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

Model Number ESS305

Device Problems Activation, Positioning or Separation Problem (2906); Material Protrusion/Extrusion (2979)

Patient Problem Uterine Perforation (2121)

Event Date 11/30/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of uterine perforation ("perforated the patient with the scope/perforation occur before deployment / uterine perforation- fundal portion") in a (b)(6)-year-old female patient who had essure (batch no.(b)(4) inserted for female sterilisation.Other product or product use issues identified: device difficult to use "device insertion difficult".The patient's past medical history included multi gravida, parity 2, amenorrhea and spontaneous abortion.She had no ectopics or c sections.Previously administered products included for an unreported indication: propofol and contraception nos.Concurrent conditions included body mass index normal.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (laparoscopic salpingectomy at later time).At the time of the report, the uterine perforation was resolving.The reporter provided no causality assessment for uterine perforation with essure.The reporter commented: (b)(6) 2015 had iud for amenorrhea.She denied complaints immediately after insertion.Left essure was not attempted to be placed.Right essure was placed in correct position.The patient will be monitored.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6) kg/sqm.Hysteroscopy - on an unknown date: perforation.Laparoscopy - on an unknown date: perforation.She had no complaints immediately after insertion, position of essure in left tube: not attempted to be placed; position of essure in right tube: correct position.Most recent follow-up information incorporated above includes: on (b)(6) 2018: perforation questionnaire received: events ¿perforated the patient with the scope and inserted the delivery system on the left side, deployed the device the fore part of the micro insert was protruding out of the ostium¿, ¿so then she decided to pull out the whole micro system¿ and ¿deployed the device the fore part of the micro insert was protruding out of the ostium, so then she decided to pull out the whole micro system/the right side was not attempted to be insert¿ were deleted.Outcome was updated from "unknown" to "recovering / resolving".Patient details, other relevant history, lab data, relevant tests were added.Historical drug was 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

This spontaneous case was reported by a physician and describes the occurrence of uterine perforation ("perforated the patient with the scope/perforation occur before deployment / uterine perforation- fundal portion") in a 39-year-old female patient who had essure (batch no.E24122) inserted for female sterilisation.Other product or product use issues identified: device difficult to use "device insertion difficult".The patient's past medical history included multi gravida, parity 2, amenorrhea and spontaneous abortion.She had no ectopics or c sections.Previously administered products included for an unreported indication: propofol and contraception nos.Concurrent conditions included body mass index normal.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required).The patient was treated with surgery (laparoscopic salpingectomy at later time).At the time of the report, the uterine perforation was resolving.The reporter provided no causality assessment for uterine perforation with essure.The reporter commented: (b)(6) 2015 had iud for amenorrhea.She denied complaints immediately after insertion.Left essure was not attempted to be placed.Right essure was placed in correct position.The patient will be monitored.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.7 kg/sqm.Hysteroscopy - on an unknown date: perforation.Laparoscopy - on an unknown date: perforation.She had no complaints immediately after insertion, position of essure in left tube: not attempted to be placed; position of essure in right tube: correct position quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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.

• 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: 7171032
• MDR Text Key: 96585946
• Report Number: 2951250-2018-00199
• 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
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: ESS305
• Device Lot Number: E24122
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/08/2018
• Supplement Dates Manufacturer Received: 03/29/2018
• Supplement Dates FDA Received: 04/11/2018
• 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: 50