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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Sticking (1597); Expulsion (2933)

Patient Problems Anxiety (2328); Depression (2361)

Event Date 08/01/2012

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ("one of the essure micro-inserts had migrated and was embedded in her uterus") and embedded device ("essure micro-inserts had migrated and was embedded in her uterus") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.In (b)(6) 2009, the patient had essure inserted.In (b)(6) 2012, the patient experienced depression ("depression") and anxiety ("anxiety").On an unknown date, the patient experienced device expulsion (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, back pain ("severe lower back pain") and dyspareunia ("painful intercourse").The patient was treated with surgery (partial hysterectomy in (b)(6) 2012).At the time of the report, the device expulsion and embedded device had resolved and the back pain, dyspareunia, depression and anxiety outcome was unknown.The reporter considered anxiety, back pain, depression, device expulsion, dyspareunia and embedded device to be related to essure.The reporter commented: postoperatively, the doctor advised that he was able to remove one essure micro-insert that embedded in her uterus, the other micro-insert was still in her fallopian tube.Since her removal surgery, symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6) 2009, an hsg test was performed (result was not reported).Ultrasound scan vagina - in (b)(6) 2012: one essure migrated, embedded in uterus.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

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("essure micro-inserts had migrated and was embedded in her uterus/ coil rod was embedded in uterus") and device expulsion ("one of the essure micro-inserts had migrated and was embedded in her uterus/ migration of essure") in a 31-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: relistor, xanax and prozac.Concomitant products included amitriptyline since 2013, benzocaine (trocaine) since (b)(6) 2016, buspirone hydrochloride (buspar) since 2016, clonazepam (klonopin) since (b)(6) 2016, cyclobenzaprine hydrochloride (flexeril), escitalopram oxalate (lexapro) since 2015, medroxyprogesterone acetate (depo-provera) from (b)(6) 2009 to (b)(6) 2012, potassium chloride (klor-con) since (b)(6)2016, trazodone from 2012 to 2014, vicodin (norco) since 2015 to (b)(6) 2017 and trintellix since (b)(6) 2017.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced dyspareunia ("painful intercourse/ dyspareunia (painful sexual intercourse)").On (b)(6) 2012, the patient experienced depression ("depression") and anxiety ("anxiety").On (b)(6) 2012, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower and device expulsion (seriousness criteria medically significant and intervention required).On (b)(6)2013, the patient experienced migraine ("migraine") and headache ("headaches").On an unknown date, the patient experienced back pain ("severe lower back pain").The patient was treated with sumatriptan, surgery (in (b)(6) 2012, supracervical and partial hysterectomy).Essure was removed on (b)(6) 2012.At the time of the report, the embedded device and device expulsion had resolved and the back pain, dyspareunia, depression, anxiety, migraine and headache outcome was unknown.The reporter considered anxiety, back pain, depression, device expulsion, dyspareunia, embedded device, headache and migraine to be related to essure.The reporter commented: postoperatively, the doctor advised that he was able to remove one essure micro-insert that embedded in her uterus, the other micro-insert was still in her fallopian tube.Since her removal surgery, symptoms have mostly resolved, though some remain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: only one tube was occluded ultrasound scan vagina - in (b)(6) 2012: one essure migrated, embedded in uterus (b)(6) 2009, an hsg test was performed (result was not reported) most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received.New reporter added.Patient demographic added.Historical and concomitant medication added.Essure indication, start date updated and stop date added.New events migraine and headaches added.Event coil rod was embedded in uterus and dyspareunia (painful sexual intercourse) was clubbed with previously reported event.Lab data added.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: 6971143
• MDR Text Key: 90049744
• Report Number: 2951250-2017-05318
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE.; BUSPAR.; DEPO-PROVERA.; FLEXERIL.; KLONOPIN.; KLOR-CON.; LEXAPRO.; NORCO.; TRAZODONE.; TROCAINE.; UNCODEABLE "UNCLASSIFIABLE".
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 31 YR