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

Model Number ESS305

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 11-nov-2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on an unspecified date.It was reported that patient had difficult essure placement.The reporter stated that there were no trailing coils.Then, she check the inserters and the coils were not present.An x-ray was done on the day of the placement and coils were present but not visible in the tubes.Five days later, a laparoscopy was done to do bilateral salpingectomy and coils were not in tubes upon removal or visualizable.Follow up information is not expected since reporter forbids further contact or interview.Ptc investigation result was received on 20-nov-2014.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.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.Medical assessment: this ptc was initiated due to a request for confirmation of quality.In addition, the ae case refers to a usability issue.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for a technical investigation.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit.Company causality comment: this spontaneous, medically confirmed case report refers to a female patient of unspecified age who had essure (fallopian tubes occlusion insert) inserted.The insertion was difficult and in the same day of placement, the x-ray showed that coils were present but not visible in the tubes.The event, interpreted as device dislocation, is serious due medical importance and listed in the reference safety information for essure.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 (distal fallopian tube or peritoneal cavity).In this case, during the difficult insertion procedure, the physician did not find the coils.She checked the inserters but the devices were not there.X-ray was performed and showed the coils were present but not visible in tubes.Then, five days later, a laparoscopy was done to perform bilateral salpingectomy and upon removal, the micro-inserts were not in tubes and were not visualized.Given the nature of the event, causality is assessed as related to essure use and since bilateral salpingectomy (serious injury) was performed, the case is regarded as incident.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided).Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Follow up information is not expected since reporter forbids further contact or interview.

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: 4305370
• MDR Text Key: 21835022
• Report Number: 2951250-2014-00509
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

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?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other