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

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('essure coil intact adherent and implanted into left wall of left cornua of uterus') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain ") and complication of device removal ("one essure coil still in the proximal tube and cornua area of the uterus on the patient's left side").The patient was treated with surgery (laparoscopic bilateral salpingectomy, essure removal).Essure was removed on (b)(6) 2019.At the time of the report, the embedded device, pelvic pain and complication of device removal outcome was unknown.The reporter considered complication of device removal, embedded device and pelvic pain to be related to essure.The reporter commented: more than one essure related surgery: yes date of essure related surgery: (b)(6) 2019 patient had laparoscopic bilateral salpingectomy done on (b)(6) 2019.At the time of the procedure, it was felt that she had complete removal of the essure device bilaterally, however, she continued to have left-sided pelvic pain and further investigation was performed and imaging revealed the presence of the essure coil still in the proximal tube and cornua area of the uterus on the patient's left side.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('essure coil intact adherent and implanted into left wall of left cornua of uterus') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("pelvic pain ") and complication of device removal ("one essure coil still in the proximal tube and cornua area of the uterus on the patient's left side").The patient was treated with surgery (laparoscopic bilateral salpingectomy, essure removal).Essure was removed on (b)(6) 2019.At the time of the report, the embedded device, pelvic pain and complication of device removal outcome was unknown.The reporter considered complication of device removal, embedded device and pelvic pain to be related to essure.The reporter commented: more than one essure related surgery: yes date of essure related surgery: (b)(6) 2019 patient had laparoscopic bilateral salpingectomy done on (b)(6) 2019.At the time of the procedure, it was felt that she had complete removal of the essure device bilaterally, however, she continued to have left-sided pelvic pain and further investigation was performed and imaging revealed the presence of the essure coil still in the proximal tube and cornua area of the uterus on the patient's left side.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 14-jul-2021: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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: 12141973
• MDR Text Key: 260687831
• Report Number: 2951250-2021-02822
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/14/2021

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 Model Number: ESS305
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 07/09/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention