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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a nurse in united states on (b)(4) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.Reporter stated that a patient's left coil was removed but the right coil could not be found by healthcare professional.Stated that it could not be detected via ultrasound but was detected via ct scan.Refused interview and follow up.Ptc investigation result was received on (b)(4) 2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: (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.The reported adverse events are known, possible, undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the (b)(4) database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further 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 medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and had left coil removed but the right coil could not be found, it could not be detected via ultrasound but was detected via ct scan.The reported event right coil could not be found, it could not be detected via ultrasound but was detected via ct scan was considered as suspicion of device migration.Both events were considered serious due to medical importance and listed for essure in the reference safety information.Sometimes migration through the fallopian tube is suspected, because the essure insert is found in the abdomen and no apparent perforation can be identified.In this case, it was unknown the exact location of right coil.It was not reported the reason why the left coil was removed.Also, the exact day of left coil removal and the type of surgery were unknown.Based on the information provided, a causal relationship between the reported events and suspect insert cannot be excluded.Although the reason for removal of left coil was not reported, this case was regarded as incident.According to product technical analysis, there is no reason to suspect a causal relationship to a potential quality deficit.The reporter refused interview.No further information will be requested.

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: 4226194
• MDR Text Key: 4997628
• Report Number: 2951250-2014-00471
• 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: Nurse
• 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: 10/08/2014
• Initial Date FDA Received: 11/05/2014
• 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