MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Mechanical Problem (1384); Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Heavier Menses (2666)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

Pt requiring surgical intervention to remove essure devices from bilateral fallopian tubes, as there was a mechanical complication indicated.The right fallopian tube noted to have essure extrusion near the comua during surgical procedure.Pt had essure placed 5-6 years ago, since placement pt experienced left lower quadrant abdominal pain, and heavy bleeding.Pt had a total laparoscopic hysterectomy, bilateral salpingectomy, left oophorectomy completed during surgical intervention.The pt also noted to have a cyst on left ovary during procedure.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 8471064
• MDR Text Key: 140684524
• Report Number: MW5085455
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR