforation of essure coil which was seen in left anterior peritoneum on pre-operative ct scan.At the time of surgery, coil could not be located due to large amount of blood.However, fallopian tube did not appear to be perforated or bleeding.Bleeding was noted from right ovarian cyst.On ct scan, essure coil was visualized anterior to liver.Contralateral coil was removed and sent to pathology with tube.Diagnostic results (normal ranges are provided in parenthesis if available): on an unknown date: computerised tomogram result was coils seen in left anterior peritoneum.On an unknown date: computerised tomogram result was coil visualized anterior to liver.Company causality comment: this spontaneous, medically confirmed case refers to a patient who had essure inserted and on unknown date, presented with hemoperitoneum (peritoneal haemorrhage), presumed to be related to fallopian tube perforation of essure coil which was seen in left anterior peritoneum on pre-operative ct scan.At the time of surgery, coil could not be located due to large amount of blood.However, fallopian tube did not appear to be perforated or bleeding.Bleeding was noted from right ovarian cyst (haemorrhagic ovarian cyst).On ct scan, essure coil was visualized anterior to liver (device dislocation).Contralateral coil was removed.Device dislocation is anticipated while hemorrhagic ovarian cyst and peritoneal haemorrhage are unanticipated in the reference safety information for essure.The exact time point and mechanism of device dislocation are not known, however, considering the event's nature, causality with essure cannot be excluded.Ovarian cysts are a common occurrence in women of reproductive age.Each month, a mature ovarian follicle ruptures, occasionally, these follicle may bleed into the ovary becoming hemorrhagic.Considering the ovarian cysts pathophysiology, a causal relationship with essure can be excluded.Also peritoneal haemorrhage was considered unrelated to essure.This case was regarded as incident as a surgical procedure was required.A product technical analysis and further information are 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 meddra llt can be provided.Most recent follow-up information incorporated above includes: on 20-mar-2017: quality-safety evaluation of ptc was received.Company causality comment: this spontaneous, medically confirmed case refers to a patient who had essure inserted and on unknown date, presented with hemoperitoneum (peritoneal haemorrhage), presumed to be related to fallopian tube perforation of essure coil which was seen in left anterior peritoneum on pre-operative ct scan.At the time of surgery, coil could not be located due to large amount of blood.However, fallopian tube did not appear to be perforated or bleeding.Bleeding was noted from right ovarian cyst (haemorrhagic ovarian cyst).On ct scan, essure coil was visualized anterior to liver (device dislocation).Contralateral coil was removed.Device dislocation is anticipated while hemorrhagic ovarian cyst and peritoneal haemorrhage are unanticipated in the reference safety information for essure.The exact time point and mechanism of device dislocation are not known, however, considering the event's nature, causality with essure cannot be excluded.Ovarian cysts are a common occurrence in women of reproductive age.Each month, a mature ovarian follicle ruptures, occasionally, these follicle may bleed into the ovary becoming hemorrhagic.Considering the ovarian cysts pathophysiology, a causal relationship with essure can be excluded.Also peritoneal haemorrhage was considered unrelated to essure.This case was regarded as incident as a surgical procedure was required.A product quality defect could not be confirmed but is considered plausible.Further information is expected.

• 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: 6417757
• MDR Text Key: 70406965
• Report Number: 2951250-2017-00932
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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 Catalogue Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• 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