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

Model Number ESS305

Device Problems Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture') and device dislocation ('migration') in a female patient who had essure (batch no.50512921) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), mental disorder ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infections"), urinary tract infection ("uti"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (surgical removal of coils).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device dislocation, mental disorder, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection and vaginal discharge outcome was unknown.The reporter considered bladder disorder, cystitis, device breakage, device dislocation, mental disorder, urinary tract disorder, urinary tract infection, vaginal discharge and vaginal infection to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jan-2020: pif received.Event injury nos updated to device breakage.New events added: pelvic pain, psych injury, migration,bladder problem, urinary problem, bladder infections, uti, vaginal infections and vaginal discharge.Lot no.Added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture') and device dislocation ('migration') in a female patient who had essure (batch no.50512921) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), mental disorder ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infections"), urinary tract infection ("uti"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (surgical removal of coils).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device dislocation, mental disorder, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection and vaginal discharge outcome was unknown.The reporter considered bladder disorder, cystitis, device breakage, device dislocation, mental disorder, urinary tract disorder, urinary tract infection, vaginal discharge and vaginal infection to be related to essure.Lot number: 50512921, manufacture date: 2010-04, & expiration date: 2013-04.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-jun-2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracture') and device dislocation ('migration') in an adult female patient who had essure (batch no.50512921) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), mental disorder ("psych injury"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), cystitis ("bladder infections"), urinary tract infection ("uti"), vaginal infection ("vaginal infection") and vaginal discharge ("vaginal discharge").The patient was treated with surgery (surgical removal of coils).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, device dislocation, mental disorder, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection and vaginal discharge outcome was unknown.The reporter considered bladder disorder, cystitis, device breakage, device dislocation, mental disorder, urinary tract disorder, urinary tract infection, vaginal discharge and vaginal infection to be related to essure.The reporter commented: essure device was placed through the ostia without difficulty, deployed and 1 coil was noted on right and 0 coil noted on left side of the endometrial cavity.Lot number: 50512921, manufacture date: 2010-04, expiration date: 2013-04.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-may-2021: mr received: reporter information and rcc note added.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, 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: 10132893
• MDR Text Key: 194487552
• Report Number: 2951250-2020-08497
• 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,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2013
• Device Model Number: ESS305
• Device Lot Number: 50512921
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention