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

Model Number ESS305

Device Problems Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Hair Loss (1877); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994)

Event Date 05/01/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.In (b)(6) 2016, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), alopecia ("hair loss"), dysmenorrhoea ("painful menstrual cycles"), vaginal haemorrhage ("heavy vaginal bleeding"), dyspareunia ("painful intercourse"), abdominal pain ("abdominal pain") and infection ("infection").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, alopecia, dysmenorrhoea, vaginal haemorrhage, dyspareunia, abdominal pain and infection outcome was unknown.The reporter considered abdominal pain, alopecia, dysmenorrhoea, dyspareunia, infection, pelvic pain and vaginal haemorrhage 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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure (batch no.D19661) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful menstrual cycles") and abdominal pain ("abdominal pain").On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced dyspareunia ("painful intercourse").On an unknown date, the patient experienced alopecia ("hair loss"), vaginal haemorrhage ("heavy vaginal bleeding"), infection ("infection") and menorrhagia ("menorrhagiaabnormal bleeding (vaginal, menorrhagia)").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, alopecia, dysmenorrhoea, vaginal haemorrhage, dyspareunia, abdominal pain, infection and menorrhagia outcome was unknown.The reporter considered abdominal pain, alopecia, dysmenorrhoea, dyspareunia, infection, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure in left tube failed to separate from the introducer and pulled mostly out of the tube.Was able to remove it completely.Placed a second device, deployed normally.Most recent follow-up information incorporated above includes: on 4-apr-2018: pfs was received.Event menorrhagia was added.Lot number added.Product, patient & reporter information updated.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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure (batch no.D19661, udi no.((b)(4).Inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6)2016, the patient had essure inserted.In may 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful menstrual cycles") and abdominal pain ("abdominal pain").In june 2016, the patient experienced dyspareunia ("painful intercourse").On an unknown date, the patient experienced alopecia ("hair loss"), vaginal haemorrhage ("heavy vaginal bleeding"), infection ("infection") and menorrhagia ("menorrhagiaabnormal bleeding (vaginal, menorrhagia)").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, alopecia, dysmenorrhoea, vaginal haemorrhage, dyspareunia, abdominal pain, infection and menorrhagia outcome was unknown.The reporter considered abdominal pain, alopecia, dysmenorrhoea, dyspareunia, infection, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure in left tube failed to separate from the introducer and pulled mostly out of the tube.Was able to remove it completely.Placed a second device, deployed normally 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~ we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure (batch no.D19661) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful menstrual cycles") and abdominal pain ("abdominal pain").On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced dyspareunia ("painful intercourse").On an unknown date, the patient experienced alopecia ("hair loss"), vaginal haemorrhage ("heavy vaginal bleeding"), infection ("infection") and menorrhagia ("menorrhagia abnormal bleeding (vaginal, menorrhagia)").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, alopecia, dysmenorrhoea, vaginal haemorrhage, dyspareunia, abdominal pain, infection and menorrhagia outcome was unknown.The reporter considered abdominal pain, alopecia, dysmenorrhoea, dyspareunia, infection, menorrhagia, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: essure in left tube failed to separate from the introducer and pulled mostly out of the tube.Was able to remove it completely.Placed a second device, deployed normally.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-aug-2018: quality-safety evaluation of product technical complaint update.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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.D19661, udi no.(b)(4) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2016, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dysmenorrhoea ("painful menstrual cycles") and abdominal pain ("abdominal pain").In (b)(6) 2016, the patient experienced dyspareunia ("painful intercourse").On an unknown date, the patient experienced alopecia ("hair loss"), vaginal haemorrhage ("heavy vaginal bleeding"), menorrhagia ("menorrhagiaabnormal bleeding (vaginal, menorrhagia)"), vaginal infection ("vaginal infection"), bladder disorder ("bladder/urinary problems") and urinary tract disorder ("bladder/urinary problems").The patient was treated with surgery (laparoscopically assisted vaginal hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, alopecia, dysmenorrhoea, vaginal haemorrhage, dyspareunia, abdominal pain, menorrhagia, vaginal infection, bladder disorder and urinary tract disorder outcome was unknown.The reporter considered abdominal pain, alopecia, bladder disorder, dysmenorrhoea, dyspareunia, menorrhagia, pelvic pain, urinary tract disorder, vaginal haemorrhage and vaginal infection to be related to essure.The reporter commented: essure in left tube failed to separate from the introducer and pulled mostly out of the tube.Was able to remove it completely.Placed a second device, deployed normally.Plantiff received treatment for dysmennorhea (cramping),dyspareunia (painful sexual intercourse),pelvic pain, abdominal pain, and menorrhagia (heavy menstrual bleeding).Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: plaintiff fact sheet received- new events bladder/urinary problems, vaginal infection were added.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary 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: 7110143
• MDR Text Key: 94631412
• Report Number: 2951250-2017-10654
• 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,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: ESS305
• Device Lot Number: D19661
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 25 YR