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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Migration or Expulsion of Device (1395); Insufficient Information (3190); Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2012

Event Type  malfunction  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migrated implant"), device breakage ("suspicion that left coil had fractured") and genital haemorrhage ("unusual bleeding") in a female patient who had essure inserted.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, device breakage (seriousness criterion medically significant) and genital haemorrhage (seriousness criterion medically significant).At the time of the report, the device dislocation, device breakage and genital haemorrhage outcome was unknown.The reporter considered device breakage, device dislocation and genital haemorrhage to be related to essure.Diagnostic results: hsg : left coil had migrated and there was a suspicion that it had fractured.Right tube was occluded.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 device dislocation ("migrated implant"), device breakage ("suspicion that left coil had fractured") and genital haemorrhage ("unusual blleding") in a female patient who had essure inserted.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, device breakage (seriousness criterion medically significant) and genital haemorrhage (seriousness criterion medically significant).At the time of the report, the device dislocation, device breakage and genital haemorrhage outcome was unknown.The reporter considered device breakage, device dislocation and genital haemorrhage to be related to essure.Diagnostic results: hsg : left coil had migrated and there was a suspicion that it had fractured.Right tube was occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-jun-2018: quality-safety evaluation of ptc.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 device dislocation ("migrated implant/that your essure was not in the correct location in both"), device breakage ("suspicion that left coil had fractured") and genital haemorrhage ("unusual bleeding") in a female patient who had essure (batch no.A20055.A20066) inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included libido decreased.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), menstrual disorder ("unusual menstrual cycle"), fatigue ("fatigue"), dizziness ("dizziness"), headache ("headaches"), abdominal pain lower ("cramping") and abdominal pain ("abdominal pain").At the time of the report, the device dislocation, device breakage, genital haemorrhage, menstrual disorder, fatigue, dizziness, headache, abdominal pain lower and abdominal pain outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, device breakage, device dislocation, dizziness, fatigue, genital haemorrhage, headache and menstrual disorder to be related to essure.Diagnostic results: hsg : left coil had migrated and there was a suspicion that it had fractured.Right tube was occluded.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 17-sep-2018: pfs and medical record received:event unusual menstrual cycle, fatigue, dizziness, headaches, cramping, abdominal pain added.Reporters, lot number added.Incident: at the time of reporting, 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 device dislocation ("migrated implant/that your essure was not in the correct location in both"), device breakage ("suspicion that left coil had fractured") and genital haemorrhage ("unusual bleeding") in a female patient who had essure (batch no.A20055, a20066-inv) inserted.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included libido decreased.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant) with pelvic pain, device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), menstrual disorder ("unusual menstrual cycle"), fatigue ("fatigue"), dizziness ("dizziness"), headache ("headaches"), abdominal pain lower ("cramping") and abdominal pain ("abdominal pain").At the time of the report, the device dislocation, device breakage, genital haemorrhage, menstrual disorder, fatigue, dizziness, headache, abdominal pain lower and abdominal pain outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, device breakage, device dislocation, dizziness, fatigue, genital haemorrhage, headache and menstrual disorder to be related to essure.Diagnostic results: hsg : left coil had migrated and there was a suspicion that it had fractured.Right tube was occluded.Lot number a20066 is invalid.Lot number:a20055 manufacture date: 2012/06 expiration date: 2015/06.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-oct-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, 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

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('suspicion that left coil had fractured'), device dislocation ('migrated implant/that your essure was not in the correct location in both/device migration/essure device on the right could not be seen /essure that is probably in her abdomen') and device expulsion ('migrated implant/that your essure was not in the correct location in both/device migration/ one of the devices on the left has migrated mostly to the cavity of the uterus') in an adult female patient who had essure (batch no.A20055,a20066-inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "confirmed the essure is misplaced via xray".The patient's previously administered products included for an unreported indication: microgestin fe, paragard and yasmin.Concurrent conditions included libido decreased.On (b)(6) 2015, the patient had essure inserted.In (b)(6) 2012, the patient experienced abdominal pain lower ("cramping"), abdominal pain ("abdominal pain") and headache ("headaches").In (b)(6) 2012, the patient experienced genital haemorrhage ("unusual bleeding"), menstrual disorder ("unusual menstrual cycle"), fatigue ("fatigue") and dizziness ("dizziness").In (b)(6) 2012, the patient experienced device dislocation (seriousness criterion medically significant) and device expulsion (seriousness criterion medically significant) with pelvic pain.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant) and menorrhagia ("heavy periods").The patient was treated with levonorgestrel (mirena).Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, device expulsion, abdominal pain lower, abdominal pain, genital haemorrhage, menorrhagia, menstrual disorder, fatigue, dizziness and headache outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, device breakage, device dislocation, device expulsion, dizziness, fatigue, genital haemorrhage, headache, menorrhagia and menstrual disorder to be related to essure.The reporter commented: lot number a20066 is not valid.Lot number:a20055 manufacture date: 2012/06 expiration date: 2015/06 discrepancy: previous date of insertion (b)(6) 2012.Current date of insertion (b)(6) 2015.Legacy device report number - 2951250-2018-02308- medwatch 3500a mfr number.Diagnostic results: hsg : left coil had migrated and there was a suspicion that it had fractured.Right tube was occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-feb-2020: irms received.New events - heavy periods, one of the devices on the left has migrated mostly to the cavity of the uterus were added.Event of genital haemorrhage updated to non-serious.Date of insertion updated.New reporter was added.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.

• 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: 7531541
• MDR Text Key: 109377586
• Report Number: 2951250-2018-02308
• 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,Followup,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: ESS305
• Device Lot Number: A20055,A20066-INV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR