| Model Number ESS305 |
| Device Problems
Loose or Intermittent Connection (1371); Sticking (1597)
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| Patient Problems
Abdominal Pain (1685); Menstrual Irregularities (1959); Pain (1994); Perforation (2001); Discomfort (2330)
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| Event Date 05/16/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure coils had come loose and perforated her fallopian tubes one coil had adhered to her bowel/ no essure device in her right tube") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced abdominal discomfort ("poking sensation in lower abdomen").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required), uterine spasm ("uterus was contracting during hsg"), pelvic pain ("severe stabbing pain in her pelvis- especially when bending over"), dyspareunia ("pain during intercourse") and dysmenorrhoea ("pain during her menstrual cycle").The patient was treated with surgery (underwent a laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, pelvic pain, dyspareunia and dysmenorrhoea was resolving, the abdominal discomfort outcome was unknown and the uterine spasm had resolved.The reporter considered dysmenorrhoea, dyspareunia, fallopian tube perforation and pelvic pain to be related to essure.The reporter provided no causality assessment for abdominal discomfort and uterine spasm with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index (b)(6).Most recent follow-up information incorporated above includes: on 1-aug-2017: summons received-case classification changed to potential legal and incident.New events added: severe stabbing pain in her pelvis --especially when bending over, pain during intercourse, pain during her menstrual cycle and essure coils had come loose and perforated her fallopian tubes; one coil had adhered to her bowel." 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure coils had come loose and perforated her fallopian tubes one coil had adhered to her bowel/ no essure device in her right tube/ perforation (fallopian tube)/") and device dislocation ("malposition of essure device / migration of essure device- sticking through right fallopian tube at the proximal aspect, near the ampullary portion/essure coil protruding from the left fallopian tube at the distal portion and this had personalized/") in a (b)(6) year-old female patient who had essure (batch no.676716) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "thermochoice em ablation concomitantly with essure implantation" on (b)(6) 2009 and device difficult to use "tube was malformed or shaped differently, so the coils couldn't go in all the way".The patient's past medical history included multigravida, parity 2 ((b)(6) 2002 and (b)(6) 2004), spontaneous abortion ((b)(6) 2000 and (b)(6) 2001) in 2000, ectopic pregnancy, hypertension, urticaria, fatigue, insomnia, anxiety, depression, fatigue, insomnia, anxiety, depression, c-section (2004,2002), d & c, adhesiolysis, pap smear abnormal in 1998, ectopic pregnancy, chickenpox and adhesiolysis in 2013.Previously administered products included for an unreported indication: aleve, iud and flagyl.Past adverse reactions to the above products included urticaria with flagyl and aleve.Concurrent conditions included obesity, depression, high cholesterol, fatty liver, menorrhagia, menorrhagia, antinuclear antibody positive, itch, penicillin allergy (hives), anger and alcoholic.Family history included rhinitis (mother,father,siblings,children), diabetes (mother), hypertension (mother, father), high cholesterol (mother,father), smoker (mother,paternal grandmother) and depression (father,paternal grandmother).Concomitant products included aciclovir (acyclovir [aciclovir]) since (b)(6) 2015, atorvastatin since (b)(6) 2015, cetirizine since (b)(6) 2011, citalopram since 2007, desvenlafaxine succinate (pristiq) from (b)(6) 2010 to (b)(6) 2011, famotidine (pepcid) since (b)(6) 2011, montelukast (singulair) since (b)(6) 2011 and tocopherol (vitamin e) since 2015.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced abdominal discomfort ("poking sensation in lower abdomen").On (b)(6) 2010, the patient experienced dyspareunia ("pain during intercourse (painful sexual intercourse)").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("pain during her menstrual cycle").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, uterine spasm ("uterus was contracting during hsg"), intestinal adhesion lysis ("adhesion to bowel to left fallopian tube/ surgery to take down of omentum from the anterior abdominal wall and take down of adhesion of the large bowel from the left fallopian tube"), abdominal distension ("unsatisfactory distension"), medical device discomfort ("essure coils are uncomfortable and she wants them taken out") and libido disorder ("change in sex drive").The patient was treated with surgery (underwent a laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, uterine spasm, dyspareunia and libido disorder had resolved, the device dislocation, abdominal discomfort, intestinal adhesion lysis, abdominal distension and medical device discomfort outcome was unknown and the dysmenorrhoea was resolving.The reporter provided no causality assessment for abdominal discomfort and uterine spasm with essure.The reporter considered abdominal distension, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, intestinal adhesion lysis, libido disorder and medical device discomfort to be related to essure.The reporter commented: left essure device was attaching itself to the colon.Tube was malformed or shaped differently, she does require removal of any all normal appearing ovary, removal d uterus and cervix.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tubes.Late 2011 or early 2012 - ultrasound showed that there was one essure device in her left tube and no essure device in her right tube.Patient had ultrasound resulted in the uterus is 7.3 by 4.5 by 4.2.Anteverted.Endometrial stripe thickness was 2.65 mm.Ill-defined.No obvious mass or collection of fluid in the endometrium.Both ovaries are seen.The left measures 3.2 by 2.1 by 1.1.The right 2.9 by 1.9.The right coif is visualized, the left coil can not be confirmed.On (b)(6) 2006 patient had left breast examination resulted in category 2 * benign finding.On (b)(6) 2008 patient had exam resulted in breast has fibrocystic changes.No dominant masses the cervix multiparous without lesions.The iud string is approximately 2 cm and in the proper position.On (b)(6) 2009 patient had lumbosacral spine ap, lateral with oblique views, four view resulted in grade i spondylolisthesis l5-s1 probably due to bilateral l5 spondylolysis.On (b)(6) 2010 patient had liver ultrasound resulted in diffuse fatty infiltration of the liver.On (b)(6) 2010 patient had gynecological exam resulted in the right coil of essure device is placed along the right side of the uterus.The left coil can not be confirmed with 2d or 3d imaging.On (b)(6) 2013 patient had xr abdomen kub resulted in single view of the abdomen demonstrates a moderate amount of stool throughout the colon.Essure devices are seen in the pelvis.There are no osseous abnormalities.On (b)(6) 2013 patient had surgical pathology report resulted in uterus, cervix, bilateral tubes - received is a pear-shaped uterus with attached cervix and bilateral adnexa.The adnexa are removed and the uterus and cervix together measure 9.8 x 5.5 x 4.5 cm and weigh 84.2 gm.The ectocervix is purple to tan, smooth, and glistening.Sections through the cervix reveal gelatinous filled cystic structures.Themyometrium is pink to light tan and trabeculae and coiled wire over thread contraceptive device is oted within the endometrial cavity extending into the right cornual space, but grossly not entering the fallopian tube.The endometrial cavity is scarred and irregular with the lower portion extremely stenotic.Portions of tan endometrium are noted within the right cornual space measuring 0.3 cm in thickness.No other mas1les or lesions are noted within the myometrium_ the fallopian tubes are both purple to tan, each with attached fimbriated ends, and each measures approximately 7 cm in length and 0.5 cm in diameter.Sections through the left tube reveal a gray metallic wire wound over thread contraceptive device noted within the lumen.The fallopian tube lumens are otherwise grossly unremarkable.Rs, a 1through ab.A 1 - cervix.A2 - full thickness anterior wall of uterus.A3 - fun thickness posterior wall ofuterus.A4 ¿ additional portions of serosa from uterine base.As - right fallopian tube.A6 -left fallopian tube concerning the injuries reported in this case, the following one/ones were reported via medical record:- medical device monitoring error most recent follow-up information incorporated above includes: on 5-feb-2018: reporter added, lot number received, historical condition added, concomitant condition added,lab data added, events added as follows:- device dislocation, abdominal adhesions, abdominal pain lower, device difficult to use, abdominal distension, medical device discomfort, medical device monitoring error, sexual dysfunction.Incident: at the time of reporting, 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure coils had come loose and perforated her fallopian tubes one coil had adhered to her bowel/ no essure device in her right tube/ perforation (fallopian tube)/"), intestinal adhesion lysis ("adhesion to bowel to left fallopian tube/ surgery to take down of omentum from the anterior abdominal wall and take down of adhesion of the large bowel from the left fallopian tube") and device dislocation ("malposition of essure device / migration of essure device- sticking through right fallopian tube at the proximal aspect, near the ampullary portion/essure coil protruding from the left fallopian tube at the distal portion and this had personalized/") in a (b)(6) year-old female patient who had essure (batch no.676716) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "thermochoice em ablation concomitantly with essure implantation" on (b)(6) 2009 and device difficult to use "tube was malformed or shaped differently, so the coils couldn't go in all the way".The patient's past medical history included multigravida, parity 2 ((b)(6) 2002 and (b)(6) 2004), spontaneous abortion ((b)(6) 2000 and (b)(6) 2001) in 2000, ectopic pregnancy, hypertension, urticaria, fatigue, insomnia, anxiety, depression, fatigue, insomnia, anxiety, depression, c-section (2004,2002), d & c, adhesiolysis, pap smear abnormal in 1998, ectopic pregnancy, chickenpox and adhesiolysis in 2013.Previously administered products included for an unreported indication: aleve, iud and flagyl.Past adverse reactions to the above products included urticaria with flagyl and aleve.Concurrent conditions included obesity, depression, high cholesterol, fatty liver, menorrhagia, menorrhagia, antinuclear antibody positive, itch, penicillin allergy (hives), anger and alcoholic.Family history included rhinitis (mother,father,siblings,children), diabetes (mother), hypertension (mother, father), high cholesterol (mother,father), smoker (mother,paternal grandmother) and depression (father,paternal grandmother).Concomitant products included aciclovir (acyclovir [aciclovir]) since (b)(6) 2015, atorvastatin since (b)(6) 2015, cetirizine since (b)(6) 2011, citalopram since 2007, desvenlafaxine succinate (pristiq) from (b)(6) 2010 to (b)(6) 2011, famotidine (pepcid) since (b)(6) 2011, montelukast (singulair) since (b)(6) 2011 and tocopherol (vitamin e) since 2015.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced abdominal discomfort ("poking sensation in lower abdomen").On (b)(6) 2010, the patient experienced dyspareunia ("pain during intercourse (painful sexual intercourse)").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("pain during her menstrual cycle").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, uterine spasm ("uterus was contracting during hsg"), intestinal adhesion lysis (seriousness criteria medically significant and intervention required), abdominal distension ("unsatisfactory distension"), medical device discomfort ("essure coils are uncomfortable and she wants them taken out") and libido disorder ("change in sex drive").The patient was treated with surgery (underwent a laparoscopic hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, uterine spasm, dyspareunia and libido disorder had resolved, the device dislocation, abdominal discomfort, intestinal adhesion lysis, abdominal distension and medical device discomfort outcome was unknown and the dysmenorrhoea was resolving.The reporter provided no causality assessment for abdominal discomfort and uterine spasm with essure.The reporter considered abdominal distension, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, intestinal adhesion lysis, libido disorder and medical device discomfort to be related to essure.The reporter commented: left essure device was attaching itself to the colon.Tube was malformed or shaped differently, she does require removal of any all normal appearing ovary, removal d uterus and cervix.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tubes.Late 2011 or early 2012 - ultrasound showed that there was one essure device in her left tube and no essure device in her right tube.Patient had ultrasound resulted in the uterus is 7.3 by 4.5 by 4.2.Anteverted.Endometrial stripe thickness was 2.65 mm.Ill-defined.No obvious mass or collection of fluid in the endometrium.Both ovaries are seen.The left measures 3.2 by 2.1 by 1.1.The right 2.9 by 1.9.The right coif is visualized, the left coil can not be confirmed.On (b)(6) 2006 patient had left breast examination resulted in category 2 * benign finding.On (b)(6) 2008 patient had exam resulted in breast has fibrocystic changes.No dominant masses the cervix multiparous without lesions.The iud string is approximately 2 cm and in the proper position.On (b)(6) 2009 patient had lumbosacral spine ap, lateral with oblique views, four view resulted in grade i spondylolisthesis l5-s1 probably due to bilateral l5 spondylolysis.On (b)(6) 2010 patient had liver ultrasound resulted in diffuse fatty infiltration of the liver.On (b)(6) 2010 patient had gynecological exam resulted in the right coil of essure device is placed along the right side of the uterus.The left coil can not be confirmed with 2d or 3d imaging.On (b)(6) 2013 patient had xr abdomen kub resulted in single view of the abdomen demonstrates a moderate amount of stool throughout the colon.Essure devices are seen in the pelvis.There are no osseous abnormalities.On (b)(6) 2013 patient had surgical pathology report resulted in uterus, cervix, bilateral tubes - received is a pear-shaped uterus with attached cervix and bilateral adnexa.The adnexa are removed and the uterus and cervix together measure 9.8 x 5.5 x 4.5 cm and weigh 84.2 gm.The ectocervix is purple to tan, smooth, and glistening.Sections through the cervix reveal gelatinous filled cystic structures.Themyometrium is pink to light tan and trabeculae and coiled wire over thread contraceptive device is oted within the endometrial cavity extending into the right cornual space, but grossly not entering the fallopian tube.The endometrial cavity is scarred and irregular with the lower portion extremely stenotic.Portions of tan endometrium are noted within the right cornual space measuring 0.3 cm in thickness.No other mas1les or lesions are noted within the myometrium_ the fallopian tubes are both purple to tan, each with attached fimbriated ends, and each measures approximately 7 cm in length and 0.5 cm in diameter.Sections through the left tube reveal a gray metallic wire wound over thread contraceptive device noted within the lumen.The fallopian tube lumens are otherwise grossly unremarkable.Rs, a 1through ab.A 1 - cervix.A2 - full thickness anterior wall of uterus.A3 - fun thickness posterior wall ofuterus.A4 ¿ additional portions of serosa from uterine base.As - right fallopian tube.A6 -left fallopian tube concerning the injuries reported in this case, the following one/ones were reported via medical record:- medical device monitoring error most recent follow-up information incorporated above includes: on 5-feb-2018: reporter added, lot number received, historical condition added, concomitant condition added,lab data added, events added as follows:- device dislocation, abdominal adhesions, abdominal pain lower, device difficult to use, abdominal distension, medical device discomfort, medical device monitoring error, sexual dysfunction on 26-feb-2018: following company internal coding review, the previous reported event "adhesion to bowel to left fallopian tube/ surgery to take down of omentum from the anterior abdominal wall and take down of adhesion of the large bowel from the left fallopian tube" was recoded to the meddra llt: intestinal adhesion lysis.The event was upgraded to incident, narrative amended.Incident: at the time of reporting, 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure coils had come loose and perforated her fallopian tubes one coil had adhered to her bowel/ no essure device in her right tube/ perforation (fallopian tube)/"), device dislocation ("malposition of essure device / migration of essure device- sticking through right fallopian tube at the proximal aspect, near the ampullary portion/essure coil protruding from the left fallopian tube at the distal portion and this had personalized/") and intestinal adhesion lysis ("adhesion to bowel to left fallopian tube/ surgery to take down of omentum from the anterior abdominal wall and take down of adhesion of the large bowel from the left fallopian tube") in a 33-year-old female patient who had essure (batch no.676716) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "thermochoice em ablation concomitantly with essure implantation" on (b)(6) 2009 and device difficult to use "tube was malformed or shaped differently, so the coils couldn't go in all the way".The patient's past medical history included multigravida, parity 2 ((b)(6) 2002 and (b)(6) 2004), spontaneous abortion ((b)(6) 2000 and (b)(6) 2001) in 2000, ectopic pregnancy, hypertension, urticaria, fatigue, insomnia, anxiety, depression, fatigue, insomnia, anxiety, depression, c-section (2004,2002), d & c, adhesiolysis, pap smear abnormal in 1998, ectopic pregnancy, chickenpox and adhesiolysis in 2013.Previously administered products included for an unreported indication: iud, flagyl and aleve.Past adverse reactions to the above products included urticaria with flagyl and aleve.Concurrent conditions included obesity, depression, high cholesterol, fatty liver, menorrhagia, menorrhagia, antinuclear antibody positive, itch, penicillin allergy (hives), anger and alcoholic.Family history included rhinitis (mother,father,siblings,children), diabetes (mother), hypertension (mother, father), high cholesterol (mother,father), smoker (mother,paternal grandmother) and depression (father,paternal grandmother).Concomitant products included aciclovir (acyclovir [aciclovir]) since (b)(6) 2015, atorvastatin since (b)(6) 2015, cetirizine since (b)(6) 2011, citalopram since 2007, desvenlafaxine succinate (pristiq) from 26-oct-2010 to 23-jul-2011, famotidine (pepcid) since (b)(6) 2011, montelukast (singulair) since (b)(6) 2011 and tocopherol (vitamin e) since 2015.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced abdominal discomfort ("poking sensation in lower abdomen").On (b)(6) 2010, the patient experienced dyspareunia ("pain during intercourse (painful sexual intercourse)").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("pain during her menstrual cycle").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, intestinal adhesion lysis (seriousness criteria medically significant and intervention required), uterine spasm ("uterus was contracting during hsg"), abdominal distension ("unsatisfactory distension"), medical device discomfort ("essure coils are uncomfortable and she wants them taken out") and libido disorder ("change in sex drive").The patient was treated with surgery (underwent a laparoscopic hysterectomy with bilateral salpingectomy), surgery (hysterectomy with bilateral salpingectomy) and surgery (adhesiolysis).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, uterine spasm, dyspareunia and libido disorder had resolved, the device dislocation, intestinal adhesion lysis, abdominal discomfort, abdominal distension and medical device discomfort outcome was unknown and the dysmenorrhoea was resolving.The reporter provided no causality assessment for abdominal discomfort and uterine spasm with essure.The reporter considered abdominal distension, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, intestinal adhesion lysis, libido disorder and medical device discomfort to be related to essure.The reporter commented: left essure device was attaching itself to the colon.Tube was malformed or shaped differently, she does require removal of any all normal appearing ovary, removal d uterus and cervix.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tubes.Late 2011 or early 2012.Ultrasound showed that there was one essure device in her left tube and no essure device in her right tube.Patient had ultrasound resulted in the uterus is 7.3 by 4.5 by 4.2.Anteverted.Endometrial stripe thickness was 2.65 mm.Ill-defined.No obvious mass or collection of fluid in the endometrium.Both ovaries are seen.The left measures 3.2 by 2.1 by 1.1.The right 2.9 by 1.9.The right coif is visualized, the left coil can not be confirmed.On (b)(6) 2006 patient had left breast examination resulted in category 2 benign finding.On (b)(6) 2008 patient had exam resulted in breast has fibrocystic changes.No dominant masses the cervix multiparous without lesions.The iud string is approximately 2 cm and in the proper position.On (b)(6) 2009 patient had lumbosacral spine ap, lateral with oblique views, four view resulted in grade i spondylolisthesis l5-s1 probably due to bilateral l5 spondylolysis.On (b)(6) 2010 patient had liver ultrasound resulted in diffuse fatty infiltration of the liver.On (b)(6) 2010 patient had gynecological exam resulted in the right coil of essure device is placed along the right side of the uterus.The left coil can not be confirmed with 2d or 3d imaging.On (b)(6) 2013 patient had xr abdomen kub resulted in single view of the abdomen demonstrates a moderate amount of stool throughout the colon.Essure devices are seen in the pelvis.There are no osseous abnormalities.On (b)(6) 2013 patient had surgical pathology report resulted in uterus, cervix, bilateral tubes.Received is a pear-shaped uterus with attached cervix and bilateral adnexa.The adnexa are removed and the uterus and cervix together measure 9.8 x 5.5 x 4.5 cm and weigh 84.2 gm.The ectocervix is purple to tan, smooth, and glistening.Sections through the cervix reveal gelatinous filled cystic structures.The myometrium is pink to light tan and trabeculae and coiled wire over thread contraceptive device is noted within the endometrial cavity extending into the right cornual space, but grossly not entering the fallopian tube.The endometrial cavity is scarred and irregular with the lower portion extremely stenotic.Portions of tan endometrium are noted within the right cornual space measuring 0.3 cm in thickness.No other mas1le's or lesions are noted within the myometrium_ the fallopian tubes are both purple to tan, each with attached fimbriated ends, and each measures approximately 7 cm in length and 0.5 cm in diameter.Sections through the left tube reveal a gray metallic wire wound over thread contraceptive device noted within the lumen.The fallopian tube lumens are otherwise grossly unremarkable.Rs, a1 through ab.A1 - cervix.A2 - full thickness anterior wall of uterus.A3 - fun thickness posterior wall of uterus.A4 ¿ additional portions of serosa from uterine base.As - right fallopian tube.A6 -left fallopian tube.Concerning the injuries reported in this case, the following one/ones were reported via medical record:- medical device monitoring error.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of product technical complaint.Incident.At the time of reporting, 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("essure coils had come loose and perforated her fallopian tubes one coil had adhered to her bowel/ no essure device in her right tube/"), device dislocation ("malposition of essure device / migration of essure device- sticking through right fallopian tube at the proximal aspect, near the ampullary portion/essure coil protruding from the left fallopian tube at the distal portion and this had personalized/") and intestinal adhesion lysis ("adhesion to bowel to left fallopian tube/ surgery to take down of omentum from the anterior abdominal wall and take down of adhesion of the large bowel from the left fallopian tube") in a 33-year-old female patient who had essure (batch no.676716) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "thermochoice em ablation concomitantly with essure implantation" on (b)(6) 2009 and device difficult to use "tube was malformed or shaped differently, so the coils couldn't go in all the way".The patient's past medical history included multigravida, parity 2 ((b)(6) 2002 and (b)(6) 2004), spontaneous abortion ((b)(6) 2000 and (b)(6) 2001) in 2000, ectopic pregnancy, hypertension, urticaria, fatigue, insomnia, anxiety, postpartum depression, fatigue, insomnia, anxiety, depression, c-section (2004,2002), d & c, adhesiolysis, pap smear abnormal in 1998, ectopic pregnancy, chickenpox and adhesiolysis in 2013.Previously administered products included for an unreported indication: aleve, iud and flagyl.Past adverse reactions to the above products included urticaria with flagyl and aleve.Concurrent conditions included obesity, depression, high cholesterol, fatty liver, menorrhagia, menorrhagia, antinuclear antibody positive, itch, penicillin allergy (hives), anger and alcoholic.Family history included rhinitis (mother,father,siblings,children), diabetes (mother), hypertension (mother, father), high cholesterol (mother,father), smoker (mother,paternal grandmother) and depression (father,paternal grandmother).Concomitant products included tocopherol (vitamin e) since 2015 for fatty liver, atorvastatin since (b)(6) 2015 for high cholesterol, montelukast (singulair) since (b)(6) 2011 for hives, citalopram since 2007 for postpartum depression as well as aciclovir (acyclovir [aciclovir]) since (b)(6) 2015, cetirizine since (b)(6) 2011, desvenlafaxine succinate (pristiq) from 26-oct-2010 to 27-feb-2011 and famotidine (pepcid) since (b)(6) 2011.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced abdominal discomfort ("poking sensation in lower abdomen").On (b)(6) 2010, the patient experienced dyspareunia ("pain during intercourse (painful sexual intercourse)").On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, device dislocation (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("pain during her menstrual cycle").On an unknown date, the patient underwent intestinal adhesion lysis (seriousness criteria medically significant and intervention required), uterine spasm ("uterus was contracting during hsg"), abdominal distension ("unsatisfactory distension"), medical device discomfort ("essure coils are uncomfortable and she wants them taken out"), libido disorder ("change in sex drive") and inadequate lubrication ("lack of adequate lubrification").The patient was treated with surgery (underwent a laparoscopic hysterectomy with bilateral salpingectomy.), surgery (hysterectomy with bilateral salpingectomy) and surgery (adhesiolysis).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, uterine spasm, dyspareunia, libido disorder and inadequate lubrication had resolved, the device dislocation, intestinal adhesion lysis, abdominal discomfort, abdominal distension and medical device discomfort outcome was unknown and the dysmenorrhoea was resolving.The reporter provided no causality assessment for abdominal discomfort and uterine spasm with essure.The reporter considered abdominal distension, device dislocation, dysmenorrhoea, dyspareunia, fallopian tube perforation, inadequate lubrication, intestinal adhesion lysis, libido disorder and medical device discomfort to be related to essure.The reporter commented: *left essure device was attaching itself to the colon.Tube was malformed or shaped differently, she does require removal of any all normal appearing ovary, removal d uterus and cervix.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on (b)(6) 2010: confirming full occlusion of fallopian tubes.Late 2011 or early 2012.Ultrasound showed that there was one essure device in her left tube and no essure device in her right tube.Patient had ultrasound resulted in the uterus is 7.3 by 4.5 by 4.2.Anteverted.Endometrial stripe thickness was 2.65 mm.Ill-defined.No obvious mass or collection of fluid in the endometrium.Both ovaries are seen.The left measures 3.2 by 2.1 by 1.1.The right 2.9 by 1.9.The right coif is visualized, the left coil can not be confirmed.On (b)(6) 2006 patient had left breast examination resulted in category 2 * benign finding.On (b)(6) 2008 patient had exam resulted in breast has fibrocystic changes.No dominant masses the cervix multiparous without lesions.The iud string is approximately 2 cm and in the proper position.On (b)(6) 2009 patient had lumbosacral spine ap, lateral with oblique views, four view resulted in grade i spondylolisthesis l5-s1 probably due to bilateral l5 spondylolysis.On (b)(6) 2010 patient had liver ultrasound resulted in diffuse fatty infiltration of the liver.On (b)(6) 2010 patient had gynecological exam resulted in the right coil of essure device is placed along the right side of the uterus.The left coil can not be confirmed with 2d or 3d imaging.On (b)(6) 2013 patient had xr abdomen kub resulted in single view of the abdomen demonstrates a moderate amount of stool throughout the colon.Essure devices are seen in the pelvis.There are no osseous abnormalities.On (b)(6) 2013 patient had surgical pathology report resulted in uterus, cervix, bilateral tubes - received is a pear-shaped uterus with attached cervix and bilateral adnexa.The adnexa are removed and the uterus and cervix together measure 9.8 x 5.5 x 4.5 cm and weigh 84.2 gm.The ectocervix is purple to tan, smooth, and glistening.Sections through the cervix reveal gelatinous filled cystic structures.Themyometrium is pink to light tan and trabeculae and coiled wire over thread contraceptive device is oted within the endometrial cavity extending into the right cornual space, but grossly not entering the fallopian tube.The endometrial cavity is scarred and irregular with the lower portion extremely stenotic.Portions of tan endometrium are noted within the right cornual space measuring 0.3 cm in thickness.No other mas1les or lesions are noted within the myometrium_ the fallopian tubes are both purple to tan, each with attached fimbriated ends, and each measures approximately 7 cm in length and 0.5 cm in diameter.Sections through the left tube reveal a gray metallic wire wound over thread contraceptive device noted within the lumen.The fallopian tube lumens are otherwise grossly unremarkable.Rs, a 1through ab.A 1 - cervix.A2 - full thickness anterior wall of uterus.A3 - fun thickness posterior wall ofuterus.A4 ¿ additional portions of serosa from uterine base.As - right fallopian tube.A6 -left fallopian tube concerning the injuries reported in this case, the following one/ones were reported via medical record:- medical device monitoring error.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on 9-apr-2018: new event was added (lack of adequate lubrification).Plaintiff¿s medical history and concomitant medication were updated.Incident at the time of reporting, 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("e20ssure coils had come loose and perforated her fallopian tubes one coil had adhered to her bowel/ no essure device in her right tube/"), device dislocation ("malposition of essure device / migration of essure device- sticking through right fallopian tube at the proximal aspect, near the ampullary portion/essure coil protruding from the left fallopian tube at the distal portion and this had personalized/"), intestinal adhesion lysis ("adhesion to bowel to left fallopian tube/ surgery to take down of omentum from the anterior abdominal wall and take down of adhesion of the large bowel from the left fallopian tube") and haematochezia ("blood in stool") in a 33-year-old female patient who had essure (batch no.676716) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: medical device monitoring error "thermochoice em ablation concomitantly with essure implantation" on (b)(6) 2009 and device difficult to use "tube was malformed or shaped differently, so the coils couldn't go in all the way".The patient's past medical history included multigravida, parity 2 ((b)(6) 2002 and (b)(6) 2004), spontaneous abortion ((b)(6) 2000 and (b)(6) 2001) in 2000, ectopic pregnancy, hypertension, urticaria, fatigue, insomnia, anxiety, postpartum depression, fatigue, insomnia, anxiety, depression, c-section (2004,2002), d & c, adhesiolysis, pap smear abnormal in 1998, ectopic pregnancy, chickenpox and adhesiolysis in 2013.Previously administered products included for an unreported indication: iud, mirena, flagyl and aleve.Past adverse reactions to the above products included urticaria with flagyl and aleve.Concurrent conditions included obesity, depression, high cholesterol, fatty liver, menorrhagia, menorrhagia, antinuclear antibody positive, itch, penicillin allergy (hives), anger and alcoholic.Family history included rhinitis (mother,father,siblings,children), diabetes (mother), hypertension (mother, father), high cholesterol (mother,father), smoker (mother,paternal grandmother) and depression (father,paternal grandmother).Concomitant products included tocopherol (vitamin e) since 2015 for fatty liver, atorvastatin since (b)(6) 2015 for high cholesterol, montelukast (singulair) since (b)(6) 2011 for hives, citalopram since 2007 for postpartum depression as well as aciclovir (acyclovir [aciclovir]) since (b)(6) 2015, cetirizine since (b)(6) 2011, desvenlafaxine succinate (pristiq) from (b)(6) 2010 to (b)(6) 2011 and famotidine (pepcid) since (b)(6) -2011.On (b)(6) 2009, the patient had essure inserted.In 2010, the patient experienced abdominal discomfort ("poking sensation in lower abdomen").On (b)(6) 2010, the patient experienced dyspareunia ("pain during intercourse (painful sexual intercourse)").On (b)(6) 2013, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain lower, device dislocation (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("pain during her menstrual cycle").On an unknown date, the patient underwent intestinal adhesion lysis (seriousness criteria medically significant and intervention required), uterine spasm ("uterus was contracting during hsg"), abdominal distension ("unsatisfactory distension"), medical device discomfort ("essure coils are uncomfortable and she wants them taken out"), libido disorder ("change in sex drive"), inadequate lubrication ("lack of adequate lubrification"), infection ("infection"), menorrhagia ("bad periods"), scar ("scar tisue"), skin lesion ("lesion"), endometriosis ("endometriosis"), constipation ("constipation"), arthritis ("arthritis"), peripheral swelling ("swollen feet"), hormone level abnormal ("hormonal imbalance"), urticaria ("hives"), ovarian cyst ("ovarian cyst"), oropharyngeal pain ("sore throat"), hepatic enzyme abnormal ("elavated liver enzyme"), antinuclear antibody positive ("ana"), irritable bowel syndrome ("ibs"), gastrointestinal disorder ("colon leisons"), malaise ("i have sick little one"), adenomyosis ("adenomyosis in uterus"), back pain ("dull ache in lower back"), back disorder ("back problems"), haemorrhoids ("internal hemorrhoid") and haematochezia (seriousness criterion medically significant).The patient was treated with surgery (underwent a laparoscopic hysterectomy with bilateral salpingectomy) and surgery (adhesiolysis).Essure was removed on (b)(6) 2013.At the time of the report, the fallopian tube perforation, uterine spasm, dyspareunia, libido disorder, inadequate lubrication and back pain had resolved, the device dislocation, intestinal adhesion lysis, abdominal discomfort, abdominal distension, medical device discomfort, infection, menorrhagia, scar, skin lesion, endometriosis, constipation, arthritis, peripheral swelling, hormone level abnormal, urticaria, ovarian cyst, oropharyngeal pain, hepatic enzyme abnormal, antinuclear antibody positive, irritable bowel syndrome, gastrointestinal disorder, malaise, adenomyosis, back disorder, haemorrhoids and haematochezia outcome was unknown and the dysmenorrhoea was resolving.The reporter provided no causality assessment for abdominal discomfort and uterine spasm with essure.The reporter considered abdominal distension, adenomyosis, antinuclear antibody positive, arthritis, back disorder, back pain, constipation, device dislocation, dysmenorrhoea, dyspareunia, endometriosis, fallopian tube perforation, gastrointestinal disorder, haematochezia, haemorrhoids, hepatic enzyme abnormal, hormone level abnormal, inadequate lubrication, infection, intestinal adhesion lysis, irritable bowel syndrome, libido disorder, malaise, medical device discomfort, menorrhagia, oropharyngeal pain, ovarian cyst, peripheral swelling, scar, skin lesion and urticaria to be related to essure.The reporter commented: *left essure device was attaching itself to the colon.Tube was malformed or shaped differently, she does require removal of any all normal appearing ovary, removal d uterus and cervix.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.9 kg/sqm.Hysterosalpingogram - on(b)(6) 2010: confirming full occlusion of fallopian tubes.Late 2011 or early 2012 - ultrasound showed that there was one essure device in her left tube and no essure device in her right tube.Patient had ultrasound resulted in the uterus is 7.3 by 4.5 by 4.2.Anteverted.Endometrial stripe thickness was 2.65 mm.Ill-defined.No obvious mass or collection of fluid in the endometrium.Both ovaries are seen.The left measures 3.2 by 2.1 by 1.1.The right 2.9 by 1.9.The right coif is visualized, the left coil can not be confirmed.On (b)(6) 2006 patient had left breast examination resulted in category 2 * benign finding.On (b)(6) 2008 patient had exam resulted in breast has fibrocystic changes.No dominant masses the cervix multiparous without lesions.The iud string is approximately 2 cm and in the proper position.On (b)(6) 2009 patient had lumbosacral spine ap, lateral with oblique views, four view resulted in grade i spondylolisthesis l5-s1 probably due to bilateral l5 spondylolysis.On (b)(6) 2010 patient had liver ultrasound resulted in diffuse fatty infiltration of the liver.On (b)(6) 2010 patient had gynecological exam resulted in the right coil of essure device is placed along the right side of the uterus.The left coil can not be confirmed with 2d or 3d imaging.On (b)(6) 2013 patient had xr abdomen kub resulted in single view of the abdomen demonstrates a moderate amount of stool throughout the colon.Essure devices are seen in the pelvis.There are no osseous abnormalities.On (b)(6) 2013 patient had surgical pathology report resulted in uterus, cervix, bilateral tubes - received is a pear-shaped uterus with attached cervix and bilateral adnexa.The adnexa are removed and the uterus and cervix together measure 9.8 x 5.5 x 4.5 cm and weigh 84.2 gm.The ectocervix is purple to tan, smooth, and glistening.Sections through the cervix reveal gelatinous filled cystic structures.Themyometrium is pink to light tan and trabeculae and coiled wire over thread contraceptive device is oted within the endometrial cavity extending into the right cornual space, but grossly not entering the fallopian tube.The endometrial cavity is scarred and irregular with the lower portion extremely stenotic.Portions of tan endometrium are noted within the right cornual space measuring 0.3 cm in thickness.No other mas1les or lesions are noted within the myometrium_ the fallopian tubes are both purple to tan, each with attached fimbriated ends, and each measures approximately 7 cm in length and 0.5 cm in diameter.Sections through the left tube reveal a gray metallic wire wound over thread contraceptive device noted within the lumen.The fallopian tube lumens are otherwise grossly unremarkable.Rs, a 1through ab.A 1 - cervix.A2 - full thickness anterior wall of uterus.A3 - fun thickness posterior wall ofuterus.A4 ¿ additional portions of serosa from uterine base.As - right fallopian tube.A6 -left fallopian tube concerning the injuries reported in this case, the following one/ones were reported via medical record:- medical device monitoring error.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-jun-2018: social media information received, events added are as follows- infection, menorrhagia, scar tissue, skin lesions, endometrosis, constipations, arthritis, peripheral swelling, hormone level abnormal, urticaria, ovarian cyst, oropharyngeal pain, hepatic enzyme abnormal, antinuclear antibody positive, irritable bowel syndrome, colon lesions, i have sick little one, adenomyosis, dull ache in lower back, back problems, internal hemorrhoid, blood in stool.Historical drug added.Incident at the time of reporting, 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.
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Search Alerts/Recalls
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