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U.S. Department of Health and Human Services

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

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BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS305
Event Type  Death  
Event Description

This is a spontaneous case report received from a consumer via social media in united states on 20-jan-2015 which refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted on an unspecified date. It was reported that essure lead to a death of a consumer during surgery for removal. Result and assessment of the product technical complaint investigation received on 22-jan-2015: 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 are no known death cases which were confirmed to be caused by essure. Medical assessment: this ptc was initiated due to a request for confirmation of quality. The reported adverse event is not indicative of a quality deficit per se and is considered not assessable by the company. 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. No complaint sample was provided 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. (b)(4). On 28-jan-2015, upon internal review, company reassessed death during surgery removal as related to essure. Follow-up information received on 28-jan-2015 and additional information received from product technical complaint (ptc) analysis on 30-jan-2015: consumer had 2 children. It was reported that the consumer died due to an embolism during a surgery to remove her reproductive organs. She had to undergo this procedure due to problems with essure. According to product technical complaint (ptc) analysis received, the symptoms/death reported could not be confirmed. Embolism and death are not related failure modes to essure. Company causality comment: this spontaneous case report received via social media refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and died of an embolism during a surgery to remove her reproductive organs. Consumer had to undergo this procedure (interpreted as hysterectomy) due to problems with essure. The reported event died of an embolism during a surgery to remove her reproductive organs was considered serious due to its fatal outcome and unlisted in the reference safety information for essure. The event interpreted as hysterectomy was considered serious due to medical importance and listed. Embolic events are known as possible complication of surgical procedures. This case was reported with limited information, neither type of embolism nor additional risk factors were provided. Although the exact reason for reproductive organs removal was not specified but it was mentioned that the procedure occurred due to problems with essure, a causal relationship between the reported events and suspect insert cannot be excluded. Thus, this case was regarded as incident due to the surgical intervention and fatal outcome. Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided). According to final assessment, embolism and death are not related failure modes to essure. Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product. No further information is expected.

 
Manufacturer Narrative

Follow-up information on 23-may-2016. Upon internal review, the case (b)(4) was identified as duplicate of this case. All relevant information was transferred to this remaining case. A legal claim was received and added to the case. This is a legal case now. Plaintiff was implanted with essure on or about (b)(6) 2010. After being implanted with essure, this plaintiff began to suffer from severe pelvic pain, numbness in extremities, severe long lasting migraines, and joint pain. Plaintiff had to have a hysterectomy as a result of essure and subsequently died. Company causality comment: this spontaneous case report initially received via social media refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and died of an embolism during a surgery to remove her reproductive organs. She experienced severe pelvic pain. She had to undergo a hysterectomy as a result of essure. The event surgery to remove her reproductive organs due to problems with essure was deleted. Upon receipt of follow-up, this case became legal. The reported event died of an embolism during a surgery to remove her reproductive organs was considered serious due to its fatal outcome and unlisted in the reference safety information for essure. The event severe pelvic pain is listed. Embolic events are known as possible complication of surgical procedures. This case was reported with limited information, neither type of embolism nor additional risk factors were provided. In this case, the exact reason for reproductive organs removal was due to pelvic pain. Based on the information provided, a causal relationship between the reported events and suspect insert cannot be excluded. Thus, this case was regarded as incident due to the surgical intervention and fatal outcome. Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect (no batch number was provided). According to final assessment, embolism and death are not related failure modes to essure. Medical ptc assessment considered that, based on the available information, there is no reason to suspect quality defect of the product. Further information will be obtained through the litigation process.

 
Manufacturer Narrative

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

 
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Brand NameESSURE
Type of DeviceINSERT, 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 Key4550870
Report Number2951250-2015-00137
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type Other,Consumer,CONSUMER,OTHER
Reporter Occupation Other
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 Received02/26/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberESS305
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 Received05/23/2016
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: 02/26/2015 Patient Sequence Number: 1
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