MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Unspecified Infection (1930); Necrosis (1971); Pelvic Inflammatory Disease (2000); Renal Failure (2041); Septic Shock (2068); Toxic Shock Syndrome (2108)

Event Date 08/22/2013

Event Type  Death  

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fatal toxic shock syndrome streptococcal ('necrotizing group a streptococcus infection - streptococcal toxic shock syndrome'), uterine infection ('inflammatory infection'), uterine necrosis ('patient¿s cervix, fallopian tubes and uterus were necrotic') and fallopian tube necrosis ('patient¿s cervix, fallopian tubes and uterus were necrotic / female parts surrounding the essure were necrotic') in a (b)(6) year-old female patient who had essure inserted for female sterilisation. Medical conditions: (b)(6) 2013: pelvic exam - patient's cervix, fallopian tubes and uterus were necrotic. Blood cultures were positive for group a strep. On (b)(6) 2013, the patient had essure inserted. On (b)(6) 2013, the patient experienced toxic shock syndrome streptococcal (seriousness criteria death and hospitalization) with abdominal pain, disseminated intravascular coagulation and renal failure, 2 days after insertion of essure. On an unknown date, the patient experienced uterine infection (seriousness criterion medically significant), uterine necrosis (seriousness criterion medically significant) and fallopian tube necrosis (seriousness criterion medically significant). By the time of death, the uterine infection, uterine necrosis and fallopian tube necrosis outcome was unknown. The reported cause of death was streptococcal toxic shock syndrome, renal failure and disseminated intravascular coagulation. The reporter provided no causality assessment for fallopian tube necrosis, toxic shock syndrome streptococcal and uterine necrosis with essure. The reporter considered uterine infection to be related to essure. The reporter commented: the question of what caused her organs to die resulting in her ultimate death cannot be answered based on the report (conceptus number 2951250-2013-00017) and it is a coincidence that cannot be ignored. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc this case report refers to a (b)(6) year-old female patient who had inserted essure (fallopian tube occlusion insert) and experienced a fatal 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). Uterine infection is listed, while all other events are unlisted in the reference safety information for essure. 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. Considering the compatible temporal relationship (2 days after insertion) and no other plausible alternative explanation, the company considers causality between the events and essure insertion as related. Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

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

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

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: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• 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; p.o. box 915; whippany, NJ 07981-0915 ; 6509624238
• MDR Report Key: 3369777
• MDR Text Key: 191902488
• Report Number: 2951250-2013-00017
• 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,Company Representative,company representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2020

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

Device Operator

• 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