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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Pain (1994); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/02/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of uterine perforation ("one coil migrated / found 1 coil went through the uterine wall") and device dislocation ("other one cannot be found / unable to find the other coil") in a (b)(6) female patient who had essure inserted for female sterilisation.In 2010, the patient had essure inserted.On (b)(6) 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and device dislocation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (took her tube and ovary on the side of the missing coil).At the time of the report, the uterine perforation and device dislocation had resolved.The reporter considered device dislocation and uterine perforation to be related to essure.The reporter commented: patient is doing fine.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 physician and describes the occurrence of uterine perforation ("one coil migrated / found 1 coil went through the uterine wall (left cornual region)"), device dislocation ("other one cannot be found / unable to find the essure in right tube") and genital haemorrhage ("bleeding") in a 39-year-old female patient who had essure inserted for female sterilisation.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not performed".The patient's past medical history included multigravida and parity 4.In may 2009, the patient had essure inserted.On (b)(6) 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and device dislocation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant).The patient was treated with surgery (took her tube and ovary on the side of the missing coil / hysteroscopic removal) and surgery (took her tube and ovary on the side of the missing coil / hysteroscopic removal).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation and device dislocation had resolved and the genital haemorrhage outcome was unknown.The reporter considered device dislocation, genital haemorrhage and uterine perforation to be related to essure.The reporter commented: patient is doing fine.Left essure visable and removed unable to locate right essure.Essure removal was medically necessary and was not removed because of patient request.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76.19 kgs.Hysteroscopy - on (b)(6) 2017: bilateral perforation (left cornual region) (b)(6) 2017: hysteroscopy: any organ or intra-abdominal structure were not perforated; unable to locate essure in right tube.Pathology results: there were no signs of infection and inflammation.Diagnostic laparoscopy: hysteroscopy with novasure ablation.Most recent follow-up information incorporated above includes: on (b)(6) 2018: uterine/tubal perforation with essure questionnaire was received and the following information was provided: patient¿s demographic details; essure insertion date was updated from 2010 to may-2009; removal date (b)(6) 2017; new lab data added; bleeding and essure confirmation test not performed were added as event.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

Ntaneous case was reported by a physician and describes the occurrence of uterine perforation ("one coil migrated / found 1 coil went through the uterine wall (left cornual region)"), device dislocation ("other one cannot be found / unable to find the essure in right tube") and genital haemorrhage ("bleeding") in a 39-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not performed".The patient's past medical history included multigravida and parity 4.In may 2009, the patient had essure inserted.On (b)(6) 2017, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant) and abdominal pain ("abdominal pain").The patient was treated with surgery (took her tube and ovary on the side of the missing coil / hysteroscopic removal) and surgery (took her tube and ovary on the side of the missing coil / hysteroscopic removal).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, device dislocation, genital haemorrhage and abdominal pain had resolved.The reporter considered abdominal pain, device dislocation, genital haemorrhage and uterine perforation to be related to essure.The reporter commented: patient is doing fine.Left essure visable and removed unable to locate right essure.Essure removal was medically necessary and was not removed because of patient request.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 76.19 kgs.Hysteroscopy - on (b)(6) 2017: bilateral perforation (left cornual region) (b)(6)2017: hysteroscopy: any organ or intra-abdominal structure were not perforated; unable to locate essure in right tube.Pathologgy results: there were no signs of infection and inflammation.Diagnostic laparoscopy: hysteroscopy with novasure ablation.Most recent follow-up information incorporated above includes: on (b)(6)2018: uterine/tubal perforation with essure questionnaire received: new event abdominal pain added.Outcome for the events genital haemorrhage and abdominal pain updated to recovered / resolved.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: 7056904
• MDR Text Key: 92885503
• Report Number: 2951250-2017-08497
• 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: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• 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: 08/10/2018
• 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: 76