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

Model Number ESS305

Device Problems Break (1069); Fracture (1260)

Patient Problems Hair Loss (1877); Headache (1880); Pain (1994); Pelvic Inflammatory Disease (2000); Depression (2361); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), headache ("headaches"), depression ("depression") and alopecia ("hair loss").The patient was treated with surgery (to remove the essure).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, pelvic pain, headache, depression and alopecia outcome was unknown.The reporter considered alopecia, depression, device breakage, headache and pelvic pain to be related to essure.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 breakage ("fracturing of the implant") and pelvic infection ("infection (other) describe: pelvic") in a 42-year-old female patient who had essure (batch no.A34128) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain ("pain").In 2013, the patient experienced pelvic infection (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced alopecia ("hair loss").In 2015, the patient experienced gastritis ("gastrointestinal or digestive system condition type: gastritis").On (b)(6) 2016, 3 years 5 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced abdominal pain ("abdomen pain"), headache ("headaches"), depression ("depression"), vaginal infection ("vaginitis") and vulvovaginitis ("vulvovaginitis").The patient was treated with surgery (to remove the essure / bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, pelvic infection, pelvic pain, headache, depression, alopecia, gastritis, vaginal infection and vulvovaginitis outcome was unknown and the abdominal pain was resolving.The reporter considered abdominal pain, alopecia, depression, device breakage, gastritis, headache, pelvic infection, pelvic pain, vaginal infection and vulvovaginitis to be related to essure.The reporter commented: if you had your essure removed, did you retain the device or any portion of it? yes if yes, identify where essure device is being retained: unknown.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2016: breakage of essure device.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet was received - reporter and patient demographic added.The following events were provided: gastritis, pelvic infection, vaginitis, vulvovaginitis, abdomen pain.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

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant") and pelvic infection ("infection (other) describe: pelvic") in a 42-year-old female patient who had essure (batch no.A34128) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain ("pain").In 2013, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required).In (b)(6) 2013, the patient experienced alopecia ("hair loss").In 2015, the patient experienced gastritis ("gastrointestinal or digestive system condition type: gastritis").On (b)(6) 2016, 3 years 5 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced abdominal pain ("abdomen pain"), headache ("headaches"), depression ("depression"), vaginal infection ("vaginitis") and vulvovaginitis ("vulvovaginitis").The patient was treated with surgery (to remove the essure / bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, pelvic infection, pelvic pain, headache, depression, alopecia, gastritis, vaginal infection and vulvovaginitis outcome was unknown and the abdominal pain was resolving.The reporter considered abdominal pain, alopecia, depression, device breakage, gastritis, headache, pelvic infection, pelvic pain, vaginal infection and vulvovaginitis to be related to essure.The reporter commented: if you had your essure removed, did you retain the device or any portion of it? yes.If yes, identify where essure device is being retained: unknown.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2016: breakage of essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-aug-2018: quality-safety evaluation of product technical complaint.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

Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant") and pelvic infection ("infection (other) describe: pelvic") in a 42-year-old female patient who had essure (batch no.A34128) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In january 2013, the patient experienced pelvic pain ("pain").In 2013, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required).In december 2013, the patient experienced alopecia ("hair loss").In 2015, the patient experienced gastritis ("gastrointestinal or digestive system condition type: gastritis").On (b)(6) 2016, 3 years 5 months after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced abdominal pain ("abdomen pain"), headache ("headaches"), depression ("depression"), vaginal infection ("vaginitis"), vulvovaginitis ("vulvovaginitis") and pelvic discomfort ("discomfort").The patient was treated with surgery (to remove the essure / bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, pelvic infection, pelvic pain, headache, depression, alopecia, gastritis, vaginal infection, vulvovaginitis and pelvic discomfort outcome was unknown and the abdominal pain was resolving.The reporter considered abdominal pain, alopecia, depression, device breakage, gastritis, headache, pelvic discomfort, pelvic infection, pelvic pain, vaginal infection and vulvovaginitis to be related to essure.The reporter commented: if you had your essure removed, did you retain the device or any portion of it? yes if yes, identify where essure device is being retained: unknown.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion; on (b)(6) 2016: breakage of essure device on unknown date essure confirmation test total blockage; device breakage.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-oct-2018: plaintiff fact sheet received.Events added from pfs- discomfort.Lab data 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.

• 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: 7070779
• MDR Text Key: 93331473
• Report Number: 2951250-2017-09479
• 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
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Model Number: ESS305
• Device Lot Number: A34128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR