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

Model Number ESS305

Device Problem Microbial Contamination of Device (2303)

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

Event Date 12/20/2015

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2015.The patient had the essure inserted 10 days prior to the report (implying (b)(6) 2015) and went to physician's office on (b)(6) 2015 with flushing and severe pain.She says it is progressive since essure implantation.The physician thinks that it is related to an infection, and started her on 3 antibiotics.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and after 10 days went to the physicians office with flushing and severe pain.The physician thinks it was related to an infection.She was started on 3 antibiotics.This event, interpreted as a suspicion of pelvic infection, is serious due to medical significance and listed in the reference safety information for essure.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.In the present case, although the exact location of the infection was not clearly reported, based on the close temporal relationship with the insertion procedure and the therapy prescribed (3 antibiotics), it was interpreted as a pelvic infection.Given the nature of the event, the compatible temporal relationship and in the lack of an alternative explanation, causality with essure cannot be excluded.This case was regarded as incident since a serious injury was reported.A product technical analysis and further information are expected.

Manufacturer Narrative

Follow-up received on 15-feb-2016: product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint.The bayer reference number for the ptc report is (b)(4).Final assessment: 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.Medical assessment: based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.The reported medical events are not indicative of a quality deficit per se.Follow up 14-mar-2016: the doctor reported that pain appeared to have been secondary to infection.She responded to oral antibiotics for 14 days.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and after 10 days went to the physicians office with flushing and severe pain.The physician thinks it was related to an infection.She was started on 3 antibiotics.This event, interpreted as a suspicion of pelvic infection, is serious due to medical significance and listed in the reference safety information for essure.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.In the present case, although the exact location of the infection was not clearly reported, based on the close temporal relationship with the insertion procedure and the therapy prescribed (3 oral antibiotics), it was interpreted as a pelvic infection.Given the nature of the event, the compatible temporal relationship and in the lack of an alternative explanation, causality with essure cannot be excluded.This case was regarded as incident since a serious injury was reported.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.

Manufacturer Narrative

Follow up 14-mar-2016: the doctor reported that pain appeared to have been secondary to infection.She responded to oral antibiotics for 14 days.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and after 10 days went to the physicians office with flushing and severe pain.The physician thinks it was related to an infection.She was started on 3 antibiotics.This event, interpreted as a suspicion of pelvic infection, is serious due to medical significance and listed in the reference safety information for essure.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.In the present case, although the exact location of the infection was not clearly reported, based on the close temporal relationship with the insertion procedure and the therapy prescribed (3 oral antibiotics), it was interpreted as a pelvic infection.Given the nature of the event, the compatible temporal relationship and in the lack of an alternative explanation, causality with essure cannot be excluded.This case was regarded as incident since a serious injury was reported.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.

Manufacturer Narrative

Follow-up 16-may-2016: no further information is expected.Case considered closed.Company causality comment this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and after 10 days went to the physicians office with flushing and severe pain.The physician thinks it was related to an infection.She was started on 3 antibiotics.This event, interpreted as a suspicion of pelvic infection, is serious due to medical significance and listed in the reference safety information for essure.While essure system is sterile it may, due to a bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.This may explain an increased risk for pelvic infections after insertion procedure.In the present case, although the exact location of the infection was not clearly reported, based on the close temporal relationship with the insertion procedure and the therapy prescribed (3 oral antibiotics), it was interpreted as a pelvic infection.Given the nature of the event, the compatible temporal relationship and in the lack of an alternative explanation, causality with essure cannot be excluded.This case was regarded as incident since a serious injury was reported.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events and a quality defect.

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: 5396178
• MDR Text Key: 37000558
• Report Number: 2951250-2016-00049
• 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,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• 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: 05/16/2016
• 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