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

Model Number ESS305

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Expulsion (2933); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problems Uterine Perforation (2121); Genital Bleeding (4507); Pregnancy with a Contraceptive Device (4517)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pregnancy with contraceptive device ('preg'), abortion spontaneous ('miscarried at 6 wks') and abnormal uterine bleeding ('abnormal uterine bleeding') in an adult female patient who had essure inserted for female sterilisation.Other product or product use issues identified: device ineffective "device ineffective" and device physical property issue "coil was bent".The patient's medical history included procedural pain, muscle cramps, gastric bypass, cystoscopy and hemostasis.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient was found to have a pregnancy with contraceptive device (seriousness criterion medically significant) and experienced abortion spontaneous (seriousness criterion medically significant) and abnormal uterine bleeding (seriousness criteria medically significant and intervention required).The patient was treated with surgery (hysterectomy total abdominal laparoscopic.Salpingectomy laparoscopic).Essure was removed on (b)(6) 2021.At the time of the report, the pregnancy with contraceptive device had resolved and the abortion spontaneous outcome was unknown.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abnormal uterine bleeding, abortion spontaneous and pregnancy with contraceptive device to be related to essure.The reporter commented: complete coils protruding into uterine cavity: right-1 left-2.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hemostasis.Quality-safety evaluation of ptc: in this case no product was returned.We conduct an investigation of any returned device.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.A ptc investigation cannot be initiated as no batch number, or sample, provided thus resulting in an unconfirmed quality defect most recent follow-up information incorporated above includes: on 15-jul-2021: mr received : reporter information , other relevant history, explant date, event added - 'abnormal uterine bleeding', 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 uterine perforation ('left micro-insert coiled consistent with perforation'), abnormal uterine bleeding ('abnormal uterine bleeding'), pregnancy with contraceptive device ('pregnancy ') and abortion spontaneous ('miscarried at 6 wks') in an adult female patient who had essure inserted for female sterilisation.Other product or product use issues identified: device ineffective "device ineffective/one of her fallopian tubes was not properly occluded" and device physical property issue "coil was bent".The patient's medical history included procedural pain, muscle cramps, gastric bypass, cystoscopy, hemostasis, obesity, iron deficiency anemia, thrombosis venous deep, uterine fibroids, dysmenorrhea and menorrhagia.Dye confirmed.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), abnormal uterine bleeding (seriousness criteria medically significant and intervention required) and abortion spontaneous (seriousness criterion medically significant) and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).The patient was treated with surgery (laparoscopic total abdominal hysterectomy with salpingectomy and laparoscopic total abdominal hysterectomywith salpingectomy, blood transfusion on (b)(6) 2019).Essure was removed on (b)(6) 2021.At the time of the report, the uterine perforation, abnormal uterine bleeding and abortion spontaneous outcome was unknown and the pregnancy with contraceptive device had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abnormal uterine bleeding, abortion spontaneous, pregnancy with contraceptive device and uterine perforation to be related to essure.The reporter commented: complete coils protruding into uterine cavity: right-1 left-2.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results: dye confirmed; on (b)(6) 2014: -one of her fallopian tubes was not properly occluded -left micro-insert coiled consistent with perforation.Uterine cavity within normal limits otherwise, right micro-insert correctly positioned.Pregnancy test urine - on an unknown date: negative.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 10-nov-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('left micro-insert coiled consistent with perforation'), abnormal uterine bleeding ('abnormal uterine bleeding'), pregnancy with contraceptive device ('preg') and abortion spontaneous ('miscarried at 6 wks') in an adult female patient who had essure inserted for female sterilisation.Other product or product use issues identified: device ineffective "device ineffective/one of her fallopian tubes was not properly occluded" and device physical property issue "coil was bent".The patient's medical history included procedural pain, muscle cramps, gastric bypass, cystoscopy, hemostasis, obesity, iron deficiency anemia, thrombosis venous deep, uterine fibroids, dysmenorrhea and menorrhagia.Dye confirmed.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), abnormal uterine bleeding (seriousness criteria medically significant and intervention required) and abortion spontaneous (seriousness criterion medically significant) and was found to have a pregnancy with contraceptive device (seriousness criterion medically significant).The patient was treated with surgery (laparoscopic total abdominal hysterectomy with salpingectomy and laparoscopic total abdominal hysterectomy with salpingectomy, blood transfusion on (b)(6) 2019).Essure was removed on (b)(6) 2021.At the time of the report, the uterine perforation, abnormal uterine bleeding and abortion spontaneous outcome was unknown and the pregnancy with contraceptive device had resolved.Pregnancy related information: retrospective report.Last menstrual period and estimated date of delivery were not provided.Potential fetal exposure to essure occurred during the first trimester.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abnormal uterine bleeding, abortion spontaneous, pregnancy with contraceptive device and uterine perforation to be related to essure.The reporter commented: complete coils protruding into uterine cavity: right-1 left-2.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on an unknown date: results: dye confirmed; on (b)(6) 2014: -one of her fallopian tubes was not properly occluded.Left micro-insert coiled consistent with perforation.Uterine cavity within normal limits otherwise, right micro-insert correctly positioned.Pregnancy test urine - on an unknown date: negative.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: hemostasis.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: uterine perforation.Quality-safety evaluation of ptc: in this case no product was returned.We conduct an investigation of any returned device.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.A ptc investigation cannot be initiated as no batch number, or sample, provided thus resulting in an unconfirmed quality defect.Most recent follow-up information incorporated above includes: on 2-nov-2021: mr received.Medical history, lab data added.Event: left micro-insert coiled consistent with perforation added.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
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 12217673
• MDR Text Key: 263958875
• Report Number: 2951250-2021-02937
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Female