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

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Abdominal Cramps (2543); Weight Changes (2607); Heavier Menses (2666)

Event Date 07/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") and genital haemorrhage ("abnormal bleeding (general)") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included labor induced (she was a week late, her son was stuck in the birth canal for 18 hours).Concurrent conditions included type ii diabetes mellitus and bipolar disorder.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), weight increased ("weight gain"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), migraine ("chronic migraines/ migraines"), headache ("headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vulvovaginal pain ("vaginal pain"), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2017, the patient experienced complication of device removal ("complications from essure removal procedure").On an unknown date, the patient experienced adnexa uteri pain ("severe pain in her ovaries").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, migraine, vaginal haemorrhage, menorrhagia, dysmenorrhoea and dyspareunia was resolving and the adnexa uteri pain, weight increased, nausea, headache, vulvovaginal pain and complication of device removal outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered adnexa uteri pain, dysmenorrhoea, dyspareunia, female sexual dysfunction, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.The reporter commented: as per pfs, discrepancy noted in essure removal date (b)(6) 2017 versus (b)(6) 2017.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion quality-safety evaluation of ptc: sample not available.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are known possible undesirable events and are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible no specific quality issue was define.Therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet received.Reporter information, patient¿s demographic information, relevant history and lab data updated.Essure removal date (b)(6) 2017 was added.Essure start date updated from (b)(6) 2014 to (b)(6) 2014.Events migraines was clubbed with previously reported event.Events genital haemorrhage, vaginal haemorrhage, menorrhagia, female sexual dysfunction, headache, nausea, dysmenorrhoea, dyspareunia, weight increased, vulvovaginal pain, complication of device removal were newly added.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.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain") and genital haemorrhage ("abnormal bleeding (general)") in a 26-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included labor induced (she was a week late, her son was stuck in the birth canal for 18 hours) and menometrorrhagia.Concurrent conditions included type ii diabetes mellitus inadequate control and bipolar disorder.Concomitant products included nortriptyline since 2015.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), weight increased ("weight gain"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), nausea ("nausea"), migraine ("chronic migraines/ migraines"), headache ("headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), vulvovaginal pain ("vaginal pain"), dysmenorrhoea ("dysmenorrhea (cramping)") and dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2017, 3 years 2 months after insertion of essure, the patient experienced complication of device removal ("complications from essure removal procedure").On an unknown date, the patient experienced adnexa uteri pain ("severe pain in her ovaries"), depression ("depression/ depressive disorder"), seizure ("seizures") and learning disability ("learning disability").The patient was treated with medroxyprogesterone (depo provera), levonorgestrel and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, migraine, vaginal haemorrhage, menorrhagia, dysmenorrhoea and dyspareunia was resolving and the adnexa uteri pain, weight increased, nausea, headache, vulvovaginal pain, complication of device removal, depression, seizure and learning disability outcome was unknown.The reporter provided no causality assessment for complication of device removal with essure.The reporter considered adnexa uteri pain, depression, dysmenorrhoea, dyspareunia, female sexual dysfunction, genital haemorrhage, headache, learning disability, menorrhagia, migraine, nausea, pelvic pain, seizure, vaginal haemorrhage, vulvovaginal pain and weight increased to be related to essure.The reporter commented: as per pfs, discrepancy noted in essure removal date (b)(6) 2017 versus (b)(6) 2017.Most, if not all symptoms decreased soon after removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: total bilateral occlusion.Essure confirmation test(s):essure coils were in place and looked good.Quality-safety evaluation of ptc: sample not available.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical events are known possible undesirable events and are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible no specific quality issue was define.Therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet received.Plaintiff demography added.Events- "learning disability, seizures, depression" , concomitant and treatment drugs added from pfs.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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: 7439625
• MDR Text Key: 105801758
• Report Number: 2951250-2018-01874
• 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
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NORTRIPTYLINE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 26 YR