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

Model Number ESS305

Device Problems Break (1069); Separation Failure (2547); Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a health professional and describes the occurrence of device breakage ("shattered coil") in a (b)(6)-year-old female patient who had essure (batch no.He013bj) inserted for female sterilisation.Other product or product use issues identified: device deployment issue "inset did not deploy correctly and is still inside patient" on (b)(6) 2018 and device difficult to use "it would not release from the end of the insertion device.".On (b)(6) 2018, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant).Essure treatment was not changed.At the time of the report, the device breakage outcome was unknown.The reporter provided no causality assessment for device breakage with essure.Most recent follow-up information incorporated above includes: on 31-dec-2018: follow up was received : new events, "device breakage, device difficult to use" were added.Incident.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a health professional and describes the occurrence of device deployment issue ("insert did not deploy correctly and is still inside patient/ device is not in fallopian tube, is inside uterus") and device difficult to use ("it would not release from the end of the insertion device.") in a 38-year-old female patient who had essure (batch no.He013bj) inserted for female sterilisation.The patient's medical history included body mass index normal.On (b)(6) 2018, the patient had essure inserted.The device deployment issue occurred on (b)(6) 2018.The device difficult to use occurred on an unknown date.Essure treatment was not changed.The reporter commented: patient was scheduled for laproscopic removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.2 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: device breakage questionnaire received.Case was downgraded to other event.Event "coil shattered" was deleted because it was confirmed in current follow-up that the device did not break.Event verbatim was updated as insert did not deploy correctly and is still inside patient/ device is not in fallopian tube, is inside uterus.Patient demographic information updated.Other relevant history updated.

Manufacturer Narrative

This spontaneous case was reported by a health professional and describes the occurrence of device breakage ("shattered coil") in a 38-year-old female patient who had essure (batch no.He013bj) inserted for female sterilisation.Other product or product use issues identified: device deployment issue "inset did not deploy correctly and is still inside patient" on 23-nov-2018 and device difficult to use "it would not release from the end of the insertion device.".On (b)(6) 2018 the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant).Essure treatment was not changed.At the time of the report, the device breakage outcome was unknown.The reporter provided no causality assessment for device breakage with essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-feb-2019: quality safety evaluation of product technical complaint.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary 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: 8238724
• MDR Text Key: 132760718
• Report Number: 2951250-2019-00309
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: ESS305
• Device Lot Number: HE013BJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 62