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

Model Number ESS305

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Pregnancy (3193)

Event Date 06/08/2015

Event Type  No Answer Provided  

Event Description

This is a spontaneous case report received via regulatory authority (case# mw5043972) in united states on (b)(6) 2015 which refers to an infant female patient who was exposed to essure (fallopian tube occlusion insert) during her mother pregnancy (mother's linked case (b)(4)). The infant's mother became pregnant while relying on essure; complications from the device led to the death of the infant girl; (b)(6) 2015 was reported as event date. On 13-aug-2015, technical investigation result was received 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 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. There was no event reported which indicates a new technical failure mode for the device. Medical assessment: this ptc was initiated due to a request for confirmation of quality. The reported adverse events are not indicative of a quality deficit per se. No batch number was reported. Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible. Neither batch number nor complaint sample were available 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 based on this report. Company causality comment: this spontaneous and non-medically confirmed case report (received via regulatory authority) refers to a female infant whose mother had essure (fallopian tube occlusion insert) inserted, became pregnant probably due to device failure and had complications from device. These complications led the infant to death. This event is serious due to its fatal outcome and unlisted in the reference safety information for essure. In this case, limited information regarding to mother's pregnancy and infant's death have been provided. Considering that a mechanical interference of device in developing pregnancy cannot be totally excluded, this event is assessed as related to essure use and therefore this case is regarded as incident. Based on the available information, there is no reason to suspect quality defect of the product.

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: 5029394
• MDR Text Key: 24022387
• Report Number: 2951250-2015-00635
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ESS305
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/21/2015
• 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: 08/25/2015 Patient Sequence Number: 1