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

Model Number ESS305

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Test Result (2695)

Event Date 04/10/2015

Event Type  Injury  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(6) 2015 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 for permanent sterilization (lot number c76446).Physician reported that per hysterosalpingogram done on (b)(6) 2015, no coils were found.The right side was blocked but there were no coils.Hcp (health care professional) said that the left side had no coils as well.Patient was in hospital on (b)(6) 2015 for lap (laparoscopy) with option to do tubal.No additional information was provided.The product technical complaint investigation and final assessment were received on (b)(4) 2015.(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 look for any manufacturing deficiencies.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.No new failure mode has been identified.Medical assessment: this product technical complaint was initiated due to a request for confirmation of quality.The reported adverse events is a known possible undesirable event and not indicative of a quality defect per se.No similar ae case reports have been received to date in relation to the reported batch.No batch signal could be identified.The batch documentation of the reported batch was reviewed.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 as based on this report.Ptc investigation result with correct case number was received on (b)(4) 2015.Lot number: c76446; production date: 7/2/2014 and expiration date: 7/31/2017.Ptc updated with case number without major changes.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that per hsg test, no coils found (right and left).This event was considered serious due to hospitalization 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, a hysterosalpingogram was performed about 4 months after essure insertion and the result showed no coils were found.The exact date and mechanism of dislocation were not known, however given its nature a causal relationship with essure therapy cannot be excluded.This case was regarded as incident due to hospitalization and required intervention (laparoscopy with option to do tubal).Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Further information is being sought.

Manufacturer Narrative

Follow up 04-aug-2015: the required number of follow up attempts have been completed, without response to date.No new information was provided.Case closed.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that per hsg test, no coils found (right and left).This event was considered serious due to hospitalization 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, a hysterosalpingogram was performed about 4 months after essure insertion and the result showed no coils were found.The exact date and mechanism of dislocation were not known, however given its nature a causal relationship with essure therapy cannot be excluded.This case was regarded as incident due to hospitalization and required intervention (laparoscopy with option to do tubal).Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.Further information could not be 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: 4780582
• MDR Text Key: 5880640
• Report Number: 2951250-2015-00327
• 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 Expiration Date: 07/31/2017
• Device Model Number: ESS305
• Device Lot Number: C76446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR