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

Model Number ESS205

Device Problem No Information

Event Type  Injury  

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting taking place in september 2015. This is a spontaneous case report received from a regulatory authority ((b)(4)) in united states on 06-aug-2015 which refers to a fetus whose mother of unspecified age had essure (fallopian tube occlusion insert) inserted in 2006. The mother had severe complications which led to a complete hysterectomy at almost (b)(6)weeks pregnant. The fetus died (mother's case (b)(4)). Company causality comment: this non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus. At (b)(6) weeks of consumer's pregnancy, she was submitted to a hysterectomy due to severe complications (unspecified) and the fetus died. The reported event was considered serious due to fatal outcome and is unlisted according to essure's reference safety information. In this particular case, limited information was provided. The complications experienced by the mother were not specified and no information was provided about fetal disorders. Nevertheless, considering the fetus died during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded. Therefore, the reported event was considered as possibly related to the suspect insert. A product technical analysis is being sought. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Product technical complaint investigation and final assessment were received on (b)(6)2015: (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 lack of efficacy. A contraceptive failure may occur with the use of any contraceptive and is not indicative of a quality deficit per se. 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 was available for a 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 non-medically confirmed, spontaneous case report was received from a female consumer and refers to her fetus; who was exposed to essure (fallopian tube occlusion insert) in uterus. At 20 weeks of consumer's pregnancy, she was submitted to a hysterectomy due to severe complications (unspecified) and the fetus died. The reported event was considered serious due to fatal outcome and is unlisted according to essure's reference safety information. In this particular case, limited information was provided. The complications experienced by the mother were not specified and no information was provided about fetal disorders. Nevertheless, considering the fetus died during the second trimester of gestation; a mechanical interference between essure and the developing pregnancy cannot be excluded. Therefore, the reported event was considered as possibly related to the suspect insert. In this case neither batch number nor complaint sample were available for a 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. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Internal correction on 24-nov-2015. During internal review it was notified that the previously reported initial receipt date 06-aug-2015 is incorrect. The correct initial receipt date of the case is 09-aug-2015.

• 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
• MDR Report Key: 5041671
• Report Number: 2951250-2015-00668
• Device Sequence Number: 1
• Product Code: HHS
• Report Source: Manufacturer
• Source Type: CONSUMER,HEALTH PROFESSIONAL
• Type of Report: Initial,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: 08/31/2015
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: ESS205
• Was Device Available For Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/24/2015
• 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: 08/31/2015 Patient Sequence Number: 1