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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Migration or Expulsion of Device (1395); Insufficient Information (3190); Migration (4003)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration") and device breakage ("device fracture") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage and pelvic pain outcome was unknown.The reporter considered device breakage, device dislocation and pelvic pain to be related to essure.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

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration"), device breakage ("device fracture") and genital haemorrhage ("abnormal bleeding (general)") in a 36-year-old female patient who had essure (batch no.A20064) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's concurrent conditions included female sterilisation.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pain"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), device expulsion ("migration of essure device.Location of device: migration to uterus"), tooth disorder ("dental problems"), fatigue ("fatigue"), alopecia ("hair loss"), weight increased ("weight gain"), back pain ("lower back pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, genital haemorrhage, pelvic pain, bladder disorder, urinary tract disorder, device expulsion, tooth disorder, fatigue, alopecia and weight increased outcome was unknown and the back pain and abdominal pain had resolved.The reporter considered abdominal pain, alopecia, back pain, bladder disorder, device breakage, device dislocation, device expulsion, fatigue, genital haemorrhage, pelvic pain, tooth disorder, urinary tract disorder and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.7 kg/sqm.Most recent follow-up information incorporated above includes: on 18-jun-2018: pfs and medical record received: lot number, reporter information, patient details, other relevant history, product information and events : abnormal bleeding (general), bladder or urinary problems or changes, bladder or urinary problems or changes, migration of essuredevice.Location of device: migration to uterus, dental problems, fatigue, hair loss, weight gain, lower back pain, abdominal pain, plaintiff did not undergo essure confirmation test were 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.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration"), device breakage ("device fracture") and genital haemorrhage ("abnormal bleeding (general)") in a 36-year-old female patient who had essure (batch no.A20064) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's concurrent conditions included obesity.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pain"), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), device expulsion ("migration of essure device.Location of device: migration to uterus"), tooth disorder ("dental problems"), fatigue ("fatigue"), alopecia ("hair loss"), weight increased ("weight gain"), back pain ("lower back pain") and abdominal pain ("abdominal pain").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the device dislocation, device breakage, genital haemorrhage, pelvic pain, bladder disorder, urinary tract disorder, device expulsion, tooth disorder, fatigue, alopecia and weight increased outcome was unknown and the back pain and abdominal pain had resolved.The reporter considered abdominal pain, alopecia, back pain, bladder disorder, device breakage, device dislocation, device expulsion, fatigue, genital haemorrhage, pelvic pain, tooth disorder, urinary tract disorder and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 38.7 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc.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: 7056539
• MDR Text Key: 92870037
• Report Number: 2951250-2017-08339
• 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,Followup
• Report Date: 08/07/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: ESS305
• Device Lot Number: A20064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/18/2018; 07/30/2018
• Supplement Dates FDA Received: 07/13/2018; 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 109