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

Model Number ESS305

Device Problems Break (1069); Difficult to Insert (1316); Separation Failure (2547); Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2017

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of device breakage ("the coil broke in half (coil 1st)") in a (b)(6) year-old female patient who had essure (batch no.He01336) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "after some difficulty, he was able to push the button, but then the coil did not detach so he tried to remove it" on (b)(6) 2017 and device use error "the tip of the coil was bent (coil 2)" on (b)(6) 2017.The patient's concurrent conditions included fallopian tube stenosis.On (b)(6) 2017, during attempt of essure insertion, the patient experienced device breakage (seriousness criterion medically significant), device deployment issue ("after some difficulty, he was able to push the button, but then the coil did not detach so he tried to remove it"), fallopian tube disorder ("irritation from first insertion attempt (coil 2nd)") and complication of device insertion ("hcp aborted the procedure").At the time of the report, the device breakage, device deployment issue, fallopian tube disorder and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and fallopian tube disorder with essure.The reporter commented: hcp was able to remove both pieces of essure.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 device breakage ("the coil broke in half (coil 1st)") in a (b)(6) year-old female patient who had essure (batch no.He01336) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "after some difficulty, he was able to push the button, but then the coil did not detach so he tried to remove it" on (b)(6) 2017 and device use error "the tip of the coil was bent (coil 2)" on (b)(6) 2017.The patient's concurrent conditions included fallopian tube stenosis.On an unknown date, the patient had essure inserted.On (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant), device deployment issue ("after some difficulty, he was able to push the button, but then the coil did not detach so he tried to remove it"), fallopian tube disorder ("irritation from first insertion attempt (coil 2nd)") and complication of device insertion ("hcp aborted the procedure").At the time of the report, the device breakage, device deployment issue, fallopian tube disorder and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue and fallopian tube disorder with essure.The reporter commented: hcp was able to remove both pieces of essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 09-jan-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.

Manufacturer Narrative

Ntaneous case was reported by a physician and describes the occurrence of device breakage ("the coil broke in half (coil 1st)") in a 42-year-old female patient who had essure (batch no.He01336) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "after some difficulty, he was able to push the button, but then the coil did not detach so he tried to remove it" on (b)(6) 2017, device difficult to use "after some difficulty, he was able to push the button, but then the coil did not detach so he tried to remove it" on (b)(6) 2017 and device use error "the tip of the coil was bent (coil 2)" on (b)(6) 2017.The patient's concurrent conditions included fallopian tube stenosis.On an unknown date, the patient had essure inserted.On (b)(6) 2017, the patient experienced device breakage (seriousness criterion medically significant), fallopian tube disorder ("irritation from first insertion attempt (coil 2nd)") and complication of device insertion ("hcp aborted the procedure").At the time of the report, the device breakage, fallopian tube disorder and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion, device breakage and fallopian tube disorder with essure.The reporter commented: hcp was able to remove both pieces of essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 8-oct-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: 7137282
• MDR Text Key: 96054312
• Report Number: 2951250-2017-10968
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Model Number: ESS305
• Device Lot Number: HE01336
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR