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

Model Number ESS305

Device Problems Separation Failure (2547); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B82477) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test" and device deployment issue "coil did not separate from the insertion device,with the second attempt the coil was deployed successfully into the left fallopian tube".On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding (general)"), back pain ("back pain") and migraine ("migraine/headache").The patient was treated with surgery (bilateral salpingectomy).Essure was removed in (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, back pain and migraine outcome was unknown.The reporter considered back pain, genital haemorrhage, migraine and pelvic pain to be related to essure.The reporter commented: per medical record: essure insertion date: (b)(6) 2014 (discrepancy noted).Most recent follow-up information incorporated above includes: on 30-mar-2020: plaintiff fact sheet received.This case is medically confirmed.The case was upgraded from non-serious incident to serious incident.Previously reported unspecified event ¿injury¿ was updated to more specified events¿ abnormal bleeding (general); migraines/headaches; pelvic pain, medical device monitoring error and back pain.Patient demographics, essure insertion/removal date, essure lot number and reporter 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 pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B82477) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test" and device deployment issue "coil did not separate from the insertion device,with the second attempt the coil was deployed successfully into the left fallopian tube." on (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal bleeding (general)"), back pain ("back pain") and migraine ("migraine/headache").The patient was treated with surgery (bilateral salpingectomy).Essure was removed in (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, back pain and migraine outcome was unknown.The reporter considered back pain, genital haemorrhage, migraine and pelvic pain to be related to essure.The reporter commented: per medical record: essure insertion date: (b)(6) 2014.(discrepancy noted).Batch no b82477 production date 2013-10-16 expiration date 2016-10-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-may-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 pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B82477) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test" and device deployment issue "coil did not separate from the insertion device,with the second attempt the coil was deployed successfully into the left fallopian tube".Concomitant products included ethinylestradiol;norgestimate (tri-sprintec).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced migraine ("migraine/headache").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), muscle spasms ("cramping in my legs/leg pain") and hypoaesthesia ("numbness in my legs").In (b)(6) 2015, the patient experienced urinary tract infection ("uti").On an unknown date, the patient experienced genital haemorrhage ("abnormal bleeding (general)").The patient was treated with antibiotics, paracetamol (tylenol) and surgery (bilateral salpingectomy).Essure was removed in (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, back pain, menorrhagia, vaginal haemorrhage, muscle spasms and hypoaesthesia was resolving and the migraine and urinary tract infection outcome was unknown.The reporter considered back pain, genital haemorrhage, hypoaesthesia, menorrhagia, migraine, muscle spasms, pelvic pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: per medical record: essure insertion date: (b)(6) 2014 (discrepancy noted).Batch no b82477 production date 2013-10-16 expiration date 2016-10-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-jan-2021: pif received : new events abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), uti , numbness in my legs, cramping in my legs were added.Outcome of back pain, pelvic pain, leg pain, genital haemorrhage updated to recovering / resolving.New reporters, height, concomitant and treatment drugs were added.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 embedded device ('the lumen is visible and embedded with a gray metallic coiled wire'), device dislocation ('displacement of intrauterine contraceptive device') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B82477) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test" and device deployment issue "coil did not separate from the insertion device,with the second attempt the coil was deployed successfully into the left fallopian tube".Concomitant products included ethinylestradiol;norgestimate (tri-sprintec).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced migraine ("migraine/headache").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), muscle spasms ("cramping in my legs/leg pain") and hypoaesthesia ("numbness in my legs").In (b)(6) 2015, the patient experienced urinary tract infection ("uti").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) and genital haemorrhage ("abnormal bleeding (general)").The patient was treated with antibiotics, paracetamol (tylenol) and surgery (bilateral salpingectomy, diagnostic hysteroscopy with laparoscopic bilateral removal of essure device and salpingectomy and hysterectomy removal of essure implant/laparoscopic bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, device dislocation, migraine and urinary tract infection outcome was unknown and the pelvic pain, genital haemorrhage, back pain, menorrhagia, vaginal haemorrhage, muscle spasms and hypoaesthesia was resolving.The reporter considered back pain, device dislocation, embedded device, genital haemorrhage, hypoaesthesia, menorrhagia, migraine, muscle spasms, pelvic pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: per medical record: essure insertion date: (b)(6) 2014 (discrepancy noted).Batch no b82477 production date 2013-10-16 expiration date 2016-10-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2021: pfs and mr received: events the lumen is visible and embedded with a grey metallic coiled wire and displacement of intrauterine contraceptive device added and made medically significant and intervention required due to surgery.Reporter and essure removal date updated.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 embedded device ('the lumen is visible and embedded with a gray metallic coiled wire'), device dislocation ('displacement of intrauterine contraceptive device') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B82477) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test" and device deployment issue "coil did not separate from the insertion device,with the second attempt the coil was deployed successfully into the left fallopian tube".Concomitant products included ethinylestradiol;norgestimate (tri-sprintec).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced migraine ("migraine/headache").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), muscle spasms ("cramping in my legs/leg pain") and hypoaesthesia ("numbness in my legs").In (b)(6) 2015, the patient experienced urinary tract infection ("uti").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) and genital haemorrhage ("abnormal bleeding (general)").The patient was treated with antibiotics, paracetamol (tylenol) and surgery (bilateral salpingectomy, diagnostic hysteroscopy with laparoscopic bilateral removal of essure device and salpingectomy and hysterectomy removal of essure implant/laparoscopic bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, device dislocation, migraine and urinary tract infection outcome was unknown and the pelvic pain, genital haemorrhage, back pain, menorrhagia, vaginal haemorrhage, muscle spasms and hypoaesthesia was resolving.The reporter considered back pain, device dislocation, embedded device, genital haemorrhage, hypoaesthesia, menorrhagia, migraine, muscle spasms, pelvic pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: per medical record: essure insertion date: (b)(6) 2014.(discrepancy noted).Batch no b82477.Production date 2013-10-16.Expiration date 2016-10-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('the lumen is visible and embedded with a gray metallic coiled wire'), device dislocation ('displacement of intrauterine contraceptive device') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.B82477) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "did not undergo confirmation test" and device deployment issue "coil did not separate from the insertion device,with the second attempt the coil was deployed successfully into the left fallopian tube".Concomitant products included ethinylestradiol;norgestimate (tri-sprintec).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced migraine ("migraine/headache").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), heavy menstrual bleeding ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), muscle spasms ("cramping in my legs/leg pain") and hypoaesthesia ("numbness in my legs").In (b)(6) 2015, the patient experienced urinary tract infection ("uti").On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) and genital haemorrhage ("abnormal bleeding (general)").The patient was treated with antibiotics, paracetamol (tylenol) and surgery (bilateral salpingectomy, diagnostic hysteroscopy with laparoscopic bilateral removal of essure device and salpingectomy and hysterectomy removal of essure implant/laparoscopic bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the embedded device, device dislocation, migraine and urinary tract infection outcome was unknown and the pelvic pain, genital haemorrhage, back pain, heavy menstrual bleeding, vaginal haemorrhage, muscle spasms and hypoaesthesia was resolving.The reporter considered back pain, device dislocation, embedded device, genital haemorrhage, heavy menstrual bleeding, hypoaesthesia, migraine, muscle spasms, pelvic pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: per medical record: essure insertion date: (b)(6) 2014.(discrepancy noted).Batch no b82477, production date 2013-10-16, and expiration date 2016-10-31.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-apr-2021: plaintiff fact sheet received.Essure insertion date updated.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: 10004591
• MDR Text Key: 189739998
• Report Number: 2951250-2020-05802
• 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: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: ESS305
• Device Lot Number: B82477
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRI-SPRINTEC; TRI-SPRINTEC; TRI-SPRINTEC; TRI-SPRINTEC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR