• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAYER PHARMA AG ESSURE INSERT, TUBAL OCCLUSION Back to Search Results
Model Number ESS305
Device Problem Device operates differently than expected
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Ptc investigation result was received on 19-sep-2015. This adverse event report is related to a product technical complaint (ptc). The bayer reference number for the ptc report is: 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: no product quality defect was confirmed therefore a relationship to the reported medical events and lack of efficacy is excluded. The technical assessment concluded unconfirmed quality defect. Based on the available information, there is no relationship between the reported medical events/lack of efficacy and a quality defect. Company causality comment: this non-medically confirmed, spontaneous report refers to a female consumer who became pregnant after essure insertion and lost her baby at (b)(6). Additionally, she stated she went to the hospital several times because of essure. She experienced rash due to nickel and unspecified cysts. These events were considered serious due to medical importance. Only cysts is unlisted in essure's reference safety information. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. Some of these pregnancies occurred due to patient non-compliance, which included failure to return for the essure confirmation test (hsg). In this case, no information was provided about hsg. However, as pregnancy occurred approximately 2 years after essure insertion, a contraceptive failure cannot be excluded. Regarding the reported fetal death at (b)(6), consumer stated the fetus had spina bifida (myelomeningocele) and water in his head (probably hydrocephalus). The etiology in most cases of myelomeningocele is multifactorial, involving genetic, racial, and environmental factors, in which nutrition, particularly folic acid intake, is a key. Spina bifida often occurs along with multiple congenital anomalies. In this case, the reported fetus anomalies could be alternative explanations for his death. For consumer's nickel allergy a causal relationship with essure cannot be excluded; due to event's nature and considering devices composition (essure insert consists of a nickel-titanium alloy which may cause allergic reactions). Since the cysts were not specified, causality with essure cannot be assessed. Additionally, non-serious events were reported. This case was regarded as incident, since according to the consumer, hospitalization was required. The technical assessment concluded unconfirmed quality defect. Based on the available information, there is no relationship between the reported medical events/lack of efficacy and a quality defect. No active follow-up will be pursued (case identified during health authority website monitoring).

 
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 (fda-2014-n-0736-0785, awareness date 27-aug-2015). It refers to a female consumer on unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in 2009 after the birth of her daughter. Consumer stated that in 2011, she was sick and felt like she had the flu. She went to her doctor who suggested a blood test which showed that she was pregnant. Few months later, she discovered that the baby had water in his head, hydropholous and also club feet spina bifida. She also had cramping, loss of hair, bloating, severe periods that last 8 days every month, arthritis in the knees, severe hives and rashes due to nickel, weight gain and so many more symptoms. She had been in and out of the hospital because of essure and because so many numerous cysts. She felt miserable, suffered and lost a lot of precious time because she had to stay in bed. She lost her baby at (b)(6) (case (b)(4)). She stated that she was about to have her hysterectomy at the age of (b)(6). Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who became pregnant after essure (fallopian tube occlusion insert) insertion and lost her baby at (b)(6). Additionally, she stated she went to the hospital several times because of essure. She experienced rash due to nickel and unspecified cysts. These events were considered serious due to medical importance. Only cysts is unlisted in essure's reference safety information. Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place. Some of these pregnancies occurred due to patient non-compliance, which included failure to return for the essure confirmation test (hsg). In this case, no information was provided about hsg. However, as pregnancy occurred approximately 2 years after essure insertion, a contraceptive failure cannot be excluded. Regarding the reported fetal death at (b)(6), consumer stated the fetus had spina bifida (myelomeningocele) and water in his head (probably hydrocephalus). The etiology in most cases of myelomeningocele is multifactorial, involving genetic, racial, and environmental factors, in which nutrition, particularly folic acid intake, is a key. Spina bifida often occurs along with multiple congenital anomalies. In this case, the reported fetus anomalies could be alternative explanations for his death. For consumer's nickel allergy a causal relationship with essure cannot be excluded; due to event's nature and considering devices composition (essure insert consists of a nickel-titanium alloy which may cause allergic reactions). Since the cysts were not specified, causality with essure cannot be assessed. Additionally, non-serious events were reported. This case was regarded as incident, since according to the consumer, hospitalization was required. No active follow-up will be pursued, as this case was identified during health authority website monitoring.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5085048
Report Number2951250-2015-00990
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2015
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 Received09/19/2015
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: 09/17/2015 Patient Sequence Number: 1
-
-