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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problems Break; Biocompatibility ; Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 01/01/2015
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.

 
Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), pelvic pain ("severe pelvic pain") and allergy to metals ("allergic to nickel / hypersensitivity reaction to nickel / heavy metal toxicity poisoning") in a female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included parity 2 (gravida 3 para 2 - deliveries on (b)(6) 2002 and (b)(6) 2003), abortion, allergy to metals and migraine (plaintiff developed worsening migraines as a result of the essure implantation. ). Concomitant products included cilest (sprintec) in 2010 for birth control, diclofenac in 2014 for inflammation, joint pain and joint swelling, ondansetron on (b)(6) 2014 for nausea, lidocaine on (b)(6) 2014 for pain in hip and pain and hydrocodone in (b)(6) 2015, ibuprofen in (b)(6) 2015 and tramadol in (b)(6) 2015 for postoperative pain. On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), arthralgia ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("numbess in extremities / numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth") and migraine ("severe long lasting migraines / worsening migraines as a result of the essure implantation / excruciating painful worsening migraines"). On an unknown date, the patient experienced pulmonary embolism (seriousness criterion death), pelvic pain (seriousness criteria medically significant and intervention required), nausea ("nausea / mild to severe nausea"), mental disorder ("aggravated psychiatric and/or psychological conditions / mental anguish") and adverse event ("physical injuries"). The patient was treated with surgery (hysterectomy on (b)(6) 2015). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the arthralgia, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, allergy to metals, nausea, mental disorder and adverse event outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism. The reporter considered adverse event, allergy to metals, arthralgia, dysgeusia, hypoaesthesia, mental disorder, migraine, nausea, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. Plaintiff had suffered symptoms consistent with heavy metal toxicity poisoning and her cause of death was listed as "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" her hysterectomy surgery to remove the essure device. After essure removal, mental anguish and suffering associated with her physical injuries improved. Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure device was broken. (b)(6) 2011 - essure confirmation test (no results available). (b)(6) 2013 - nickel test for allergy - positive unspecified date: x-ray - showed that the e. Ssure device was broken, however, it was not possible to see if there was any perforation. Quality-safety evaluation of ptc: 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. The symptoms/death reported could not be confirmed. Embolism and death are not related failure modes to 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. Most recent follow-up information incorporated above includes: on 4-dec-2017: plaintiff fact sheet and medical records received. Death date reported. Concomitant drugs and medical history updated. Events updated and added: stabbing, excruciating and radiating pain in her right side and hip, tingling and numbness in her right foot, metallic taste in mouth, allergic to nickel, aggravated psychiatric and/or psychological conditions, physical injuries and mild to severe nausea. Incident: no lot number or sample available for investigation. There is no evidence that a device related defect or malfunction caused a death or serious injury. If additional information becomes available it will be provided on a supplemental report.

 
Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), pelvic pain ("severe pelvic pain") and allergy to metals ("allergic to nickel / hypersensitivity reaction to nickel / heavy metal toxicity poisoning") in a female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included parity 2 (gravida 3 para 2 - deliveries on (b)(6) 2002 and (b)(6) 2003), abortion, allergy to metals and migraine (plaintiff developed worsening migraines as a result of the essure implantation. ). Concomitant products included cilest (sprintec) since 2010 to (b)(6) 2011 for birth control, diclofenac since 2014 for inflammation, joint pain and joint swelling, ondansetron since (b)(6) 2014 for nausea, lidocaine since (b)(6) 2014 for pain in hip and pain and hydrocodone since (b)(6) 2015, ibuprofen since (b)(6) 2015 and tramadol since (b)(6) 2015 for postoperative pain. On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), pain ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("numbness in extremities / numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth") and migraine ("severe long lasting migraines / worsening migraines as a result of the essure implantation / excruciating painful worsening migraines"). On an unknown date, the patient experienced pulmonary embolism (seriousness criterion death), pelvic pain (seriousness criteria medically significant and intervention required), nausea ("nausea / mild to severe nausea"), mental disorder ("aggravated psychiatric and/or psychological conditions / mental anguish"), injury ("physical injuries") and malaise ("extremely sick"). The patient was treated with surgery (hysterectomy on (b)(6) 2015). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the pain, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, allergy to metals, nausea, mental disorder, injury and malaise outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism. The reporter considered allergy to metals, dysgeusia, hypoaesthesia, injury, malaise, mental disorder, migraine, nausea, pain, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. Plaintiff had suffered symptoms consistent with heavy metal toxicity poisoning and her cause of death was listed as "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" her hysterectomy surgery to remove the essure device. After essure removal, mental anguish and suffering associated with her physical injuries improved. Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure device was broken. On (b)(6) 2011 - essure confirmation test (no results available). On (b)(6) 2013 - nickel test for allergy - (b)(6). Unspecified date: x-ray - showed that the essure device was broken, however, it was not possible to see if there was any perforation. Quality-safety evaluation of ptc: 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. The symptoms/death reported could not be confirmed. Embolism and death are not related failure modes to 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. Most recent follow-up information incorporated above includes: on 25-jun-2018: information such as event malaise, source document and references transferred from the duplicate deletion case 2018-137174. Incident this case report was initially received via social media and further information was received through litigation process. The case refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced severe pelvic pain and allergy to nickel. She had to undergo a hysterectomy as a result of the severe pelvic pain. As a consequence of the surgical procedure she had a pulmonary embolism (fatal outcome). The reported event pulmonary embolism is unanticipated in the reference safety information for essure, while pelvic pain and allergy to nickel are anticipated. Embolic events are known as possible complication of surgical procedures. In this case, the reproductive organs removal was attributed 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.

 
Manufacturer Narrative

"ntaneous" case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), pelvic pain ("severe pelvic pain") and allergy to metals ("allergic to nickel / hypersensitivity reaction to nickel / heavy metal toxicity poisoning") in a female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included parity 2 (gravida 3 para 2 - deliveries on (b)(6)), abortion, allergy to metals and migraine (plaintiff developed worsening migraines as a result of the essure implantation. ). Concomitant products included cilest (sprintec) since 2010 to (b)(6) 2011 for birth control, diclofenac since 2014 for inflammation, joint pain and joint swelling, ondansetron since (b)(6) 2014 for nausea, lidocaine since (b)(6) 2014 for pain in hip and pain and hydrocodone since (b)(6) 2015, ibuprofen since (b)(6) 2015 and tramadol since (b)(6) 2015 for postoperative pain. On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), pain ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("numbness in extremities / numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth"), nausea ("nausea / mild to severe nausea"), migraine ("severe long lasting migraines / worsening migraines as a result of the essure implantation / excruciating painful worsening migraines") and arthralgia ("pain in her right side and hip"). On an unknown date, the patient experienced pulmonary embolism (seriousness criterion death), pelvic pain (seriousness criteria medically significant and intervention required), anxiety ("aggravated psychiatric and/or psychological conditions / mental anguish"), injury ("physical injuries") and malaise ("extremely sick/ not feeling well"). The patient was treated with surgery (hysterectomy on (b)(6) 2015). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the pain, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, allergy to metals, nausea, anxiety, injury, malaise and arthralgia outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism. The reporter considered allergy to metals, anxiety, arthralgia, dysgeusia, hypoaesthesia, injury, malaise, migraine, nausea, pain, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. Plaintiff had suffered symptoms consistent with heavy metal toxicity poisoning and her cause of death was listed as "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" her hysterectomy surgery to remove the essure device. After essure removal, mental anguish and suffering associated with her physical injuries improved. Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure device was broken. On (b)(6) 2011 - essure confirmation test (no results available). On (b)(6) 2013 - nickel test for allergy - positive. Unspecified date: x-ray - showed that the essure device was broken, however, it was not possible to see if there was any perforation. Quality-safety evaluation of ptc: 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. The symptoms/death reported could not be confirmed. Embolism and death are not related failure modes to 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. Most recent follow-up information incorporated above includes: on 7-aug-2018: new reporter added. New event added: pain in her right side and hip. Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer. Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only. Incident. No lot number or sample available for investigation. There is no evidence that a device-related defect or malfunction caused a death or serious injury. If additional information becomes available it will be provided on a supplemental report.

 
Manufacturer Narrative

"ntaneous" case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), fatal intracardiac thrombus ("right cardiac thrombosis"), fatal eosinophilia ("peripheral eosinophilia"), pelvic pain ("severe pelvic pain"), device breakage ("x-ray showed that the essure device was broken"), allergy to metals ("allergic to nickel / hypersensitivity reaction to nickel/heavy metal toxicity poisoning") and metal poisoning ("heavy metal toxicity syndrome") in an adult female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included parity 2 (gravida 3 para 2 - deliveries on (b)(6) 2002 and (b)(6) 2003), abortion and migraine (plaintiff developed worsening migraines as a result of the essure implantation. ). Patient never had a nickel test before her symptoms started in (b)(6) 2013. Concurrent conditions included obesity. Concomitant products included cilest (sprintec) since 2010 to (b)(6) 2011 for birth control and hydrocodone since (b)(6) 2015, ibuprofen since (b)(6) 2015 and tramadol since (b)(6) 2015 for postoperative pain. On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), pain ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("numbess in extremities/numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth"), nausea ("nausea / mild to severe nausea"), migraine ("severe long lasting migraines/worsening migraines as a result of the essure implantation / excruciating painful worsening migraines") and arthralgia ("pain in her right side and hip"). On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), anxiety ("aggravated psychiatric and/or psychological conditions/mental anguish"), injury ("physical injuries"), metal poisoning (seriousness criterion medically significant) and malaise ("extremely sick/ not feeling well"). In (b)(6) 2015, the patient experienced pulmonary embolism (seriousness criterion death), intracardiac thrombus (seriousness criterion death) and eosinophilia (seriousness criterion death). The patient was treated with ondansetron, diclofenac, lidocaine and surgery (hysterectomy on (b)(6) 2015 to remove essure). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the pain, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, device breakage, allergy to metals, nausea, anxiety, injury, metal poisoning, malaise and arthralgia outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism, intracardiac thrombus and eosinophilia. The reporter considered allergy to metals, anxiety, arthralgia, device breakage, dysgeusia, eosinophilia, hypoaesthesia, injury, intracardiac thrombus, malaise, metal poisoning, migraine, nausea, pain, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. A week after essure removal, the patient stated that she had not felt that well in years and appeared to make an improvement/after essure removal, mental anguish and suffering associated with her physical injuries improved. On numbness, she came home after a long day of driving and complained of not feeling well and went to bed. She was found in her bed at approximately 11:00 a. M. The autopsy revealed the cause of death to be "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" to her hysterectomy surgery to remove the essure device. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34. 7 kg/sqm. X-ray - on an unknown date: essure device was broken. (b)(6) 2011 - essure confirmation test (no results available). (b)(6) 2013 - nickel test for allergy - positive. Unspecified date: x-ray - showed that the essure device was broken, however, it was not possible to see if there was any perforation. Quality-safety evaluation of ptc: 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. The symptoms/death reported could not be confirmed. Embolism and death are not related failure modes to 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. Most recent follow-up information incorporated above includes: on 1-nov-2018: all source documents and reference section from deletion case (b)(4) were transferred to this case (b)(4). Incident: a (b)(6) year-old female patient received insertion of essure fallopian tube occlusion insert for contraception. Approx. 2. 5 years after insertion, she began to suffer from severe, radiating pelvic pain and numerous other events, including nickel allergy and device breakage. Analgesics remained ineffective therefore essure was removed by hysterectomy after approx. 4 years of use. Some events rapidly regressed, but 2 weeks post surgery, immediately after a long drive, the patient developed a fatal pulmonary embolism associated with intracardiac thrombosis and peripheral eosinophilia. Pain events, device breakage, and nickel allergy are anticipated events according to the reference safety information of essure, whereas the fatal events are unanticipated. Pain, device breakage, and allergy are part of the known safety profile of essure, therefore in this particular case a causality of essure for these events cannot be excluded (related). Regarding the thromboembolism, the patient had multiple independent risk factors of obesity, recent surgical intervention, and very recent long-haul traveling. However, since the surgery had become necessary to remove essure, and considering that the peripheral eosinophilia (mentioned in the causality chain of the thromboembolism) may have been caused or aggravated by the nickel allergy, a causal or contributory role of essure in these conditions cannot be excluded (related). No lot number or sample available for investigation. There is no evidence that a device-related defect or malfunction caused a death or serious injury. If additional information becomes available it will be provided on a supplemental report. No lot number or sample was available for investigation. There is no evidence that a device-related defect or malfunction caused a death or serious injury. If additional information becomes available it will be provided on a supplemental report.

 
Manufacturer Narrative

"ntaneous" case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), fatal intracardiac thrombus ("right cardiac thrombosis"), fatal eosinophilia ("peripheral eosinophilia"), pelvic pain ("severe pelvic pain"), device breakage ("x-ray showed that the essure device was broken"), allergy to metals ("allergic to nickel / hypersensitivity reaction to nickel / heavy metal toxicity poisoning") and metal poisoning ("heavy metal toxicity syndrome") in an adult female patient who had essure inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included (b)(6) ((b)(6) - deliveries on (b)(6) 2002 and (b)(6) 2003), abortion and migraine (plaintiff developed worsening migraines as a result of the essure implantation). Patient never had a nickel test before her symptoms started in (b)(6) 2013. Concurrent conditions included obesity. Concomitant products included cilest (sprintec) since 2010 to (b)(6) 2011 for birth control and hydrocodone since (b)(6) 2015, ibuprofen since (b)(6) 2015 and tramadol since (b)(6) 2015 for postoperative pain. On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), pain ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("'numbess' in extremities / numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth"), nausea ("nausea / mild to severe nausea"), migraine ("severe long lasting migraines / worsening migraines as a result of the essure implantation / excruciating painful worsening migraines") and arthralgia ("pain in her right side and hip"). In (b)(6) 2015, the patient experienced pulmonary embolism (seriousness criterion death), intracardiac thrombus (seriousness criterion death) and eosinophilia (seriousness criterion death). On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), anxiety ("aggravated psychiatric and/or psychological conditions / mental anguish"), injury ("physical injuries"), metal poisoning (seriousness criterion medically significant) and malaise ("extremely sick/ not feeling well"). The patient was treated with ondansetron, diclofenac, lidocaine and surgery (hysterectomy on (b)(6) 2015 to remove essure). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the pain, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, device breakage, allergy to metals, nausea, anxiety, injury, metal poisoning, malaise and arthralgia outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism, intracardiac thrombus and eosinophilia. The reporter considered allergy to metals, anxiety, arthralgia, device breakage, dysgeusia, eosinophilia, hypoaesthesia, injury, intracardiac thrombus, malaise, metal poisoning, migraine, nausea, pain, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. A week after essure removal, the patient stated that she had not felt that well in years and appeared to make an improvement / after essure removal, mental anguish and suffering associated with her physical injuries improved. On (b)(6) 2015, she came home after a long day of driving and complained of not feeling well and went to bed. She was found in her bed at approximately 11:00 a. M. The autopsy revealed the cause of death to be "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" to her hysterectomy surgery to remove the essure device. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34. 7 kg/sqm. X-ray - on an unknown date: essure device was broken. (b)(6) 2011 - essure confirmation test (no results available). (b)(6) 2013 - nickel test for allergy - positive. Unspecified date: x-ray - showed that the essure device was broken; however, it was not possible to see if there was any perforation. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 8-nov-2018: quality-safety evaluation of product technical complaint. Incident: a (b)(6) female patient received insertion of essure fallopian tube occlusion insert for contraception. Approx. 2. 5 years after insertion, she began to suffer from severe, radiating pelvic pain and numerous other events, including nickel allergy and device breakage. Analgesics remained ineffective; therefore, essure was removed by hysterectomy after approx. 4 years of use. Some events rapidly regressed, but 2 weeks post surgery, immediately after a long drive, the patient developed a fatal pulmonary embolism associated with intracardiac thrombosis and peripheral eosinophilia. Pain events, device breakage, and nickel allergy are anticipated events according to the reference safety information of essure, whereas the fatal events are unanticipated. Pain, device breakage, and allergy are part of the known safety profile of essure, therefore in this particular case a causality of essure for these events cannot be excluded (related). Regarding the thromboembolism, the patient had multiple independent risk factors of obesity, recent surgical intervention, and very recent long-haul traveling. However, since the surgery had become necessary to remove essure, and considering that the peripheral eosinophilia (mentioned in the causality chain of the thromboembolism) may have been caused or aggravated by the nickel allergy, a causal or contributory role of essure in these conditions cannot be excluded (related). No lot number or sample was available for investigation. There is no evidence that a device-related defect or malfunction caused a death or serious injury. If additional information becomes available it will be provided on a supplemental report.

 
Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), fatal intracardiac thrombus ("right cardiac thrombosis"), fatal eosinophilia ("peripheral eosinophilia"), pelvic pain ("severe pelvic pain"), device breakage ("x-ray showed that the essure device was broken"), allergy to metals ("allergic to nickel / hypersensitivity reaction to nickel / heavy metal toxicity poisoning"), metal poisoning ("heavy metal toxicity syndrome") and fatal cardiac arrest ("cardiac arrest") in an adult female patient who had essure (batch no. Dj11115) inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's medical history included parity (b)(6) (gravida (b)(6) para (b)(6) - deliveries on (b)(6) 2002 and (b)(6) 2003), abortion, migraine (plaintiff developed worsening migraines as a result of the essure implantation. ), hair growth increased, polycystic ovarian syndrome, back pain, tonsillectomy, menopausal hot flushes and unresponsive to stimuli. Patient never had a nickel test before her symptoms started in (b)(6) 2013. On (b)(6) 2011 - essure confirmation test (no results available). On (b)(6) 2013 - nickel test for allergy - positive. On unspecified date: x-ray- showed that the essure device was broken; however, it was not possible to see if there was any perforation. Previously administered products included for an unreported indication: yaz. Concurrent conditions included obesity, abdominal pain, dysmenorrhea, left lower quadrant pain, follicular cyst of ovary, menopausal diaphoresis, insomnia, pneumonia, endocervical squamous metaplasia, benign fallopian tube neoplasm, bleeding menstrual heavy, dyspareunia, depression, anxiety, muscle weakness, vision blurred, ringing in ears, headache, rash, difficulty breathing and respiration abnormal. Concomitant products included ethinylestradiol;norgestimate (sprintec) since 2010 to (b)(6) 2011 for birth control, hydrocodone since (b)(6) 2015, ibuprofen since (b)(6) 2015 and tramadol since (b)(6) 2015 for postoperative pain as well as propofol (anesthesia s/i 60). On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), pain ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("'numbess' in extremities / numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth"), nausea ("nausea / mild to severe nausea"), migraine ("severe long lasting migraines / worsening migraines as a result of the essure implantation / excruciating painful worsening migraines") and arthralgia ("pain in her right side and hip"). In (b)(6) 2015, the patient experienced pulmonary embolism (seriousness criterion death), intracardiac thrombus (seriousness criterion death) and eosinophilia (seriousness criterion death). On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), anxiety ("aggravated psychiatric and/or psychological conditions / mental anguish"), injury ("physical injuries"), metal poisoning (seriousness criterion medically significant), malaise ("extremely sick/ not feeling well") and cardiac arrest (seriousness criterion death). The patient was treated with diclofenac, lidocaine, ondansetron and surgery (hysterectomy on (b)(6) 2015 to remove essure). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the pain, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, device breakage, allergy to metals, nausea, anxiety, injury, metal poisoning, malaise and arthralgia outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism, intracardiac thrombus, eosinophilia and cardiac arrest. The reporter considered allergy to metals, anxiety, arthralgia, cardiac arrest, device breakage, dysgeusia, eosinophilia, hypoaesthesia, injury, intracardiac thrombus, malaise, metal poisoning, migraine, nausea, pain, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. A week after essure removal, the patient stated that she had not felt that well in years and appeared to make an improvement / after essure removal, mental anguish and suffering associated with her physical injuries improved. On (b)(6) 2015, she came home after a long day of driving and complained of not feeling well and went to bed. She was found in her bed at approximately 11:00 a. M. The autopsy revealed the cause of death to be "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" to her hysterectomy surgery to remove the essure device. Number of coils: left: 3; right: 3. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34. 7 kg/sqm. Dehydroepiandrosterone test - on an unknown date: negative. Pregnancy test - on an unknown date: negative. Ultrasound pelvis - on an unknown date: normal. X-ray - on an unknown date: results: essure device was broken. Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records : migraines, pelvic pain, joint pain, pain, dysgeusia and dyspnoea. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 4-jan-2019: mr received. Reporter information were added. Event: cardiac arrest were added. Cause of death were added. Medical history, historical drug, concomitant drug and lab data were added. Incident: a (b)(6) female patient received insertion of essure fallopian tube occlusion insert for contraception. Approx. 2. 5 years after insertion, she began to suffer from severe, radiating pelvic pain and numerous other events, including nickel allergy and device breakage. Analgesics remained ineffective; therefore, essure was removed by hysterectomy after approx. 4 years of use. Some events rapidly regressed, but 2 weeks post surgery, immediately after a long drive, the patient developed a fatal pulmonary embolism associated with intracardiac thrombosis, peripheral eosinophilia and cardiac arrest. Pain events, device breakage, and nickel allergy are anticipated events according to the reference safety information of essure, whereas the fatal events are unanticipated. Pain, device breakage, and allergy are part of the known safety profile of essure, therefore in this particular case a causality of essure for these events cannot be excluded (related). Regarding the thromboembolism and the associated complications, the patient had multiple independent risk factors of obesity, recent surgical intervention, and very recent long-haul traveling. However, since the surgery had become necessary to remove essure, and considering that the peripheral eosinophilia (mentioned in the causality chain of the thromboembolism) may have been caused or aggravated by the nickel allergy, a causal or contributory role of essure in these conditions cannot be excluded (related). No lot number or device sample was received in this case. We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

 
Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fatal pulmonary embolism ("pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia"), fatal intracardiac thrombus ("right cardiac thrombosis"), fatal eosinophilia ("peripheral eosinophilia"), fatal cardiac arrest ("cardiac arrest"), pelvic pain ("severe pelvic pain"), device breakage ("x-ray showed that the essure device was broken"), allergy to metals ("allergic to nickel/hypersensitivity reaction to nickel/heavy metal toxicity poisoning") and metal poisoning ("heavy metal toxicity syndrome") in an adult female patient who had essure (batch no. Dj11115-not valid) inserted for female sterilisation. The occurrence of additional non-serious events is detailed below. The patient's medical history included parity 2 (gravida 3 para 2 - deliveries on (b)(6) 2002 and (b)(6) 2003), abortion, migraine (plaintiff developed worsening migraines as a result of the essure implantation. ), hair growth increased, polycystic ovarian syndrome, back pain, tonsillectomy, menopausal hot flushes and unresponsive to stimuli. Patient never had a nickel test before her symptoms started in (b)(6) 2013. (b)(6) 2011 - essure confirmation test (no results available). (b)(6) 2013 - nickel test for allergy - positive. Unspecified date: x-ray - showed that the essure device was broken, however, it was not possible to see if there was any perforation. Previously administered products included for an unreported indication: yaz. Concurrent conditions included obesity, abdominal pain, dysmenorrhea, left lower quadrant pain, follicular cyst of ovary, menopausal diaphoresis, insomnia, pneumonia, endocervical squamous metaplasia, benign fallopian tube neoplasm, bleeding menstrual heavy, dyspareunia, depression, anxiety, muscle weakness, vision blurred, ringing in ears, headache, rash, difficulty breathing and respiration abnormal. Concomitant products included ethinylestradiol; norgestimate (sprintec) since 2010 to (b)(6) 2011 for birth control, hydrocodone since (b)(6) 2015, ibuprofen since (b)(6) 2015 and tramadol since (b)(6) 2015 for postoperative pain as well as propofol (anesthesia s/i 60). On (b)(6) 2010, the patient had essure inserted. In (b)(6) 2013, the patient experienced allergy to metals (seriousness criterion medically significant), pain ("stabbing, excruciating and radiating pain in her right side and hip"), paraesthesia ("tingling in her right foot (stabbing, excruciating and radiating pain)"), hypoaesthesia ("numbess in extremities/numbness in her right foot (stabbing, excruciating and radiating pain)"), dysgeusia ("metallic taste in mouth"), nausea ("nausea / mild to severe nausea"), migraine ("severe long lasting migraines/worsening migraines as a result of the essure implantation/excruciating painful worsening migraines") and arthralgia ("pain in her right side and hip"). In (b)(6) 2015, the patient experienced pulmonary embolism (seriousness criterion death), intracardiac thrombus (seriousness criterion death) and eosinophilia (seriousness criterion death). On an unknown date, the patient experienced cardiac arrest (seriousness criterion death), pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), anxiety ("aggravated psychiatric and/or psychological conditions/mental anguish"), injury ("physical injuries"), metal poisoning (seriousness criterion medically significant) and malaise ("extremely sick/not feeling well"). The patient was treated with diclofenac, lidocaine, ondansetron and surgery (hysterectomy on (b)(6) 2015 to remove essure). Essure was removed on (b)(6) 2015. In (b)(6) 2015, the pain, paraesthesia, hypoaesthesia, dysgeusia and migraine had resolved. By the time of death, the pelvic pain, device breakage, allergy to metals, nausea, anxiety, injury, metal poisoning, malaise and arthralgia outcome was unknown. The patient died on (b)(6) 2015 and the reported cause of death was pulmonary thromboembolism, intracardiac thrombus, eosinophilia and cardiac arrest. The reporter considered allergy to metals, anxiety, arthralgia, cardiac arrest, device breakage, dysgeusia, eosinophilia, hypoaesthesia, injury, intracardiac thrombus, malaise, metal poisoning, migraine, nausea, pain, paraesthesia, pelvic pain and pulmonary embolism to be related to essure. The reporter commented: ondansetron and diclofenac were used in 2014 but were not very effective and she was taken off of them. A week after essure removal, the patient stated that she had not felt that well in years and appeared to make an improvement/after essure removal, mental anguish and suffering associated with her physical injuries improved. On (b)(6) 2015, she came home after a long day of driving and complained of not feeling well and went to bed. She was found in her bed at approximately 11:00 a. M. The autopsy revealed the cause of death to be "pulmonary thromboembolism due to right cardiac thrombosis due to peripheral eosinophilia" to her hysterectomy surgery to remove the essure device. Number of coils: left: 3; right: 3. Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 34. 7 kg/sqm. Dehydroepiandrosterone test - on an unknown date: negative. Pregnancy test - on an unknown date: negative. Ultrasound pelvis - on an unknown date: normal. X-ray - on an unknown date: results: essure device was broken. Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records : migraines, pelvic pain, joint pain, pain, dysgeusia and dyspnoea. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 14-jan-2019: update of information (batch is not valid). Incident: a (b)(6) year-old female patient received insertion of essure fallopian tube occlusion insert for contraception. Approx. 2. 5 years after insertion, she began to suffer from severe, radiating pelvic pain and numerous other events, including nickel allergy and device breakage. Analgesics remained ineffective therefore essure was removed by hysterectomy after approx. 4 years of use. Some events rapidly regressed, but 2 weeks post surgery, immediately after a long drive, the patient developed a fatal pulmonary embolism associated with intracardiac thrombosis, peripheral eosinophilia and cardiac arrest. Pain events, device breakage, and nickel allergy are anticipated events according to the reference safety information of essure, whereas the fatal events are unanticipated. Pain, device breakage, and allergy are part of the known safety profile of essure, therefore in this particular case a causality of essure for these events cannot be excluded (related). Regarding the thromboembolism and the associated complications, the patient had multiple independent risk factors of obesity, recent surgical intervention, and very recent long-haul traveling. However, since the surgery had become necessary to remove essure, and considering that the peripheral eosinophilia (mentioned in the causality chain of the thromboembolism) may have been caused or aggravated by the nickel allergy, a causal or contributory role of essure in these conditions cannot be excluded (related). No valid lot number or device sample was received in this case. We conducted a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

 
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Brand NameESSURE
Type of DeviceTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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
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,HEALTH PROFESS
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
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? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberESS305
Device LOT NumberDJ11115-NOT VALID
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/14/2019
Was Device Evaluated By Manufacturer? No
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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