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

Model Number ESS305

Device Problems Break (1069); Unraveled Material (1664); Separation Failure (2547); Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Hemorrhage/Bleeding (1888); Pain (1994); Thyroid Problems (2102); Uterine Perforation (2121); Weight Changes (2607); No Code Available (3191)

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting which took place in september 2015 (case# fda-2014-n-0736-1412, awareness date 04-oct-2015).It refers to a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2013.To begin, there was a malfunction of the product during the implantation where the right coil remained attached to the camera, and unraveled.Not only was it not implanted, but it was terribly painful and resulted in excessive bleeding.During the dye test a month later, there was a mass in her uterus.Her doctor thought it could be remnants, damage from the essure procedure; she required surgery.She developed a chronic pain on her left side, and began developing ovarian cysts during her cycle that were painful to the point she ended up in the er because her doctor thought it had burst.Over the next year she steadily gained upwards of 29 pounds in spite of working out, and eating a 1400 calorie per day diet.She developed hypothyroidism.The chronic pain on her left side became disruptive.A ct scan revealed that her remaining essure coil appeared to be puncturing her uterus.A second surgery to investigate and subsequently remove her tubes occurred in (b)(6) 2015.She now struggles with a chronic health problem; still have pain in her left side.Follow up received on 28-oct-2015: ptc investigational result.Ptc global number: (b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because the possibility of detachment difficult event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The risk to the patient for these types of failure mode events were assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in the design fmea.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The reported medical event is a known, possible, undesirable event and not indicative of a quality defect per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer, who had excessive bleeding during essure (fallopian tube occlusion insert) insertion.One month later, she was submitted to a surgery due to an unspecified mass in her uterus (according to her doctor thought it could be remnants, damage from the essure procedure).Two years later, bilateral salpingectomy was performed as essure coil appeared to be puncturing her uterus at ct scan.Only uterine mass is unlisted according to essure's reference safety information.Uterine perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).If a perforation with essure occurs, patient may experience pain and bleeding during and after the procedure.In this case, consumer had pain and bleeding during essure insertion; additionally she stated the right coil unraveled and was not implanted.This suggests a difficult essure insertion; which may have contributed to the reported perforation (essure puncturing her uterus).Although the exact mechanism of the events was not known; given their nature causality with essure cannot be excluded.Regarding the reported uterine mass, limited information was provided for a comprehensive assessment.Therefore, causality with the suspect insert cannot be established.Additionally, non-serious events were reported.This case was regarded as incident, since device removal was required.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.No active follow-up will be pursued (case identified during health authority website monitoring).

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

Manufacturer Narrative

This case was initially received via regulatory authority (fda, reference number: fdafda-(b)(6)) on 04-oct-2015.The most recent information was received on 29-may-2020.This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('remaining essure coil appeared to be puncturing my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "during implantation right coil unraveled" in (b)(6) 2013, device deployment issue "during implantation right coil remained attached to the camera" in (b)(6) 2013 and device malfunction "device malfunction".In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), procedural haemorrhage ("excessive bleeding"), uterine mass ("mass in uterus/ her doctor thought it could be remnants, damage from the essure procedure"), procedural pain ("terribly painful"), pelvic pain ("chronic pain on left side"), ovarian cyst ("ovarian cysts during my cycle") with adnexa uteri pain, hypothyroidism ("developed hypothyroidism") with weight increased, migraine ("chronic migraine"), affective disorder ("mood disorder"), alopecia ("hair loss") and micturition disorder ("five times to pee").The patient was treated with surgery.Essure was removed in (b)(6) 2015.At the time of the report, the uterine perforation, procedural haemorrhage, uterine mass, procedural pain, ovarian cyst, hypothyroidism, migraine, affective disorder, alopecia and micturition disorder outcome was unknown and the pelvic pain had not resolved.The reporter considered affective disorder, alopecia, hypothyroidism, micturition disorder, migraine, ovarian cyst, pelvic pain, procedural haemorrhage, procedural pain, uterine mass and uterine perforation to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 29-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 case was initially received via regulatory authority (fda, reference number: (b)(4)) on 04-oct-2015.The most recent information was received on 12-jun-2020.This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('remaining essure coil appeared to be puncturing my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "during implantation right coil unraveled" in (b)(6) 2013, device deployment issue "during implantation right coil remained attached to the camera" in (b)(6) 2013 and device malfunction "device malfunction".In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), procedural haemorrhage ("excessive bleeding"), uterine mass ("mass in uterus/ her doctor thought it could be remnants, damage from the essure procedure"), procedural pain ("terribly painful"), pelvic pain ("chronic pain on left side"), ovarian cyst ("ovarian cysts during my cycle") with adnexa uteri pain, hypothyroidism ("developed hypothyroidism") with weight increased, migraine ("chronic migraine"), affective disorder ("mood disorder"), alopecia ("hair loss") and micturition disorder ("five times to pee").The patient was treated with surgery.Essure was removed in (b)(6) 2015.At the time of the report, the uterine perforation, procedural haemorrhage, uterine mass, procedural pain, ovarian cyst, hypothyroidism, migraine, affective disorder, alopecia and micturition disorder outcome was unknown and the pelvic pain had not resolved.The reporter considered affective disorder, alopecia, hypothyroidism, micturition disorder, migraine, ovarian cyst, pelvic pain, procedural haemorrhage, procedural pain, uterine mass and uterine perforation to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 12-jun-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 case was initially received via regulatory authority (fda, reference number: fda-(b)(4)) on 04-oct-2015.The most recent information was received on 20-mar-2020.This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('remaining essure coil appeared to be puncturing my uterus') and uterine mass ('mass in uterus/ her doctor thought it could be remnants, damage from the essure procedure') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "during implantation right coil remained attached to the camera" in (b)(6) 2013 and device use error "during implantation right coil unraveled" in (b)(6) 2013.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), procedural haemorrhage ("excessive bleeding"), uterine mass (seriousness criterion medically significant), procedural pain ("terribly painful"), pelvic pain ("chronic pain on left side"), ovarian cyst ("ovarian cysts during my cycle") with adnexa uteri pain, hypothyroidism ("developed hypothyroidism") with weight increased and migraine ("chronic migraine").The patient was treated with surgery.Essure was removed in (b)(6) 2015.At the time of the report, the uterine perforation, procedural haemorrhage, uterine mass, procedural pain, ovarian cyst, hypothyroidism and migraine outcome was unknown and the pelvic pain had not resolved.The reporter considered hypothyroidism, migraine, ovarian cyst, pelvic pain, procedural haemorrhage, procedural pain, uterine mass and uterine perforation to be related to essure.Quality-safety evaluation of ptc: final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because the possibility of detachment difficult event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The risk to the patient for these types of failure mode events were assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in the design fmea.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The reported medical event is a known, possible, undesirable event and not indicative of a quality defect per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media received: new events were added: chronic migraine and reporter information were updated.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type "initial" indicates here initial submission by the new legal manufacturer only.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 ('remaining essure coil appeared to be puncturing my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error "during implantation right coil unraveled" in march 2013, device deployment issue "during implantation right coil remained attached to the camera" in march 2013 and device malfunction "device malfunction".In march 2013, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), procedural haemorrhage ("excessive bleeding"), uterine mass ("mass in uterus/ her doctor thought it could be remnants, damage from the essure procedure"), procedural pain ("terribly painful"), pelvic pain ("chronic pain on left side"), ovarian cyst ("ovarian cysts during my cycle") with adnexa uteri pain, hypothyroidism ("developed hypothyroidism") with weight increased, migraine ("chronic migraine"), affective disorder ("mood disorder"), alopecia ("hair loss") and micturition disorder ("five times to pee").The patient was treated with surgery.Essure was removed in april 2015.At the time of the report, the uterine perforation, procedural haemorrhage, uterine mass, procedural pain, ovarian cyst, hypothyroidism, migraine, affective disorder, alopecia and micturition disorder outcome was unknown and the pelvic pain had not resolved.The reporter considered affective disorder, alopecia, hypothyroidism, micturition disorder, migraine, ovarian cyst, pelvic pain, procedural haemorrhage, procedural pain, uterine mass and uterine perforation to be related to essure.Quality-safety evaluation of ptc: final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time because the possibility of detachment difficult event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The risk to the patient for these types of failure mode events were assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in the design fmea.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The reported medical event is a known, possible, undesirable event and not indicative of a quality defect per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Further company follow-up with the regulatory authority or consumer is not possible.Amendment: the report was amended for the following reason: this is a retention case.All the information from deletion case (b)(4) (duplicate) including references has been transferred to this case.Social media received- new event mood disorder, device malfunction, hair loss and five time to pee were added.Reporter information was added.No new follow-up information was received from the reporter.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, CA 13353 ; GM 13353
• MDR Report Key: 5192970
• MDR Text Key: 30023996
• Report Number: 2951250-2015-01290
• Device Sequence Number: 1
• Product Code: HHS
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention