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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Separation Failure (2547); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 12/14/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device breakage ("implant broke during laparoscopic removal") and device deployment issue ("implants inner part was hanging outside of the uterine cavity") in a female patient who received essure (batch no.He01186).The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device use error ("it looked like it is bent").On (b)(6) 2016, the patient started essure at an unspecified dose and frequency.On (b)(6) 2016, 1 day after starting essure, the patient experienced device deployment issue (serious criteria medically significant and clinically significant/intervention required), procedural pain ("pain during removal attempt") and device difficult to use ("not possible to remove the implant").On (b)(6) 2016, the patient experienced device breakage (serious criterion hospitalization) and complication of device removal ("implant broke during laparoscopic removal").The patient was treated with surgery (laparoscopy and the implant was removed).Essure was withdrawn.At the time of the report, the device breakage, device deployment issue, procedural pain, device difficult to use and complication of device removal outcome was unknown.The reporter provided no causality assessment for device breakage, device deployment issue, procedural pain, device difficult to use and complication of device removal with essure.Company causality comment: this spontaneous case report refers to a female patient who had essure inserted and, during insertion procedure, implant´s inner part was hanging outside of the uterine cavity (seen as device deployment issue).It was not possible to remove the insert immediately because patient had so much pain.Five days later, implant was removed via laparoscopy and, during removal procedure, it broke.Device deployment issue and device breakage are anticipated events in the reference safety information for essure.Other nonserious events were reported.Device deployment issues may occur during essure insertion procedure.In this present case, implant´s inner part was hanging outside of the uterine cavity after insertion and had to be removed four days later by laparoscopy (intervention required).Thus, based on the nature of this event, it was assessed as related to essure.Device breakage may occur during difficult insertion or removal procedures.In this particular case, the breakage occurred during a laparoscopic removal.Thus, also based on the nature of this event, it was also assessed as related to essure.This case was regarded as incident since device removal was required (intervention required).Further information is expected from reporter.A product technical analysis is being sought.

Manufacturer Narrative

Quality-safety evaluation of ptc: lot number he01186 (production date 01-oct-2015, expiration date 28-oct-2018).Based on complaint as reported, the complainant does not mention a malfunction or difficulty using the device.Since product was returned to us for this complaint, we were able to conduct an investigation of the retuned product.As received, we received two systems, the first device was never used and was still in the package, the second system was only the micro insert and we detected that the inner coil was stretched and the outer coil was broken.We did not receive the rest of the device to conduct the investigation.Due to the condition of the retuned micro-insert we were not able to investigate the bent tip.This complaint is an unconfirmed quality defect - but plausible due to the fact that we did not receive the complete device to conduct the investigation.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.We also conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.Possibility of bent tip and micro-insert breaking are anticipated events and mere was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue, device breakage and device shape alteration.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the medical event is a known, possible, undesirable event and not indicative of a quality deficit per se.A review of similar cases for this batch resulted in no unusual pattern identified.Most recent follow-up information incorporated above includes: on 24-jan-2017: quality safety evaluation of ptc.Company causality comment: a (b)(6) female patient had essure inserted and, during insertion procedure, implants inner part was bent visible on the side of uterine cavity (seen as device deployment issue).The inner coil of implant broke during insertion.A laparoscopy was performed and the implant was removed laparoscopically.However, a small part of implant´s spiral was left in tube.Device deployment issue and device breakage are anticipated events in the reference safety information for essure.Other nonserious events were reported.Device deployment issues may occur during essure insertion procedure.In this present case, implant´s inner part was hanging outside of the uterine cavity after insertion and had to be removed four days later by laparoscopy (intervention required).Thus, based on the nature of this event, it was assessed as related to essure.Device breakage may occur during difficult insertion or removal procedures.In this particular case, the breakage occurred during insertion procedure.Thus, also based on the nature of this event, it was also assessed as related to essure.This case was regarded as incident because device removal was required (intervention required).According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.No further information is expected.

Manufacturer Narrative

This spontaneous case was reported by a nurse and describes the occurrence of device breakage ("inner coil of implant broke during insertion") in a 40-year-old female patient who had essure (batch no.He01186) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device deployment issue "implants inner part was bent visible on the side of uterine cavity" (seriousness criteria medically significant and intervention required) on (b)(6) 2016.On (b)(6) 2016, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criteria medically significant and intervention required), procedural pain ("it was not possible to remove the implant immediately because patient had so much pain"), complication of device insertion ("inner coil of implant broke during insertion") and complication of device removal ("broken pieces were retrieved: a small part of implant´s spiral was left in tube").The patient was treated with surgery (laparoscopy, also the implant was removed laparoscopically on (b)(6) 2016) and surgery (the implant was removed laparoscopically on (b)(6) 2016).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, procedural pain, complication of device insertion and complication of device removal had resolved.The reporter provided no causality assessment for complication of device insertion, complication of device removal, device breakage and procedural pain with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.5 kg/sqm.On (b)(6) 2016: gynecological examination during essure placement: device breakage was diagnosed during insertion.The implant´s inner part was hanging outside of the uterine cavity.It looked like it was bent.3-4 spirals seen and according to this it seemed that it was in correct depth.No removal due to patient's pain.On (b)(6) 2016: hysteroscopy and laparoscopy with filshie clips for essure removal: a small part of implant´s spiral that was left in the tube was removed.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: 6246284
• MDR Text Key: 64715154
• Report Number: 2951250-2017-00135
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: ESS305
• Device Lot Number: HE01186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 66