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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); No Pressure (2994)

Patient Problems Abdominal Pain (1685); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("device migration") and genital haemorrhage ("heavy and abnormal bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with abdominal pain, genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain"), menometrorrhagia ("irregular and prolonged menstruation"), dyspareunia ("pain during intercourse") and migraine ("severe migraines").The patient was treated with surgery (hysterectomy to remove the essure device).Essure was removed.At the time of the report, the device dislocation, genital haemorrhage, dysmenorrhoea, menometrorrhagia, dyspareunia and migraine outcome was unknown.The reporter considered device dislocation, dysmenorrhoea, dyspareunia, genital haemorrhage, menometrorrhagia and migraine to be related to essure.Diagnostic results: plaintiff underwent an hsg (hysterosalpingogram) test, during which it was confirmed that plaintiff's essure coils were properly in place and that her fallopian tubes were occluded.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 dislocation ("device migration") and genital haemorrhage ("heavy and abnormal bleeding/unusual bleeding,") in a 35-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included endoscopy.Concomitant products included bromocriptine since (b)(6) 2011, cabergoline and medroxyprogesterone acetate (depo-provera).In 2014, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain"), menometrorrhagia ("irregular and prolonged menstruation"), dyspareunia ("pain during intercourse"), abdominal pain ("abdominal pain"), migraine ("severe migraines"), menstrual disorder ("unusual menstrual cycle,"), back pain ("back pain,"), pelvic pain ("pelvic pain,"), musculoskeletal pain ("shoulder pain"), neck pain ("neck pain") and headache ("headaches,").The patient was treated with surgery (hysterectomy to remove the essure device).Essure was removed on (b)(6) 2014.At the time of the report, the device dislocation, dysmenorrhoea, menometrorrhagia, migraine and musculoskeletal pain outcome was unknown and the genital haemorrhage, dyspareunia, abdominal pain, menstrual disorder, back pain, pelvic pain, neck pain and headache had resolved.The reporter considered abdominal pain, back pain, device dislocation, dysmenorrhoea, dyspareunia, genital haemorrhage, headache, menometrorrhagia, menstrual disorder, migraine, musculoskeletal pain, neck pain and pelvic pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 86.18 kgs.Plaintiff underwent an hsg (hysterosalpingogram) test, during which it was confirmed that plaintiff's essure coils were properly in place and that her fallopian tubes were occluded.Most recent follow-up information incorporated above includes: on 27-jun-2018: plaintiff fact sheet and mr received, new reporter, patient demographic information, patient relevant information essure indication , start stop date and event unusual menstrual cycle, back pain, pelvic pain, shoulder pain, neck pain and headaches were added 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.

• 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: 7198670
• MDR Text Key: 97474482
• Report Number: 2951250-2018-00431
• 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,other
• Type of Report: Initial,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BROMOCRIPTINE; CABERGOLINE; DEPO-PROVERA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 86