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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
Device Problems Break; Detachment of device or device component; Expulsion
Event Type  Injury  
Manufacturer Narrative

Follow-up received on 04-nov-2015: this case is a potential legal case now. Consumer stated that essure was inserted in 2008. She has been experiencing pain in her pelvis and had a test that revealed one of the coils came loose and is in her uterus. She also had headache and had a intercourse over the weekend and the condom broke. Consumer stated she is already suing essure and company. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who became pregnant after essure insertion and had a miscarriage. She stated essure broke off in her. Additionally, she had clots (regarded as genital bleeding) and went to the hospital due to breast infection. The consumer is suing essure and company (potential legal case). Miscarriage and breast infection are unlisted in essure's reference safety information, while the other events are listed. According to product technical analysis (ptc), device breakage is listed. 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. In this particular case, consumer stated she had tubal occlusion confirmed. Later, she informed essure broke off in her and came out. This device breakage could have been a contributory role in essure failure. However, since event's onset is unknown, an essure's contraceptive failure cannot be excluded. Regarding miscarriage it is the most common complication of early pregnancy, occurring in up to 20% of clinically recognized pregnancies at less than 20 weeks of gestation. Considering that a mechanical interference of essure in early developing pregnancy is unlikely, the reported event was considered as unrelated to the suspect insert. For the event clots; limited information was provided. Nevertheless, considering its nature, causality with essure cannot be excluded. Consumer also reported breast infection; which due to its nature was considered as unrelated to essure. This case was regarded as other reportable incident due to device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances. The ptc analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Additional information will be obtained through the normal litigation process.

 
Event Description

This is a spontaneous case report received from a female consumer of unspecified age in (b)(6) on 25-nov-2014 which who had essure (fallopian tube occlusion insert) inserted in 2008. She stated that was experiencing pain in her ovaries, fallopian tubes and waist ever since essure insertion. No further information was provided. Follow-up received by consumer on 11-dec-2014 the consumer stated that she had the test procedure done in 2009 to make sure that her tubes were blocked and she was told that they were blocked. She was still having pain in her ovaries. Product technical complaint investigation and final assessment were received on (b)(6) 2014: this adverse event report is related to a product technical complaint and was initiated due to a request for confirmation of quality. The bayer (b)(4) and the (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: this ptc was initiated due to a request for confirmation of quality. The reported adverse events are known possible undesirable events and not indicative of a quality deficit per se. The events were reported with an occurrence over 6 years. 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 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. Follow up information received on 25-jun-2015: consumer stated that she had pain sometimes in stomach near hip where wires are and sometimes in uterus when she is on her menstrual and also when it rains really bad. Follow-up information received from consumer on 17-jul-2015 consumer said that she had essure inserted and it broke off in her. She also stated that she had been pregnant and did not know it and she had a miscarriage. She had really bad pain and clots. No further information was provided. Case upgraded to other reportable incident. Ptc investigation result received on 24-jul-2015 ptc (b)(4) final assessment the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube. The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth. After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function. If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter. If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert. 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, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We were unable to confirm any quality defect or device malfunction at this time. The possibility of the micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device. Medical assessment this ptc was initiated due to a product technical issue and 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. Neither batch number nor complaint sample were available for further technical investigation. The technical assessment concluded unconfirmed quality defect. The reported adverse events considered related are known possible undesirable events and 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. In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Follow-up dated 24-jul-2015: upon follow up with the reporter; she confirmed that case (b)(4) wasn't about a friend it was a call about herself. She stated she had a miscarriage last month ((b)(6) 2015); and this wasn't supposed to happen because she had the test after the essure. She was in the hospital recently because she had a breast infection; she was treating with an antibiotic and a cream. She also reported she had her period three times last month. With this information, (b)(4) was identified as duplicate of this case. (b)(4) will be deleted from bayer database and the following information was added to this remaining case: on an unspecified date the consumer became pregnant with essure in place (device ineffective) since it had broken and came out. Ptc investigation result was received on 14-jul-2015. This adverse event report is related to a product technical complaint (ptc). The bayer reference number for the ptc report is: (b)(4). Final assessment: failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube. The inserts outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth. After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function. If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter. If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert. As of 6/29/2015, 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, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for. Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We were unable to confirm any quality defect or device malfunction at this time. The possibility of micro-insert breaking is an anticipated event. Medical assessment: this ptc was initiated due to a reported product quality issue. Neither batch number nor complaint sample was available for further technical investigation. The technical assessment concluded unconfirmed quality defect. The reported adverse event is a known possible undesirable event and not indicative of a quality deficit per se. The ae case refers also 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. 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. In summary, there is no reason to suspect a causal relationship to a potential quality deficit as based on this report. During internal review of information from 24-jul-2015 (from deleted case); the event essure came out was added under meddra pt device expulsion. Follow up 11-aug-2015: no new clinical information was provided. Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who became pregnant after essure insertion and had a miscarriage. She stated essure broke off in her. Additionally, she had clots (regarded as genital bleeding) and went to the hospital due to breast infection. Miscarriage and breast infection are unlisted in essure's reference safety information, while the other events are listed. According to product technical analysis (ptc), device breakage is listed. 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. In this particular case, consumer stated she had tubal occlusion confirmed. Later, she informed essure broke off in her and came out. This device breakage could have been a contributory role in essure failure. However, since event's onset is unknown, an essure's contraceptive failure cannot be excluded. Regarding miscarriage it is the most common complication of early pregnancy, occurring in up to 20% of clinically recognized pregnancies at less than 20 weeks of gestation. Considering that a mechanical interference of essure in early developing pregnancy is unlikely, the reported event was considered as unrelated to the suspect insert. For the event clots; limited information was provided. Nevertheless, considering its nature, causality with essure cannot be excluded. Consumer also reported breast infection; which due to its nature was considered as unrelated to essure. This case was regarded as other reportable incident due to device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances. The ptc analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report. Follow-up information is being sought.

 
Manufacturer Narrative

Data correction: the product 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 Key4999718
Report Number2951250-2015-00596
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation Other
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 Received08/13/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
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 Received03/29/2016
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: 08/13/2015 Patient Sequence Number: 1
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