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

Model Number ESS305

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Death, Intrauterine Fetal (1855); Fever (1858); Internal Organ Perforation (1987); Perforation (2001); Pregnancy (3193)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (case# mw5036798) in united states on 04-aug-2014 who had essure (fallopian tube occlusion insert) inserted. On (b)(6) 2011, essure was inserted. In 2012, she became pregnant. In 2013, she had to deliver her son, but he had already died in utero three to four days prior (please refer to case number (b)(4)). In 2013, she went back in for surgery to have fallopian tubes removed. Upon awakening she was informed the essure on one side had migrated and perforated her uterus with a possibility of later puncturing her bowel. Therefore, she needed a hysterectomy. She went back under to have the hysterectomy, however, leaving ovaries. Three days later she was back in the hospital with a fever of 103. Nothing came of the fever. The date (b)(6) 2013 was reported as explant date. Death and life-threatening were selected by consumer as event report type and event outcome, respectively. However, it was not specified which event. No further information was provided. Follow-up information was received on 18-aug-2014: the required number of follow-up attempts has been made, with no response to date. Ptc investigation result was received on 22-aug-2014. This adverse event report is related to a product technical complaint (ptc). The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (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: the reported events are not indicative of a quality defect per se. In this particular case a lack of efficacy (pregnancy) was reported. A contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality deficit per se. No batch number was reported. Without this information neither a technical batch evaluation nor a batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible. No complaint sample was provided for further technical investigation. In summary, there is no suspicion of a quality defect based on the limited available information. Company causality comment: this non-medically confirmed, spontaneous case report, refers to a female consumer who had essure (fallopian tube occlusion insert) inserted; experienced a pregnancy with essure (device ineffective) and had to deliver her son who died in utero 3-4 days prior. She also stated that essure migrated and perforated uterus with possibility of bowel puncture. She was submitted to fallopian tubes removal and hysterectomy; and after this surgery was hospitalized due to fever. All above reported events, with exception of pregnancy, were considered serious (life-threatening- deliver of dead son, medical significance-perforation and hospitalization-fever) and incidents (required interventions/hospitalization). They are listed according to reference safety information for essure; except for fever and had to deliver her son who died in utero 3-4 days prior which are unlisted. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. In this particular case the consumer stated that she had to deliver her son who died in uterus, this event, interpreted as a fetal death was considered as related to essure, as a mechanical interference between the suspect insert and the developing pregnancy cannot be excluded. Regarding the event essure migrated and perforated uterus with possibility of bowel puncture; the perforation of the uterus, fallopian tubes and internal bodily structures may occur during essure therapy due to insert migration or during insertion procedure; therefore, this event was considered as related to essure. For the reported fever, as limited information was provided, causality cannot be assessed. According to product technical complaint investigation results, there is no suspicion of a quality defect based on the limited available 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 ; 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: 4051818
• MDR Text Key: 4814218
• Report Number: 2951250-2014-00352
• 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,Consumer,consumer,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/04/2014
• 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?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/02/2014 Patient Sequence Number: 1