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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Perforation (2001)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of blood loss anaemia ('anemia') and device dislocation ('no corresponding echogenic focus in the left adnexa') in an adult 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 fibroids, menorrhagia, adenomyosis and chronic anemia.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced blood loss anaemia (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), blood disorder ("blood/ heart disorder"), cardiac disorder ("blood/ heart disorder"), urinary tract disorder ("bladder/urinary problems:urinary problems"), cystitis ("bladder/urinary problems:bladder infection"), urinary tract infection ("bladder/ urinary problems: urinary tract infection"), vaginal infection ("bladder/ urinary problems: vaginal infection"), vaginal discharge ("bladder/ urinary problems:vaginal discharge") and fatigue ("fatigue") and was found to have weight increased ("weight gain").The patient was treated with surgery (laparoscopic supracervical hysterectomy.).Essure was removed on (b)(6) 2011.At the time of the report, the blood loss anaemia, device dislocation, dysmenorrhoea, dyspareunia, blood disorder, cardiac disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue and weight increased outcome was unknown.The reporter considered blood disorder, blood loss anaemia, cardiac disorder, cystitis, device dislocation, dysmenorrhoea, dyspareunia, fatigue, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal infection and weight increased to be related to essure.The reporter commented: she received treatment for dysmenorrhea, dyspareunia, anemia, blood disorder, heart disorder, urinary problems, bladder infection, urinary tract infection, vaginal infection, vaginal discharge, fatigue, weight gain echogenic focus in the right adnexa measuring 0.8 cm in greatest dimension.This is presumably an essure device.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2008: essure confirmation test unknown: not provided.Ultrasound pelvis - on (b)(6) 2020: no corresponding echogenic focus in the left adnexa.Sonographically normal ovaries.Concerning the injuries reported in this case, the following ones were reported in patient¿s medical records: device dislocation.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 27-aug-2021: mr received: reporter information, lab data, event- "device dislocation", added.Rcc 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of blood loss anaemia ('anemia') and device dislocation ('no corresponding echogenic focus in the left adnexa') in an adult 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 fibroids, menorrhagia, adenomyosis and chronic anemia.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced blood loss anaemia (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmennorhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), blood disorder ("blood/heart disorder"), cardiac disorder ("blood/heart disorder"), urinary tract disorder ("bladder/urinary problems:urinary problems"), cystitis ("bladder/urinary problems:bladder infection"), urinary tract infection ("bladder/urinary problems:urinary tract infection"), vaginal infection ("bladder/urinary problems:vaginal infection"), vaginal discharge ("bladder/urinary problems:vaginal discharge") and fatigue ("fatigue") and was found to have weight increased ("weight gain").The patient was treated with surgery (laparoscopic supracervical hysterectomy.).Essure was removed on (b)(6) 2011.At the time of the report, the blood loss anaemia, device dislocation, dysmenorrhoea, dyspareunia, blood disorder, cardiac disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue and weight increased outcome was unknown.The reporter considered blood disorder, blood loss anaemia, cardiac disorder, cystitis, device dislocation, dysmenorrhoea, dyspareunia, fatigue, urinary tract disorder, urinary tract infection, vaginal discharge, vaginal infection and weight increased to be related to essure.The reporter commented: she received treatment for dysmenorrhea, dyspareunia, anemia, blood disorder, heart disorder, urinary problems, bladder infection, urinary tract infection, vaginal infection, vaginal discharge, fatigue, weight gain echogenic focus in the right adnexa measuring 0.8 cm in greatest dimension.This is presumably an essure device.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2008: essure confirmation test unknown: not provided.Ultrasound pelvis - on (b)(6) 2020: no corresponding echogenic focus in the left adnexa.Sonographically normal ovaries.Concerning the injuries reported in this case, the following ones were reported in patient¿s medical records: device dislocation.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 3-sep-2021: quality safety evaluation of product technical complaint.Based on the available information, a review of our complaint records and other relevant data was 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: 12409055
• MDR Text Key: 269490118
• Report Number: 2951250-2021-03143
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention