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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2015

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('removal') in a (b)(6) female patient who had essure inserted for female sterilization.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2015, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (removal).Essure was removed on (b)(6) 2015.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: unable to confirm 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('removal') in a 41-year-old female patient who had essure inserted for female sterilization.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2015, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (removal).Essure was removed on (b)(6) 2015.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: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-jul-2020: 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('embedded at the fundus are coiled metallic fragments') and embedded device ('embedded at the fundus are coiled metallic fragments') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included pregnancy test urine negative, menorrhagia and paratubal cyst.Concomitant products included diazepam (valium) and ketorolac tromethamine (toradol).On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device expulsion ("embedded at the fundus are coiled metallic fragments") and embedded device (seriousness criteria medically significant and intervention required).The patient was treated with surgery (complete laparoscopic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device expulsion and embedded device outcome was unknown.The reporter considered device breakage, device expulsion and embedded device to be related to essure.The reporter commented: trailing into the uterine cavity was 4.Insertion date updated (as written per mr)- (b)(6) 2013.Removal date updated (as written per mr) - (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: bilaterally essure devices in good position, no spillage.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records- embedded device, device breakage, device expulsion.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 19-may-2021: medical record received : reporter information, medical history, event medical device removal replace with embedded at the fundus are coiled metallic fragments,device breakage and device expulsion rcc lab data, concomitant medication and insertion and removal date were 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 device breakage ('embedded at the fundus are coiled metallic fragments') and embedded device ('embedded at the fundus are coiled metallic fragments') in a 41-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included pregnancy test urine negative, menorrhagia and paratubal cyst.Concomitant products included diazepam (valium) and ketorolac tromethamine (toradol).On (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device expulsion ("embedded at the fundus are coiled metallic fragments") and embedded device (seriousness criteria medically significant and intervention required).The patient was treated with surgery (complete laparoscopic hysterectomy, bilateral salpingectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device expulsion and embedded device outcome was unknown.The reporter considered device breakage, device expulsion and embedded device to be related to essure.The reporter commented: trailing into the uterine cavity was 4 insertion date updated (as written per mr)- (b)(6) 2013 to (b)(6) 2013 removal date updated (as written per mr) - (b)(6) 2015 to (b)(6) 2015 diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: bilaterally essure devices in good position, no spillage.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records- embedded device, device breakage, device expulsion.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 31-may-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: 10218658
• MDR Text Key: 197177952
• Report Number: 2951250-2020-10206
• 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,Followup
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TORADOL; TORADOL; VALIUM; VALIUM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 41 YR