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

Model Number ESS305

Device Problems Break (1069); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994); Perforation (2001); Uterine Perforation (2121); Cramp(s) (2193); Anxiety (2328); Depression (2361); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ("migration/perforation"), genital haemorrhage ("bleeding"), autoimmune disorder ("autoimmune-like symptoms") and rheumatoid arthritis ("rheumatoid arthritis") in a female patient who had essure (batch no.50500521) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cesarean section, allergic reaction to analgesics and drug hypersensitivity.Previously administered products included for an unreported indication: nuvaring.Concomitant products included ethinylestradiol; etonogestrel (nuvaring) for contraception.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), pelvic pain ("pain"), fatigue ("fatigue"), visual impairment ("vision problems"), premature menopause ("early menopause"), abdominal pain lower ("cramping"), anxiety ("anxiety"), depression ("depression") and libido decreased ("low sex drive").The patient was treated with surgery (removal surgery scheduled for (b)(6) 2019).Essure was removed on (b)(6) 2019.At the time of the report, the perforation, genital haemorrhage, autoimmune disorder, rheumatoid arthritis, pelvic pain, fatigue, visual impairment, premature menopause, abdominal pain lower, anxiety, depression and libido decreased outcome was unknown.The reporter considered abdominal pain lower, anxiety, autoimmune disorder, depression, fatigue, genital haemorrhage, libido decreased, pelvic pain, perforation, premature menopause, rheumatoid arthritis and visual impairment to be related to essure.The reporter commented: removal surgery scheduled for (b)(6) 2019.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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration/perforation"), genital haemorrhage ("bleeding"), autoimmune disorder ("autoimmune-like symptoms") and rheumatoid arthritis ("rheumatoid arthritis") in a female patient who had essure (batch no.50500521) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cesarean section, allergic reaction to analgesics and drug hypersensitivity.Previously administered products included for an unreported indication: nuvaring.Concomitant products included ethinylestradiol;etonogestrel (nuvaring) for contraception.On (b)(6)2010, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), pelvic pain ("pain"), fatigue ("fatigue"), visual impairment ("vision problems"), premature menopause ("early menopause"), abdominal pain lower ("cramping"), anxiety ("anxiety"), depression ("depression") and libido decreased ("low sex drive").The patient was treated with surgery (removal surgery scheduled for (b)(6)2019).Essure was removed on (b)(6)2019.At the time of the report, the uterine perforation, genital haemorrhage, autoimmune disorder, rheumatoid arthritis, pelvic pain, fatigue, visual impairment, premature menopause, abdominal pain lower, anxiety, depression and libido decreased outcome was unknown.The reporter considered abdominal pain lower, anxiety, autoimmune disorder, depression, fatigue, genital haemorrhage, libido decreased, pelvic pain, premature menopause, rheumatoid arthritis, uterine perforation and visual impairment to be related to essure.The reporter commented: removal surgery scheduled for (b)(6)2019.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-apr-2019: quality-safety evaluation of ptc.(product technical complaint).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 non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('migration/perforation'), autoimmune disorder ('autoimmune-like symptoms') and rheumatoid arthritis ('rheumatoid arthritis') in an adult female patient who had essure (batch no.50500521) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cesarean section, allergic reaction to analgesics and drug hypersensitivity.Previously administered products included for an unreported indication: nuvaring.Concomitant products included ethinylestradiol;etonogestrel (nuvaring) for contraception.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding"), autoimmune disorder (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), pelvic pain ("pain"), fatigue ("fatigue"), visual impairment ("vision problems"), premature menopause ("early menopause"), abdominal pain lower ("cramping"), anxiety ("anxiety"), depression ("depression"), libido decreased ("low sex drive") and menstrual disorder ("unusual periods").The patient was treated with surgery (removal surgery scheduled for (b)(6) 2019).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, genital haemorrhage, autoimmune disorder, rheumatoid arthritis, pelvic pain, fatigue, visual impairment, premature menopause, abdominal pain lower, anxiety, depression, libido decreased and menstrual disorder outcome was unknown.The reporter considered abdominal pain lower, anxiety, autoimmune disorder, depression, fatigue, genital haemorrhage, libido decreased, menstrual disorder, pelvic pain, premature menopause, rheumatoid arthritis, uterine perforation and visual impairment to be related to essure.The reporter commented: removal surgery scheduled for (b)(6)2019.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-aug-2020: quality-safety evaluation of product technical complaint.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 uterine perforation ('migration/perforation'), autoimmune disorder ('autoimmune-like symptoms') and rheumatoid arthritis ('rheumatoid arthritis') in an adult female patient who had essure (batch no.50500521) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cesarean section, allergic reaction to analgesics and drug hypersensitivity.Previously administered products included for an unreported indication: nuvaring.Concomitant products included ethinylestradiol;etonogestrel (nuvaring) for contraception.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding"), autoimmune disorder (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), pelvic pain ("pain"), fatigue ("fatigue"), visual impairment ("vision problems"), premature menopause ("early menopause"), abdominal pain lower ("cramping"), anxiety ("anxiety"), depression ("depression"), libido decreased ("low sex drive") and menstrual disorder ("unusual periods").The patient was treated with surgery (removal surgery scheduled for 11jan2019).Essure was removed on (b)(6) 2019.At the time of the report, the uterine perforation, genital haemorrhage, autoimmune disorder, rheumatoid arthritis, pelvic pain, fatigue, visual impairment, premature menopause, abdominal pain lower, anxiety, depression, libido decreased and menstrual disorder outcome was unknown.The reporter considered abdominal pain lower, anxiety, autoimmune disorder, depression, fatigue, genital haemorrhage, libido decreased, menstrual disorder, pelvic pain, premature menopause, rheumatoid arthritis, uterine perforation and visual impairment to be related to essure.The reporter commented: removal surgery scheduled for 11-jan-2019.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-aug-2020: pfs received.Event "unusual periods" added.Genital hemorrhage downgraded.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 ('fragments of metallic wire, consistent with essure coils'), uterine perforation ('migration/perforation/essure seen in uterus near fundus (possibly near vs through serosa) toward right adnexa'), autoimmune disorder ('autoimmune-like symptoms') and rheumatoid arthritis ('rheumatoid arthritis') in an adult female patient who had essure (batch no.50500521) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included cesarean section (cesarean section 2), allergic reaction to analgesics and drug hypersensitivity.Previously administered products included for an unreported indication: nuvaring.Concomitant products included ethinylestradiol; etonogestrel (nuvaring) for contraception.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding"), autoimmune disorder (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), pelvic pain ("pain"), fatigue ("fatigue"), visual impairment ("vision problems"), premature menopause ("early menopause"), abdominal pain lower ("cramping"), anxiety ("anxiety"), depression ("depression"), libido decreased ("low sex drive") and menstrual disorder ("unusual periods").The patient was treated with surgery (laparoscopic bilateral salpingectomy,laparoscopic removal of left, hysteroscopic removal of right es and laparoscopic removal of left essure, hysteroscopic removal of right essure).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, uterine perforation, genital haemorrhage, autoimmune disorder, rheumatoid arthritis, pelvic pain, fatigue, visual impairment, premature menopause, abdominal pain lower, anxiety, depression, libido decreased and menstrual disorder outcome was unknown.The reporter considered abdominal pain lower, anxiety, autoimmune disorder, depression, device breakage, fatigue, genital haemorrhage, libido decreased, menstrual disorder, pelvic pain, premature menopause, rheumatoid arthritis, uterine perforation and visual impairment to be related to essure.The reporter commented: the device was deployed with only one trailing coil on this side.Within the proximal portion there is coiled wire within the lumen.Within the container there is additional pieces of gray-tan coiled metal wires consistent with essure wires that measure from 1.5 to 7.0 cm in length.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2019: fallopian tubes and essure coils, bilateral, salpingectomy: two segments of completely transected unremarkable fallopian tubes.Fragments of metallic wire, consistent with essure coils specimens: bilateral fallopian tubes with essure coils.'concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: device breakage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-oct-2020: mr received.Reporter's information added.New event added: device breakage.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 ('fragments of metallic wire, consistent with essure coils'), uterine perforation ('migration/perforation/essure seen in uterus near fundus (possibly near vs through serosa) toward right adnexa'), autoimmune disorder ('autoimmune-like symptoms') and rheumatoid arthritis ('rheumatoid arthritis') in an adult female patient who had essure (batch no.50500521) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cesarean section (cesarean section 2), allergic reaction to analgesics and drug hypersensitivity.Previously administered products included for an unreported indication: nuvaring.Concomitant products included ethinylestradiol;etonogestrel (nuvaring) for contraception.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage ("bleeding"), autoimmune disorder (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), pelvic pain ("pain"), fatigue ("fatigue"), visual impairment ("vision problems"), premature menopause ("early menopause"), abdominal pain lower ("cramping"), anxiety ("anxiety"), depression ("depression"), libido decreased ("low sex drive") and menstrual disorder ("unusual periods").The patient was treated with surgery (laparoscopic bilateral salpingectomy,laparoscopic removal of left, hysteroscopic removal of right es and laparoscopic removal of left essure, hysteroscopic removal of right essure).Essure was removed on (b)(6) 2019.At the time of the report, the device breakage, uterine perforation, genital hemorrhage, autoimmune disorder, rheumatoid arthritis, pelvic pain, fatigue, visual impairment, premature menopause, abdominal pain lower, anxiety, depression, libido decreased and menstrual disorder outcome was unknown.The reporter considered abdominal pain lower, anxiety, autoimmune disorder, depression, device breakage, fatigue, genital hemorrhage, libido decreased, menstrual disorder, pelvic pain, premature menopause, rheumatoid arthritis, uterine perforation and visual impairment to be related to essure.The reporter commented: the device was deployed with only one trailing coil on this side.Within the proximal portion there is coiled wire within the lumen.Within the container there is additional pieces of gray-tan coiled metal wires consistent with essure wires that measure from 1.5 to 7.0 cm in length.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2019: fallopian tubes and essure coils, bilateral, salpingectomy: two segments of completely transected unremarkable fallopian tubes.Fragments of metallic wire, consistent with essure coils.Specimens: bilateral fallopian tubes with essure coils.'concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records: device breakage.Lot number: 50500521.Manufacturing date: 2010-01.Expiration date: 2013-01.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 12-oct-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.

• 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: 8385692
• MDR Text Key: 137677970
• Report Number: 2951250-2019-00957
• 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,Followup
• Report Date: 10/12/2020

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 Expiration Date: 01/01/2013
• Device Model Number: ESS305
• Device Lot Number: 50500521
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/04/2019
• Supplement Dates Manufacturer Received: 04/03/2019; 08/03/2020; 08/19/2020; 10/02/2020; 10/12/2020
• Supplement Dates FDA Received: 04/08/2019; 08/13/2020; 08/24/2020; 10/08/2020; 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUVARING; NUVARING; NUVARING; NUVARING; NUVARING; NUVARING; NUVARING
• Patient Outcome(s): Other; Required Intervention