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

Model Number ESS305

Device Problems Material Fragmentation (1261); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('essure removal') in an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removed).Essure was removed on (b)(6) 2019.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.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 (b)(6) 2021: pif received.Event injury nos was updated to medical device removal.Essure insertion and removal dates were added.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('portion of this wire is found free-floating within the endometrial cavity (1.2 cm in length)') 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 medical history included anemia, migraine, menses irregular, adenomyosis, uterine leiomyoma and paratubal cyst.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("menorrhagia") and iron deficiency anaemia ("iron deficiency anemia").The patient was treated with surgery (total laparoscopic hysterectomy, bilateral salpingectomy and cystourethroscopy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, heavy menstrual bleeding and iron deficiency anaemia outcome was unknown.The reporter considered device breakage, heavy menstrual bleeding and iron deficiency anaemia to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: device breakage, menorrhagia, iron deficiency anemia.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 5-may-2021: medical record received: event medical device removal replaced with portion of this wire is found free-floating within the endometrial cavity.Reporter information, medical history added.Events menorrhagia and iron deficiency anemia added.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('portion of this wire is found free-floating within the endometrial cavity (1.2 cm in length)') 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 medical history included anemia, migraine, menses irregular, adenomyosis, uterine leiomyoma and paratubal cyst.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), heavy menstrual bleeding ("menorrhagia") and iron deficiency anaemia ("iron deficiency anemia").The patient was treated with surgery (total laparoscopic hysterectomy, bilateral salpingectomy and cystourethroscopy).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, heavy menstrual bleeding and iron deficiency anaemia outcome was unknown.The reporter considered device breakage, heavy menstrual bleeding and iron deficiency anaemia to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: device breakage, menorrhagia, iron deficiency anemia.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 4-jun-2021: quality safety evaluation of ptc.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: 11803810
• MDR Text Key: 263127551
• Report Number: 2951250-2021-01851
• 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,Followup
• Report Date: 06/04/2021

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
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 05/05/2021; 06/04/2021
• Supplement Dates FDA Received: 05/17/2021; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention