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

Model Number ESS205

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Cramp(s) (2193); Abdominal Cramps (2543)

Event Date 02/01/2006

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/ pain/ pelvic area") and menstrual disorder ("menstruation issues") in an adult female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test".The patient's concurrent conditions included secondary dysmenorrhea, cramp in lower abdomen, iron deficiency anemia and perineal pain.Concomitant products included levonorgestrel (mirena).In (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").On an unknown date, the patient experienced menstrual disorder (seriousness criteria medically significant and intervention required) and infection ("infections").The patient was treated with surgery (underwent laparoscopy essure removal due to complications from the essure device).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menstrual disorder, dyspareunia, infection, vaginal haemorrhage and menorrhagia had not resolved.The reporter considered dyspareunia, infection, menorrhagia, menstrual disorder, pelvic pain and vaginal haemorrhage to be related to essure (ess205).Most recent follow-up information incorporated above includes: on (b)(6) 2018: reporters added and updated patient demographics.Concomitant disease and concomitant drugs were added.Updated suspect drug inaction.Added events abnormal bleeding (vaginal, menorrhagia) and did you undergo an essure confirmation test.On (b)(6) 2016, she explanted 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

Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe pelvic pain/ pain/ pelvic area") and menstrual disorder ("menstruation issues") in an adult female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test".The patient's concurrent conditions included secondary dysmenorrhea, cramp in lower abdomen, iron deficiency anemia and perineal pain.Concomitant products included levonorgestrel (mirena).In (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), anaemia ("anemia."), depression ("depression"), anxiety ("mental anguish") and dysmenorrhoea ("dysmenorrhea(cramping)").On an unknown date, the patient experienced menstrual disorder (seriousness criteria medically significant and intervention required) and infection ("infections").The patient was treated with surgery (underwent laparoscopy essure removal due to complications from the essure device) and surgery (laparoscopic essure removal).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menstrual disorder, dyspareunia, infection, vaginal haemorrhage and menorrhagia had not resolved and the anaemia, depression, anxiety and dysmenorrhoea outcome was unknown.The reporter considered anaemia, anxiety, depression, dysmenorrhoea, dyspareunia, infection, menorrhagia, menstrual disorder, pelvic pain and vaginal haemorrhage to be related to essure (ess205).Most recent follow-up information incorporated above includes: on 30-oct-2018: pfs received- new event depression, mental anguish, dysmenorrhea(cramping), anemia 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain/ pain/ pelvic area') and menstrual disorder ('menstruation issues') in an adult female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did you undergo an essure confirmation test".The patient's concurrent conditions included secondary dysmenorrhea, cramp in lower abdomen, iron deficiency anemia and perineal pain.Concomitant products included levonorgestrel (mirena).On (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2006, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), dyspareunia ("dyspareunia/ dyspareunia (painful sexual intercourse)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), anaemia ("anemia."), depression ("depression"), anxiety ("mental anguish") and dysmenorrhoea ("dysmenorrhea(cramping)").On an unknown date, the patient experienced menstrual disorder (seriousness criteria medically significant and intervention required), infection ("infections") and urinary tract disorder ("bladder/ urinary problem, bladder problem").The patient was treated with surgery (laparoscopic essure removal and underwent laparoscopy essure removal due to complications from the essure device).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the pelvic pain and vaginal haemorrhage had resolved, the menstrual disorder, dyspareunia, infection and menorrhagia had not resolved and the anaemia, depression, anxiety, dysmenorrhoea and urinary tract disorder outcome was unknown.The reporter considered anaemia, anxiety, depression, dysmenorrhoea, dyspareunia, infection, menorrhagia, menstrual disorder, pelvic pain, urinary tract disorder and vaginal haemorrhage to be related to essure (ess205).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: pif received.Added new event urinary tract disorder.Updated outcome for event pelvic pain and abnormal bleeding to recovered.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: 7572583
• MDR Text Key: 110237713
• Report Number: 2951250-2018-02508
• 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: 06/02/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 10/30/2018; 01/09/2020
• Supplement Dates FDA Received: 11/08/2018; 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MIRENA; MIRENA; MIRENA; MIRENA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26 YR