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

Model Number ESS305

Device Problems Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Genital Bleeding (4507); 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 device breakage ('device breakage fracture implant') in a female patient who had essure (batch no.C06513) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), psychological trauma ("psychological injuries") and device dislocation ("device migration").The patient was treated with surgery (surgical removal of coil).Essure was removed.At the time of the report, the device breakage, psychological trauma and device dislocation outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device dislocation, genital haemorrhage, pelvic pain and psychological trauma to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received: new events replaced by injury.New event added, pelvic pain, bleeding, breakage, psyche injury, device migration, and out come of events added.Case become incident.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage fracture implant') in a female patient who had essure (batch no.C06513) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage ("abnormal bleeding"), psychological trauma ("psychological injuries") and device dislocation ("device migration").The patient was treated with surgery (surgical removal of coil).Essure was removed.At the time of the report, the device breakage, psychological trauma and device dislocation outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device dislocation, genital haemorrhage, pelvic pain and psychological trauma to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage fracture implant'), device expulsion ('however, coil of the spring in films appeared to be partially extruded lying in the endometrial cavity') and genital haemorrhage ('abnormal bleeding') in a female patient who had essure (batch no.C06513) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included heavy menstrual bleeding and menometrorrhagia.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage (seriousness criteria medically significant and intervention required) and psychological trauma ("psychological injuries").The patient was treated with surgery (hysteroscopy, dilatation and curettage and removal of foreign body, hysteroscopy, dilatation and curettage, novasure ablation and removal of foreign body and novasure ablation).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device expulsion and psychological trauma outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device expulsion, genital haemorrhage, pelvic pain and psychological trauma to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: hysterosalpingogram confirming proper essure coil obstruction of the fallopian tubes.; on (b)(6) 2015: left tubal micro insert extravasation into the uterine cavity.Essure devices noted bilaterally.There is filling of the endometrial canal.There is venous backflow.No definite flow noted down the fallopian tubes or into the peritoneal cavity.Fallopian tubes seem to be obstructed bilaterally.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 17-may-2021: mr received.Reporter information, patient dob, medical history, lab data, event: device dislocation replaced with essure lying in the endometrial cavity.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage fracture implant'), device expulsion ('however, coil of the spring in films appeared to be partially extruded lying in the endometrial cavity') and genital haemorrhage ('abnormal bleeding') in a female patient who had essure (batch no.C06513) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included heavy menstrual bleeding and menometrorrhagia.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), genital haemorrhage (seriousness criteria medically significant and intervention required) and psychological trauma ("psychological injuries").The patient was treated with surgery (hysteroscopy, dilatation and curettage and removal of foreign body, hysteroscopy, dilatation and curettage, novasure ablation and removal of foreign body and novasure ablation).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device expulsion and psychological trauma outcome was unknown and the pelvic pain and genital haemorrhage had resolved.The reporter considered device breakage, device expulsion, genital haemorrhage, pelvic pain and psychological trauma to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2015: hysterosalpingogram confirming proper essure coil obstruction of the fallopian tubes; on (b)(6) 2015: left tubal micro insert extravasation into the uterine cavity.Essure devices noted bilaterally.There is filling of the endometrial canal.There is venous backflow.No definite flow noted down the fallopian tubes or into the peritoneal cavity.Fallopian tubes seem to be obstructed bilaterally.Batch no c06513; production date 2013-12-21; expiration date 2016-12-31.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on 26-may-2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: 10131978
• MDR Text Key: 194459467
• Report Number: 2951250-2020-08478
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: ESS305
• Device Lot Number: C06513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention