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

Model Number ESS305

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Internal Organ Perforation (1987); Pain (1994); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ("perforation of organs") and device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), dyspareunia ("painful intercourse") and pelvic pain ("pain").The patient had surgery to remove the essure implant (b)(6) 2016.At the time of the report, the perforation, device breakage, dyspareunia and pelvic pain outcome was unknown.The reporter considered device breakage, dyspareunia, pelvic pain and perforation to be related to essure.The reporter commented: patient need for additional surgery.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 perforation ("perforation of organs") and device breakage ("fracturing of the implant") in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included overweight.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) (type: uti's)").In (b)(6) 2013, the patient experienced dyspareunia ("painful intercourse/dyspareunia (painful sexual intercourse)"), pelvic pain ("pain"), depression ("psychological or psychiatric problems (condition: depression)"), migraine ("migraines"), headache ("headaches"), dysmenorrhoea ("dysmenorrhea (cramping)") and fatigue ("fatigue").In (b)(6) 2015, the patient experienced weight increased ("weight gain").On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required) and abdominal pain ("pain: abdomen").The patient was treated with paracetamol (tylenol), ibuprofen (advil), surgery (had surgery to remove the essure implant/bilateral salpingectomy) and surgery (had surgery to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the perforation, device breakage, dyspareunia, urinary tract infection, depression, migraine, headache, dysmenorrhoea, fatigue and weight increased outcome was unknown and the pelvic pain and abdominal pain had resolved.The reporter considered abdominal pain, depression, device breakage, dysmenorrhoea, dyspareunia, fatigue, headache, migraine, pelvic pain, perforation, urinary tract infection and weight increased to be related to essure.The reporter commented: patient need for additional surgery.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 27.5 kg/sqm.Hysterosalpingogram - in (b)(6) 2014: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 1-oct-2018: pfs received with her demographic conditions.Following events were added: infection (bladder/ urinary tract/vaginal) (type: uti's), psychological or psychiatric problems (condition: depression), migraines, headaches, dysmenorrhea (cramping), fatigue and weight gain and abdominal pain.Event pt updated: painful intercourse/dyspareunia (painful sexual intercourse).Treatment drugs added.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: 7079401
• MDR Text Key: 93615634
• Report Number: 2951250-2017-09754
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 73