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

Model Number ESS305

Event Date 08/26/2013

Event Type  Death  

Manufacturer Narrative

The medical opinion of the attending physician was that the cause of death was not directly related to the essure inserts or procedure.

Event Description

Patient had essure procedure (b)(6) 2013. Physician placed on essure device in patient's right and left fallopian tube. On (b)(6) 2013 patient went to emergency room with abdominal pain. Dr (b)(6) (who was not the implant doctor) performed a pelvic exam found the patient's cervix, fallopian tubes and uterus were necrotic. Patient had blood cultures, patient tested positive for group a strep infection. On (b)(6) 2013, patient went into renal failure and dic, patient passed way. On (b)(6) 2013, dr (b)(6) stated blood cultures were positive for group a strep and he believes the cause of death was related to necrotizing group a streptococcus infection (streptococcal toxic shock syndrome).

Manufacturer Narrative

Follow-up received on 02-may-2016: information was received from an article in august 2015. A doctor filed a report with fda medwatch adverse event reporting database about a woman who died during essure implantation due to necrotizing streptococcus spp. , and inflammatory infection associated with the device. Follow up request cannot be completed as there is no primary reporter contact information. Company causality comment: this spontaneous case report was received by a physician and refers to a (b)(6) female patient who had inserted essure (fallopian tube occlusion insert) and experienced necrotizing group a streptococcus infection - streptococcal toxic shock syndrome (abdominal pain, renal failure, and dic - disseminated intravascular coagulation); patient's cervix, fallopian tubes and uterus were necrotic and she also had inflammatory infection (seen as uterine infection). These events are unlisted in the reference safety information for essure. Streptococcal toxic shock syndrome was considered serious due to hospitalization and fatal outcome. Cervix, fallopian tubes and uterus were necrotic and inflammatory infection are considered serious due to medical importance. These events were regarded as incidents (fatal outcome). As with other gynecological or surgical procedures, severe infection can occur (including group a streptococcal sepsis) when microorganisms ascend from the lower genital tract, infecting the uterus, fallopian tubes and ovaries or following an unrecognized bladder or bowel injury occurred in association with the insertion procedure. 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. Based on the compatible temporal relationship and no other plausible alternative explanation, the company considers causality between the events and essure insertion as related. Follow up request cannot be completed as there is no primary reporter contact information.

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 ; GERMANY 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GERMANY 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany , NJ 07981-0915 ; 6509624238
• MDR Report Key: 3369777
• Report Number: 2951250-2013-00017
• Device Sequence Number: 1
• Product Code: HHS
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,COMPANY REPRESENTATIVE
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/18/2013
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: ESS305
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2016
• 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 TREATMENT DATA

Date Received: 09/18/2013 Patient Sequence Number: 1