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

Model Number ESS305

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); Perforation (2001); Uterine Perforation (2121); Heavier Menses (2666); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pelvic pain") and uterine perforation ("left coil protruding from uterus on left cornua") in a female patient who received essure for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient started essure.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required), uterine perforation (seriousness criterion medically significant), dyspareunia ("painful intercourse") and menorrhagia ("excessive and abnormal bleeding during menstruation").Essure was withdrawn.At the time of the report, the pelvic pain, uterine perforation, dyspareunia and menorrhagia outcome was unknown.The reporter considered pelvic pain, uterine perforation, dyspareunia and menorrhagia to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2014: hysterosalpingogram result was satisfactory placement of both coils (normal).On (b)(6) 2016: laparoscopy result was left coil protruding from uterus on left cornua (abnormal nos).Company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced chronic pelvic pain.Approximately 3 years after insertion, she underwent hysterectomy with bilateral salpingectomy which revealed that the left coil was protruding from uterus on left cornua (seen as uterine perforation).These both events are anticipated in the reference safety information for essure.Chronic pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.The perforation of the uterus, fallopian tubes and internal bodily structures may occur during essure therapy due to insert migration or during insertion procedure (hysteroscopy or essure placement).In this present case, the exactly time point of uterine perforation was not reported and it was only diagnosed after hysteroscopy and bilateral salpingectomy.Based on the nature of this event, it was assessed as related to essure use.This case was regarded as incident since device removal was required.Other nonserious events were reported.A product technical analysis is being sought.No active follow-up is allowed and further information is expected only through litigation process.

Manufacturer Narrative

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.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 31-jan-2017: quality safety evaluation of ptc company causality comment: this spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion inserts) inserted and experienced chronic pelvic pain.Approximately 3 years after insertion, she underwent hysterectomy with bilateral salpingectomy which revealed that the left coil was protruding from uterus on left cornua (seen as uterine perforation).These both events are anticipated in the reference safety information for essure.Chronic pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between this event and suspect insert cannot be excluded.The perforation of the uterus, fallopian tubes and internal bodily structures may occur during essure therapy due to insert migration or during insertion procedure (hysteroscopy or essure placement).In this present case, the exactly time point of uterine perforation was not reported and it was only diagnosed after hysteroscopy and bilateral salpingectomy.Based on the nature of this event, it was assessed as related to essure use.This case was regarded as incident since device removal was required.Other nonserious events were reported.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.No active follow-up is allowed and further information is expected only through litigation process.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("left coil protruding from uterus on left cornua/ perforation (uterus)"), device expulsion ("migration of essure device (location of device: uterus)") and pelvic pain ("chronic pelvic pain/ pain") in an adult 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 miscarriage, multi gravida and parity 3 ((b)(6) 2009, (b)(6) 2012).Essure did not worsened a previously existing injury/condition.Previously administered products included for birth control: mirena in 2011 and nuvaring in 2010.Past adverse reactions to the above products included device issue with mirena.On (b)(6) 2013, the patient had essure inserted.In 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with uterine pain, device expulsion (seriousness criteria medically significant and intervention required) and menorrhagia ("excessive and abnormal bleeding during menstruation").The patient was treated with ibuprofen, surgery (total vaginal hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device expulsion, pelvic pain, dyspareunia and menorrhagia outcome was unknown.The reporter considered device expulsion, dyspareunia, menorrhagia, pelvic pain and uterine perforation to be related to essure.The reporter commented: on (b)(6) 2016, patient had laparoscopic surgery and found essure sticking out of uterus.She did not retain the essure device or any portion of it after essure removed.She had no complications from essure removal procedure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.4 kg/sqm.Laparoscopy - on (b)(6) 2016: left coil protruding from uterus on left cornua (abnormal nos) essure confirmation test on (b)(6) 2014, hysterosalpingogram (hsg), satisfactory placement of both coils, total bilateral occlusion.Current weight as of (b)(6) 2018: (b)(6) lbs.Approximate weight at the time of essure placement: (b)(6) lbs.On (b)(6) 2016, diagnostic laparoscopy procedure, findings: essure coil protruding from the uterus on the left cornua, normal ovaries, and no signs of endometriosis.The patient tolerated the procedure well.On (b)(6) 2016, she had total vaginal hysterectomy with bilateral salpingectomy procedure, findings: normal ovaries bilaterally both tubes removed.On (b)(6) 2016, surgical pathological report, gross description: a) labeled "uterus, cervix, and bilateral fallopian tubes" consists of a uterus with attached cervix and separate detached fimbriated fallopian tubes.The uterus and cervix weighs 70 grams, is 7.5 cm from fundus to cervix, 5 cm transversely and up to 3.5 cm in thickness.The ectocervix measures 3.2 cm in diameter with a 1.1 cm slit-like os.At the superior left fundus, approximately 1 cm from the fallopian tube orifice is a coil that was seen on the serosal surface that is embedded within the tissue.The coil seen on the right side was within the lumen of the stump of the fallopian tube and the left side found within the parenchyma and not grossly within the lumen of the stump of fallopian tube.The endometrium was lush pink measuring 0.2 cm in thickness.The myometrium was homogeneous pink with a mild to moderate trabeculation measuring up to 1.6 cm in thickness.One of the separate fimbriated fallopian tubes measures 3.5 cm in length x 0.6 cm in diameter.It has focal surface adhesions and an unremarkable stellate lumen on cut section.The opposite fimbriated fallopian tube was inked blue and measures 4 cm in length x 0.6 cm in diameter and has an unremarkable stellate lumen on cut section.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.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 23-jan-2018: plaintiff fact sheet and medical record received.Reporter information updated and case became medically confirmed.Patient¿s demographic information, relevant history and lab data updated.Events dyspareunia (painful sexual intercourse), pain, perforation (uterus) were clubbed with previously reported events.Events migration of essure device (location of device: uterus) and severe sporadic, then constant uterus pain were newly added.Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), 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.

• 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: 6269474
• MDR Text Key: 65504547
• Report Number: 2951250-2017-00226
• 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,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/23/2017
• Supplement Dates Manufacturer Received: Not provided; 01/23/2018
• Supplement Dates FDA Received: 02/21/2017; 01/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 52