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

Model Number ESS305

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

Patient Problems Pain (1994); Perforation (2001); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant"), device breakage ("fracturing of the implant") and perforation ("perforation of organs") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, 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), perforation (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) 2017.At the time of the report, the device dislocation, perforation and pelvic pain outcome was unknown.The reporter considered device breakage, device dislocation, pelvic pain and perforation 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 breakage ("fracturing of the implant/ the other fractured leaving a small piece by my uterus") and uterine perforation ("perforation (uterus)/ malposition of essure device location of device: uterine wall/migration of implant/ one device is stuck somewhere in my abdominal cavity") in a 31-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included dermoid cyst of ovary since (b)(6) 2016, hypermobility syndrome since (b)(6) 2016, breast abscess since (b)(6) 2016, ovarian torsion since (b)(6) 2016, undifferentiated connective tissue disease since (b)(6) 2016 and neuromuscular disorder nos since (b)(6) 2016.Concomitant products included hydroxychloroquine phosphate (plaquenil) and ibuprofen.In 2013, the patient experienced vaginal haemorrhage ("abnormal bleeding vaginal"), menorrhagia ("abnormal bleeding menorrhagia") and alopecia ("hair loss").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain ("pain") and fatigue ("fatigue").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required) and abdominal pain ("abdominal pain").The patient was treated with surgery ((b)(6) 2016 and (b)(6) 2017, laparoscopy bilateral salpingectomy and surgical removal of coil).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, uterine perforation, pelvic pain, vaginal haemorrhage and menorrhagia outcome was unknown, the abdominal pain had resolved and the fatigue and alopecia was resolving.The reporter considered abdominal pain, alopecia, device breakage, fatigue, menorrhagia, pelvic pain, uterine perforation and vaginal haemorrhage to be related to essure.The reporter commented: patient had a bilateral salpingectomy on (b)(6) 2016 and doctor was really certain of success.But after pathology came inconclusive, she had a series of x rays on (b)(6) 2016, one device was stuck somewhere in abdominal cavity and the other fractured leaving a small piece by uterus.1.5 coils of the device were intrauterine.The contralateral tubal opening was visualized and an essure device placed into that tube up to the, black ring and the device deployed according to the manufacturer's protocol.2.5 coils were visible.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: unilateral occlusion, malposition of essure device patient's pathology came inconclusive, she had a series of x rays on (b)(6) 2016, one device was stuck somewhere in abdominal cavity and the other fractured leaving a small piece by uterus.In 2016, xr abdomen 1 view kub supine was done, indication: 33-year-old female with suspected migration of essure clips.Impression:1.Two essure clips are present within the pelvis.2.Non obstructive bowel gas pattern.In (b)(6) 2016, xr pelvis 1 or 2 vw was done , indication: encounter for sterilization, findings/impression- bilateral essure devices are noted.Mild degenerative changes of the pubic symphysis.Mild degenerative changes at both hip joints.Mild stool burden in the descending colon and rectosigmoid colon.In (b)(6) 2016, xr abdomen series was done.Indication: encounter for sterilization, findings/impression: no pathologic bowel dilatation.Mild stool burden in the descending colon and rectosigmoid colon.No significant gastric distention.Bilateral essure devices projecting over the pelvis.Mild degenerative changes of the symphysis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records- pelvic pain, device breakage, abdominal pain, uterine perforation.Most recent follow-up information incorporated above includes: on 7-sep-2018: plaintiff fact sheet and medical records received - patient¿s age and date of birth added, indication of use added, events vaginal haemorrhage, menorrhagia, fatigue, hair loss, partial expulsion of device, abdominal pain were added.Event perforation updated to uterine perforation.Lab data added.Concomitant diseases were added, concomitant drugs 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing of the implant/ the other fractured leaving a small piece by my uterus') and uterine perforation ('perforation (uterus)/ malposition of essure device location of device: uterine wall/migration of implant/ one device is stuck somewhere in my abdominal cavity/ missing essure device/ one of device placed and floating in body/ one side perforated') in a 31-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included hypermobility syndrome since (b)(6) 2016, breast abscess since (b)(6) 2016, ovarian torsion since (b)(6) 2016, undifferentiated connective tissue disease since (b)(6) 2016, neuromuscular disorder nos since (b)(6) 2016 and dermoid cyst of ovary since (b)(6) 2016.Concomitant products included hydroxychloroquine and ibuprofen.In 2013, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding vaginal"), menorrhagia ("abnormal bleeding menorrhagia") and alopecia ("hair loss").On b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain ("pain/ stabbing pain") and fatigue ("fatigue").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), vomiting ("vomiting"), diarrhoea ("diarrhea"), myalgia ("muscle aches"), pyrexia ("fevers"), rash ("rashes"), headache ("headaches"), mouth ulceration ("mouth ulcers"), lymphadenopathy ("chronic enlarged lymph nodes") and peripheral swelling ("arm swelling").The patient was treated with surgery ((b)(6)2016 and (b)(6)2017, laparoscopy bilateral salpingectomy and surgical removal of coil).Essure was removed on (b)(6)2017.At the time of the report, the device breakage, uterine perforation, vaginal haemorrhage, menorrhagia, vomiting, diarrhoea, myalgia, pyrexia, rash, headache, mouth ulceration and lymphadenopathy outcome was unknown, the pelvic pain and abdominal pain had resolved and the fatigue, alopecia and peripheral swelling was resolving.The reporter considered abdominal pain, alopecia, device breakage, diarrhoea, fatigue, headache, lymphadenopathy, menorrhagia, mouth ulceration, myalgia, pelvic pain, peripheral swelling, pyrexia, rash, uterine perforation, vaginal haemorrhage and vomiting to be related to essure.The reporter commented: patient had a bilateral salpingectomy on (b)(6)2016 and doctor was really certain of success.But after pathology came inconclusive, she had a series of x rays on (b)(6)2016, one device was stuck somewhere in abdominal cavity and the other fractured leaving a small piece by uterus.1.5 coils of the device were intrauterine.The contralateral tubal opening was visualized and an essure device placed into that tube up to the, black ring and the device deployed according to the manufacturer's protocol.2.5 coils were visible.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2013: results: unilateral occlusion, malposition of essure device.Diagnostic results: patient's pathology came inconclusive, she had a series of x rays on (b)(6)2016, one device was stuck somewhere in abdominal cavity and the other fractured leaving a small piece by uterus.*in (b)(6)2016, xr abdomen 1 view kub supine was done, indication: 33-year-old female with suspected migration of essure clips.Impression:1.Two essure clips are present within the pelvis.2.Non obstructive bowel gas pattern.*in (b)(6)2016, xr pelvis 1 or 2 vw was done , indication: encounter for sterilization, findings/impression- bilateral essure devices are noted.Mild degenerative changes of the pubic symphysis.Mild degenerative changes at both hip joints.Mild stool burden in the descending colon and rectosigmoid colon.*in (b)(6)2016, xr abdomen series was done.Indication: encounter for sterilization, findings/impression: no pathologic bowel dilatation.Mild stool burden in the descending colon and rectosigmoid colon.No significant gastric distention.Bilateral essure devices projecting over the pelvis.Mild degenerative changes of the symphysis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records- pelvic pain, device breakage, abdominal pain, uterine perforation.Most recent follow-up information incorporated above includes: on 23-jan-2020: social media received : reporter added.Events added - vomiting, diarrhea, muscle aches, fevers, rashes, headaches, chronic enlarged lymph nodes, arm swelling, mouth ulcers.Outcome of the events updated.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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: 7056476
• MDR Text Key: 92908841
• Report Number: 2951250-2017-08237
• 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
• Report Date: 02/11/2020

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 Model Number: ESS305
• 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: 09/07/2018; 09/07/2018
• Supplement Dates FDA Received: 09/20/2018; 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYDROXYCHLOROQUINE; IBUPROFEN; IBUPROFEN; PLAQUENIL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR