MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Loss of Range of Motion (2032)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a consumer (she is a other health professional) via regulatory authority (case# mw5061368) in united states on (b)(6) 2016 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014.She stated that she was working and started having horrible abdominal pain to which she could not even stand up straight.She went to emergency room and her doctor decided to do a laparoscopy to find out the problem.He discovered that the essure had protruded out the side of fallopian tube and other essure was hanging out the bottom of the other tube.Essure was removed on (b)(6) 2014.She received fluoxetine as concomitant medication.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and an exploratory laparoscopy showed one essure had protruded out the side of fallopian tube and other essure was hanging out the bottom of the other tube.The devices were removed.These events were considered serious due to their medical importance and are listed according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes; this movement could be an expulsion (into uterus or out of the body), dislocation (into the distal fallopian tube or peritoneal cavity) or occur as a result of a fallopian tube perforation during insertion.In this particular case, the consumer developed abdominal pain after essure insertion and was submitted to a laparoscopy.During this surgery, both devices were found out of place.Essure was removed 5.5 months after its placement.Although the exact mechanism of the events is not known; given their nature, causality with essure cannot be excluded.This case was regarded as incident, since device removal was required.Follow-up information and product technical analysis are being sought.

Manufacturer Narrative

Quality-safety evaluation of product technical complaint (ptc): received on 27-may-2016: ptc global number (b)(4).For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.There was no event reported which indicates a new technical failure mode for the device.The ptc investigation was initiated and the outcome of the investigation resulted in an unconfirmed quality defect.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and an exploratory laparoscopy showed one essure had protruded out the side of fallopian tube and other essure was hanging out the bottom of the other tube.The devices were removed.These events were considered serious due to their medical importance and are listed according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes; this movement could be an expulsion (into uterus or out of the body), dislocation (into the distal fallopian tube or peritoneal cavity) or occur as a result of a fallopian tube perforation during insertion.In this particular case, the consumer developed abdominal pain after essure insertion and was submitted to a laparoscopy.During this surgery, both devices were found out of place.Essure was removed 5.5 months after its placement.Although the exact mechanism of the events is not known; given their nature, causality with essure cannot be excluded.This case was regarded as incident, since device removal was required.The product technical complaint analysis resulted in an unconfirmed quality defect.Further information has been requested.

Manufacturer Narrative

Follow-up received on 24-jun-2016: follow-up attempts were done with no response to date.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and an exploratory laparoscopy showed one essure had protruded out the side of fallopian tube and other essure was hanging out the bottom of the other tube.The devices were removed.These events were considered serious due to their medical importance and are listed according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes; this movement could be an expulsion (into uterus or out of the body), dislocation (into the distal fallopian tube or peritoneal cavity) or occur as a result of a fallopian tube perforation during insertion.In this particular case, the consumer developed abdominal pain after essure insertion and was submitted to a laparoscopy.During this surgery, both devices were found out of place.Essure was removed 5.5 months after its placement.Although the exact mechanism of the events is not known; given their nature, causality with essure cannot be excluded.This case was regarded as incident, since device removal was required.The product technical complaint analysis resulted in an unconfirmed quality defect.Despite follow-up attempts, no further information was obtained.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5673273
• MDR Text Key: 45764366
• Report Number: 2951250-2016-00660
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/16/2016; 07/19/2016; 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention