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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in united states on 31-mar-2016 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted 8 or 9 years ago for permanent contraception.Patient complained of chronic pelvic pain.On ultrasound, the physician thought was a strange finding.He did a d and c (dilation and curettage) and scoped patient.The physician could see essure coils coming out of both ostia.On right side there was some white inflammation or infection.No sample was taken since the physician was not sure if it was the coil or just inflammation.On left side there was a fibroid; he thought it looked like both ends of coil coming from tube.It might be the inner or outer coil or maybe coil was bent.The physician will probably perform hysterectomy in the future.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had chronic pelvic pain after essure (fallopian tube occlusion insert) insertion.She was scoped and submitted to a dilation and curettage.During this procedure, on the left side there was a fibroid and it looked like both ends of essure coil were coming from left tube; it might be the inner or outer coil (event regarded as device dislocation).On the right side, there was some white inflammation or infection.The physician will probably perform a hysterectomy.Only fibroid is unlisted 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) or dislocation (proximal/distal fallopian tube or peritoneal cavity) and can result in pelvic pain.In this particular case, the patient had a uterine fibroid on the left side.This fibroid could have been a contributory role in the reported device dislocation.However, considering events nature causality with the suspect insert cannot be excluded.The same assessment is given for the reported suspicion of inflammation and infection (since a mechanical action of the dislocated essure within the uterine cavity cannot be excluded).The reported fibroids were considered as unrelated to essure, based on device safety profile and event's pathophysiology.This case was regarded as incident, since a surgical intervention was performed (scope and d and c) and a hysterectomy was planned.A product technical analysis and follow-up information are being sought.

Manufacturer Narrative

Quality safety evaluation received on 16-may-2016: (b)(4).Per complaint as reported, the description relates more to device shape alteration.The description does not describes a breakage of the micro insert.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.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 chronic pelvic pain after essure (fallopian tube occlusion insert) insertion.She was scoped and submitted to a dilation and curettage.During this procedure, on the left side there was a fibroid and it looked like both ends of essure coil were coming from left tube; it might be the inner or outer coil (event regarded as device dislocation).On the right side, there was some white inflammation or infection.The physician will probably perform a hysterectomy.Only fibroid is unlisted 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) or dislocation (proximal/distal fallopian tube or peritoneal cavity) and can result in pelvic pain.In this particular case, the patient had a uterine fibroid on the left side.This fibroid could have been a contributory role in the reported device dislocation.However, considering events nature causality with the suspect insert cannot be excluded.The same assessment is given for the reported suspicion of inflammation and infection (since a mechanical action of the dislocated essure within the uterine cavity cannot be excluded).The reported fibroids were considered as unrelated to essure, based on device safety profile and event's pathophysiology.This case was regarded as incident, since a surgical intervention was performed (scope and d&c) and a hysterectomy was planned.The product technical complaint investigation resulted in an unconfirmed quality defect.Follow-up information is being sought.

Manufacturer Narrative

Follow-up from 13-jul-2016: follow-up attempts have been completed, with no response to date.No further follow-up will be pursued.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had chronic pelvic pain after essure (fallopian tube occlusion insert) insertion.She was scoped and submitted to a dilation and curettage.During this procedure, on the left side there was a fibroid and it looked like both ends of essure coil were coming from left tube; it might be the inner or outer coil (event regarded as device dislocation).On the right side, there was some white inflammation or infection.The physician will probably perform a hysterectomy.Only fibroid is unlisted 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) or dislocation (proximal/distal fallopian tube or peritoneal cavity) and can result in pelvic pain.In this particular case, the patient had a uterine fibroid on the left side.This fibroid could have been a contributory role in the reported device dislocation.However, considering events nature causality with the suspect insert cannot be excluded.The same assessment is given for the reported suspicion of inflammation and infection (since a mechanical action of the dislocated essure within the uterine cavity cannot be excluded).The reported fibroids were considered as unrelated to essure, based on device safety profile and event's pathophysiology.This case was regarded as incident, since a surgical intervention was performed (scope and d&c) and a hysterectomy was planned.The product technical complaint investigation resulted in an unconfirmed quality defect.Further information could not be obtained, despite follow-up attempts.

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: 5609233
• MDR Text Key: 43760441
• Report Number: 2951250-2016-00425
• 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: health professional,other
• Reporter Occupation: Physician
• 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

• Date FDA Received: 04/26/2016
• 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?: Yes
• Date Manufacturer Received: 07/13/2016
• 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