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

Model Number ESS305

Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Menstrual Irregularities (1959); Uterine Perforation (2121); Anxiety (2328); Depression (2361)

Event Date 08/26/2009

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("device was poking what appeared through the myometrium") and device expulsion ("device was poking what appeared through the myometrium") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "occlusion of left tube only" in 2009.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, 4 months 12 days after insertion of essure, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain and device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced fatigue ("fatigue"), dysmenorrhoea ("dysmenorrhea"), menorrhagia ("menorrhagia"), anxiety ("anxious") and depression ("depressed").The patient was treated with surgery (pelviscopic excision of displaced right essure device and right tubal coagulation).Essure was removed on (b)(6) 2009.At the time of the report, the embedded device, device expulsion, fatigue, dysmenorrhoea, menorrhagia, anxiety and depression outcome was unknown.The reporter considered anxiety, depression, device expulsion, dysmenorrhoea, embedded device, fatigue and menorrhagia to be related to essure.The reporter commented: only displaced right essure was removed.Left essure was not removed.Now major surgery is required-to remove the left essure device for relief of the symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2009: occlusion of left tube only.Further company follow-up with the consumer, lawyer or lawyer is not possible.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

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ("device was poking what appeared through the myometrium underneath serosa adjacent to fallopian tube") in a 33-year-old female patient who had essure (batch no.629140) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "occlusion of left tube only" in 2009.The patient's medical history included oligohydramnios and vaginal delivery.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced fatigue ("fatigue"), dysmenorrhoea ("dysmenorrhea/dysmenorrhea (cramping)"), menorrhagia ("menorrhagia/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines"), headache ("headache"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), dyspareunia ("dyspareunia(painful sexual intercourse)") and abdominal pain lower ("lower abdominal pain"), 17 days after insertion of essure.On (b)(6) 2009, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain.On an unknown date, the patient experienced anxiety ("anxious") and depression ("depressed").The patient was treated with surgery (pelviscopic excision of displaced right essure device and right tubal coagulation).At the time of the report, the embedded device, fatigue, dysmenorrhoea, menorrhagia, anxiety, depression, vaginal haemorrhage, migraine, female sexual dysfunction and dyspareunia outcome was unknown and the abdominal pain lower was resolving.The reporter considered abdominal pain lower, anxiety, depression, dysmenorrhoea, dyspareunia, embedded device, fatigue, female sexual dysfunction, headache, menorrhagia, migraine and vaginal haemorrhage to be related to essure.The reporter commented: only displaced right essure was removed.Left essure was not removed.Now major surgery is required-to remove the left essure device for relief of the symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: occlusion of left tube only.Result: one implant was not in right fallopian tube.Pathology test - on (b)(6) 2009: gross description: the specimen labeled removed implant - essure right side is received fresh and consists of two white metallic fragments of hardware.The first is wirelike and measures 2.9 cm in length by less than 0.1 em in diameter and is curved on one end.It is focally blood-tinged.The second fragment measures approximately 2.0 em in greatest dimension and is curled like a spring.It is twisted around itself.No adherent soft tissue identified.No sections are taken.Ar/mls.Further company follow-up with the consumer, lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on 4-feb-2019: plaintiff fact sheet and medical record received.Event added: abnormal bleeding (vaginal), migraines, headaches, apareunia(inability to have sexual intercourse), dyspareunia(painful sexual intercourse), lower abdominal pain.Event outcome was updated for the event: lower abdominal pain.Lot no.Was added.Lab data was added.Historical conditions were added.Reporter information was added.Incident we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('device was poking what appeared through the myometrium underneath serosa adjacent to fallopian tube') in a 33-year-old female patient who had essure (batch no.629140) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "occlusion of left tube only" in 2009.The patient's medical history included oligohydramnios and gravida.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced fatigue ("fatigue"), dysmenorrhoea ("dysmenorrhea/dysmenorrhea (cramping)"), menorrhagia ("menorrhagia/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines"), headache ("headache"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), dyspareunia ("dyspareunia(painful sexual intercourse)") and abdominal pain lower ("lower abdominal pain"), 17 days after insertion of essure.On (b)(6) 2009, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain.On an unknown date, the patient experienced anxiety ("anxious") and depression ("depressed").The patient was treated with surgery (pelviscopic excision of displaced right essure device and right tubal coagulation).At the time of the report, the embedded device, fatigue, dysmenorrhoea, menorrhagia, anxiety, depression, vaginal haemorrhage, migraine, female sexual dysfunction and dyspareunia outcome was unknown and the abdominal pain lower was resolving.The reporter considered abdominal pain lower, anxiety, depression, dysmenorrhoea, dyspareunia, embedded device, fatigue, female sexual dysfunction, headache, menorrhagia, migraine and vaginal haemorrhage to be related to essure.The reporter commented: only displaced right essure was removed.Left essure was not removed.Now major surgery is required-to remove the left essure device for relief of the symptoms.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: results: occlusion of left tube only.Result: one implant was not in right fallopian tube.Pathology test - on (b)(6) 2009: gross description: the specimen labeled removed implant - essure right side is received fresh and consists of two white metallic fragments of hardware.The first is wirelike and measures 2.9 cm in length by less than 0.1 em in diameter and is curved on one end.It is focally blood-tinged.The second fragment measures approximately 2.0 em in greatest dimension and is curled like a spring.It is twisted around itself.No adherent soft tissue identified.No sections are taken.Ar/mls.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on 23-may-2019: quality-safety evaluation of product technical compliant.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ('perforation: fallopian tubes / migration') and embedded device ('device was poking what appeared through the myometrium underneath serosa adjacent to fallopian tube ') in a 33-year-old female patient who had essure (batch no.629140) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "occlusion of left tube only" in 2009.The patient's medical history included oligohydramnios and gravida.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced fatigue ("fatigue"), dysmenorrhoea ("dysmenorrhea/dysmenorrhea (cramping)"), menorrhagia ("menorrhagia/abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), migraine ("migraines"), headache ("headache"), female sexual dysfunction ("apareunia(inability to have sexual intercourse)"), dyspareunia ("dyspareunia(painful sexual intercourse)") and abdominal pain lower ("lower abdominal pain"), 17 days after insertion of essure.On (b)(6) 2009, the patient experienced embedded device (seriousness criteria medically significant and intervention required) with pelvic pain.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), anxiety ("anxious / psych injury"), depression ("depressed / psych injury"), abdominal pain ("abdominal pain"), back pain ("back pain"), blood disorder ("blood/heart disorder"), cardiac disorder ("blood/heart disorder"), hypersensitivity ("allergy: other"), urinary tract disorder ("bladder/urinary problems: urinary probs") and urinary tract infection ("uti") and was found to have weight increased ("weight gain").The patient was treated with surgery (pelviscopic excision of displaced right essure device and right tubal coagulation).At the time of the report, the fallopian tube perforation, embedded device, dysmenorrhoea, menorrhagia, anxiety, depression, vaginal haemorrhage, female sexual dysfunction, dyspareunia, abdominal pain, back pain, blood disorder, cardiac disorder, hypersensitivity, urinary tract disorder and urinary tract infection outcome was unknown, the fatigue, migraine, headache and weight increased had resolved and the abdominal pain lower was resolving.The reporter considered abdominal pain, abdominal pain lower, anxiety, back pain, blood disorder, cardiac disorder, depression, dysmenorrhoea, dyspareunia, embedded device, fallopian tube perforation, fatigue, female sexual dysfunction, headache, hypersensitivity, menorrhagia, migraine, urinary tract disorder, urinary tract infection, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: only displaced right essure was removed.Left essure was not removed.Now major surgery is required-to remove the left essure device for relief of the symptoms.Patient received treatment for menorrhagia (heavy menstrual bleeding), blood/heart disorder, migration, perforation: fallopian tubes, urinary probs., uti, fatigue, migraines, headaches, weight gain.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2009: left occlusion only; on (b)(6) 2009: results: occlusion of left tube only.Result: one implant was not in right fallopian tube.Pathology test - on (b)(6) 2009: gross description: the specimen labeled removed implant - essure right side is received fresh and consists of two white metallic fragments of hardware.The first is wirelike and measures 2.9 cm in length by less than 0.1 em in diameter and is curved on one end.It is focally blood-tinged.The second fragment measures approximately 2.0 em in greatest dimension and is curled like a spring.It is twisted around itself.No adherent soft tissue identified.No sections are taken.Ar/mls.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received events "abdominal pain, back pain, blood/heart disorder, allergy: other, perforation: fallopian tubes, urinary probs., uti, weight gain" were added.Outcome of events "other" was updated as recovered.Lab data was added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7392686
• MDR Text Key: 104201839
• Report Number: 2951250-2018-01430
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2012
• Device Model Number: ESS305
• Device Lot Number: 629140
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 02/04/2019; 05/23/2019; 09/11/2019
• Supplement Dates FDA Received: 02/06/2019; 05/31/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR