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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Diarrhea (1811); Fatigue (1849); Nausea (1970); Internal Organ Perforation (1987); Pain (1994); Uterine Perforation (2121); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Weight Changes (2607); Foreign Body In Patient (2687); No Code Available (3191); Constipation (3274)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube(s))") and embedded device ("migration of essure device location of device: embedded in colon") in a (b)(6) 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 tonsillectomy.Previously administered products included for contraception: oral contraceptive nos from 2005 to (b)(6) 2018.Concurrent conditions included drug hypersensitivity.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, embedded device (seriousness criteria medically significant and intervention required), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), fatigue ("fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), constipation ("constipation"), diarrhoea ("diarrhea"), irritable bowel syndrome ("irritable bowel disorder (ibs)"), abdominal pain ("abdominal pain"), alopecia ("hair loss"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression"), stress ("stress"), weight increased ("weight gain"), pain in extremity ("leg pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (laparoscopic removal from my colon).Essure was removed in august 2017.At the time of the report, the fallopian tube perforation, embedded device, bladder disorder, fatigue, alopecia, migraine, headache, pain in extremity and vulvovaginal pain outcome was unknown, the urinary tract disorder, abdominal distension, constipation, diarrhoea, irritable bowel syndrome, abdominal pain, anxiety, depression and stress had not resolved and the nausea and weight increased was resolving.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, bladder disorder, constipation, depression, diarrhoea, embedded device, fallopian tube perforation, fatigue, headache, irritable bowel syndrome, nausea, pain in extremity, stress, urinary tract disorder, vulvovaginal pain and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: current weight: (b)(6).Approximate weight at the time of essure placement: 125 - 130 lbs.Diagnostic results: (b)(6) 2016 : hysterosalpingogram : bilateral fallopian tube potency, no association of identified essure coil to the uterus or fallopian tubes/the doctor stated that the coils were not in my tubes.On (b)(6) 2017: ct abdomen pelvis with contrast : perforated essure coil.Most recent follow-up information incorporated above includes: on (b)(6) 2018: events- "bladder problems or changes, urinary problems or changes, fatigue, gastrointestinal or digestive system condition type: bloating, constipation, diarrhea, irritable bowel disorder (ibs), abdominal pain, hair loss, migraines, headaches, migration of essure device location of device: embedded in colon, nausea, perforation (fallopian tube(s)), psychological or psychiatric problems condition: anxiety, psychological or psychiatric problems condition: depression, stress, weight gain, leg pain, vaginal pain", reporter, concomitant and historical condition added from pfs.On (b)(6) 2018: reporter added from medical record.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 fallopian tube perforation ("perforation (fallopian tube(s))") and device dislocation ("migration of essure device location of device: embedded in colon") in a 32-year-old female patient who had essure (batch no.731807) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included tonsillectomy, urodynamics measurement and prostate surgery.(b)(6) 2013: mri of the lumbar spine - findings: no compression fracture, spondylolisthesis or marrow replacement process.No visualized intrathecal, para-spinal or retroperitoneal mass.Previously administered products included for contraception: oral contraceptive nos from 2005 to (b)(6) 2019.Concurrent conditions included drug allergy, panic disorder, ovarian cyst, menses irregular, fibroids, vomiting, rib pain, cystitis, vaginal bleeding, dysmenorrhea, vaginal discharge abnormality, abdominal cramps, incontinence, menorrhagia, low back pain, trauma, anemia, arthritis, neuromuscular pain, dyspareunia, urinary incontinence aggravated, memory impaired, herniated disc, light headedness, chronic tonsillitis, sinusitis, ear ringing, swallowing difficult, slurred speech, emphysema, diabetes mellitus, gerd, glaucoma, gout, heart disease, unspecified, heart murmur, hepatitis c, hypertension, myocardial infarction, rash, upper respiratory infection, rheumatoid arthritis, seizures, sleep apnea, stroke, substance abuse, thyroid disorder, urinary tract infection, enteroenterostomy, sciatica, constipation, diarrhea, lumbar spondylosis, blurry vision, intestinal operation, tubal ligation (failed), dysuria and colitis.Concomitant products included amitriptyline, azithromycin (zithromax), clindamycin, codeine, ethinylestradiol;ferrous fumarate;norethisterone (femcon fe), hydrocodone, hydromorphone, ibuprofen, lorazepam, mirabegron (myrbetriq), oral contraceptive nos, oxybutynin, paracetamol (acetaminophen), simvastatin, topiramate, venlafaxine and vitamin d nos (vitamin d).In 2010, the patient experienced bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), nausea ("nausea"), pain in extremity ("leg pain") and vulvovaginal pain ("vaginal pain") and was found to have weight increased ("weight gain").On (b)(6) 2010, the patient had essure inserted.In 2013, the patient experienced alopecia ("hair loss").In 2014, the patient experienced anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression") and stress ("stress").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), constipation ("constipation"), diarrhoea ("diarrhea"), irritable bowel syndrome ("irritable bowel disorder (ibs)"), abdominal pain ("abdominal pain"), migraine ("migraines"), headache ("headaches/ back of my head pain") and complication of device insertion ("complications or problems that occurred at the time of your essure placement procedure: yes").The patient was treated with surgery (laparoscopic removal from my colon).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, device dislocation, bladder disorder, fatigue, migraine, headache, pain in extremity, vulvovaginal pain and complication of device insertion outcome was unknown, the urinary tract disorder, abdominal distension, constipation, diarrhoea, irritable bowel syndrome, abdominal pain, anxiety, depression and stress had not resolved and the alopecia, nausea and weight increased was resolving.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, bladder disorder, complication of device insertion, constipation, depression, device dislocation, diarrhoea, fallopian tube perforation, fatigue, headache, irritable bowel syndrome, migraine, nausea, pain in extremity, stress, urinary tract disorder, vulvovaginal pain and weight increased to be related to essure.The reporter commented: current weight: 153 lbs.Approximate weight at the time of essure placement: 125 - 130 lbs.Discrepancy noted in removal details: (b)(6) 2017, (b)(6) 2017.Diagnostic results (normal ranges are provided in parenthesis if available): chest x-ray - on (b)(6) 2013: impression: no acute pulmonary abnormality.No evidence of rib fracture.Computerised tomogram abdomen - on (b)(6) 2017: impression: contracted versus collapse of the descending colon and sigmoid colon.Questionable wall thickening of the distal descending colon.Colitis is not excluded.There is no adjacent pericolonic stranding and no free fluid.3mm non-obstructing right renal stone, mild hepatomegaly versus riedel's lobe of the liver.Computerised tomogram head - on (b)(6) 2015: impression: no acute intracranial hemorrhage or mass effect.Computerised tomogram pelvis - on (b)(6) 2013: impression: 3.5 centimeter right ovarian cyst with trace free pelvic fluid, the remainder of the exam is normal.Computerised tomogram spine - on (b)(6) 2015: result: the cervical spine is in anatomic alignment.The odontoid process and lateral masses are intact.There are no acute fractures or traumatic list thesis.No loss of vertebral height or disc space narrowing.There is no narrowing of the spinal canal.No prevertebral soft tissue swelling.The neural foramina are patent.Hysterosalpingogram - on (b)(6) 2016: bilateral fallopian tube potency, no association of identified essure coil to the uterus or fallopian tubes / the doctor stated that the coils were not in my tubes.; on (b)(6) 2016: results: bilateral fallopian tube potency.Coils were not in my tubes.Findings: the scout radiograph reveals a right-sided essure coil projecting over the right iliac wing.The pelvis is otherwise unremarkable.The uterus is grossly normal.Contrast fills both fallopian tubes normally with appropriate spillage of contrast.Incidentally, the right-sided essure coil does not appear to be within the right fallopian tube.Spinal x-ray - on (b)(6) 2015: findings/impression: five lumbar-type vertebral bodies are visualized.There is no acute fracture or traumatic subluxation.The bones are anatomically aligned.The vertebral body heights and disc spaces are well-maintained.There is a curvilinear density projecting over the right iliac wing, with a second density present on the lateral views.These may represent essure coils, although the one projecting over the right iliac wing appears far laterally positioned.Clinical correlation is recommended.Ultrasound pelvis - on (b)(6) 2012: impression: normal mid-cycle appearance.; on (b)(6) 2017: perforated essure coil.; on (b)(6) 2017: impression: 2 linear radiopaque densities are noted in the right lower quadrant consistent with migrated/mispositioned essure clips.One of these clips is noted immediately along the posterior wall of the cecum.A second clip is also noted along the posterior margin of the cecum but appears to extend into the cecal lumen by approximately 1.0 cm.No free fluid or air is seen.A 2mm, non-obstructing calculus in the right renal lower pole.Ultrasound scan vagina - on (b)(6) 2012: the right and left ovaries appear sonographically normal respectively measuring 2.4 x 2.0 x 1.6 cm, 4 cc, and 2.2 x 1.8 x 1.7 cm, 3.5 cc.A dominant follicle is seen in the left ovary measuring 12 x 11 x 11 mm.; on (b)(6) 2013: impression: endometrial stripe measures 3mm.No acute disease, no mass noted.; on (b)(6) 2015: impression: endometrial thickness measures 5mm.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: anxiety, abdominal pain, pelvic pain, nausea, headache, flank pain, irritable bowel syndrome, depression.Fatigue, lack of energy.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-apr-2019: quality safety evaluation of product technical complaint.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 tube(s))") and embedded device ("migration of essure device location of device: embedded in colon") in a 32-year-old 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 tonsillectomy.Previously administered products included for contraception: oral contraceptive nos from 2005 to (b)(6) 2018.Concurrent conditions included drug allergy.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, embedded device (seriousness criteria medically significant and intervention required), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), fatigue ("fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), constipation ("constipation"), diarrhoea ("diarrhea"), irritable bowel syndrome ("irritable bowel disorder (ibs)"), abdominal pain ("abdominal pain"), alopecia ("hair loss"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression"), stress ("stress"), weight increased ("weight gain"), pain in extremity ("leg pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (laparoscopic removal from my colon) and surgery (laparoscopic removal from my colon).Essure was removed in (b)(6) 2017.At the time of the report, the fallopian tube perforation, embedded device, bladder disorder, fatigue, alopecia, migraine, headache, pain in extremity and vulvovaginal pain outcome was unknown, the urinary tract disorder, abdominal distension, constipation, diarrhoea, irritable bowel syndrome, abdominal pain, anxiety, depression and stress had not resolved and the nausea and weight increased was resolving.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, bladder disorder, constipation, depression, diarrhoea, embedded device, fallopian tube perforation, fatigue, headache, irritable bowel syndrome, migraine, nausea, pain in extremity, stress, urinary tract disorder, vulvovaginal pain and weight increased to be related to essure.The reporter commented: current weight: 153 lbs approximate weight at the time of essure placement: 125 - 130 lbs.Diagnostic results: (b)(6) 2016 : hysterosalpingogram : bilateral fallopian tube potency, no association of dentified essure coil to the uterus or fallopian tubes / the doctor stated that the coils were not in my tubes.(b)(6) 2017 : ct abdomen pelvis with contrast : perforated essure coil.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-jul-2018: quality-safety evaluation of ptc(product technical complaint).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 fallopian tube perforation ("perforation (fallopian tube(s))") and device dislocation ("migration of essure device location of device: embedded in colon") in a 32-year-old female patient who had essure (batch no.731807) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included tonsillectomy, urodynamics measurement and prostate surgery.(b)(6)2013: mri of the lumbar spine - findings: no compression fracture, spondylolisthesis or marrow replacement process.No visualized intrathecal, para-spinal or retroperitoneal mass.Previously administered products included for contraception: oral contraceptive nos from 2005 to (b)(6)2019.Concurrent conditions included drug allergy, panic disorder, ovarian cyst, menses irregular, fibroids, vomiting, rib pain, cystitis, vaginal bleeding, dysmenorrhea, discharge vaginal, abdominal cramps, incontinence, menorrhagia, low back pain, trauma, anemia, arthritis, neuromuscular pain, dyspareunia, urinary incontinence aggravated, memory impaired, herniated disc, light headedness, chronic tonsillitis, sinusitis, ear ringing, swallowing difficult, slurred speech, emphysema, diabetes mellitus, gerd, glaucoma, gout, heart disease, unspecified, heart murmur, hepatitis c, hypertension, myocardial infarction, rash, upper respiratory infection, rheumatoid arthritis, seizures, sleep apnea, stroke, substance abuse, thyroid disorder, urinary tract infection, enteroenterostomy, sciatica, constipation, diarrhea, spondylosis, blurry vision, intestinal operation, tubal ligation (failed), dysuria and colitis.Concomitant products included amitriptyline, azithromycin (zithromax), clindamycin, codeine, ethinylestradiol;ferrous fumarate;norethisterone (femcon fe), hydrocodone, hydromorphone, ibuprofen, lorazepam, mirabegron (myrbetriq), oral contraceptive nos, oxybutynin, paracetamol (acetaminophen), simvastatin, topiramate, venlafaxine and vitamin d nos (vitamin d).In 2010, the patient experienced bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), nausea ("nausea"), pain in extremity ("leg pain") and vulvovaginal pain ("vaginal pain") and was found to have weight increased ("weight gain").On (b)(6)2010, the patient had essure inserted.In 2013, the patient experienced alopecia ("hair loss").In 2014, the patient experienced anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression") and stress ("stress").On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), constipation ("constipation"), diarrhoea ("diarrhea"), irritable bowel syndrome ("irritable bowel disorder (ibs)"), abdominal pain ("abdominal pain"), migraine ("migraines"), headache ("headaches/ back of my head pain") and complication of device insertion ("complications or problems that occurred at the time of your essure placement procedure: yes").The patient was treated with surgery (laparoscopic removal from my colon).Essure was removed on (b)(6)2017.At the time of the report, the fallopian tube perforation, device dislocation, bladder disorder, fatigue, migraine, headache, pain in extremity, vulvovaginal pain and complication of device insertion outcome was unknown, the urinary tract disorder, abdominal distension, constipation, diarrhoea, irritable bowel syndrome, abdominal pain, anxiety, depression and stress had not resolved and the alopecia, nausea and weight increased was resolving.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, bladder disorder, complication of device insertion, constipation, depression, device dislocation, diarrhoea, fallopian tube perforation, fatigue, headache, irritable bowel syndrome, migraine, nausea, pain in extremity, stress, urinary tract disorder, vulvovaginal pain and weight increased to be related to essure.The reporter commented: current weight: 153 lbs.Approximate weight at the time of essure placement: 125 - 130 lbs.Discrepancy noted in removal details: (b)(6)2017, (b)(6) 2017.Diagnostic results (normal ranges are provided in parenthesis if available): chest x-ray - on (b)(6)2013: impression: no acute pulmonary abnormality.No evidence of rib fracture.Computerised tomogram abdomen - on (b)(6)2017: impression: 1.Contracted versus collapse of the descending colon and sigmoid colon.Questionable wall thickening of the distal descending colon.Colitis is not excluded.There is no adjacent pericolonic stranding and no free fluid.2.3mm non-obstructing right renal stone, 3.Mild hepatomegaly versus riedel's lobe of the liver.Computerised tomogram head - on (b)(6)2015: impression: no acute intracranial hemorrhage or mass effect.Computerised tomogram pelvis - on (b)(6)2013: impression: 3.5 centimeter right ovarian cyst with trace free pelvic fluid, the remainder of the exam is normal.Computerised tomogram spine - on (b)(6)-2015: result: the cervical spine is in anatomic alignment.The odontoid process and lateral masses are intact.There are no acute fractures or traumatic list thesis.No loss of vertebral height or disc space narrowing.There is no narrowing of the spinal canal.No prevertebral soft tissue swelling.The neural foramina are patent.Hysterosalpingogram - on (b)(6)2016: bilateral fallopian tube potency, no association of identified essure coil to the uterus or fallopian tubes / the doctor stated that the coils were not in my tubes.; on (b)(6)2016: results: bilateral fallopian tube potency.Coils were not in my tubes.Findings: the scout radiograph reveals a right-sided essure coil projecting over the right iliac wing.The pelvis is otherwise unremarkable.The uterus is grossly normal.Contrast fills both fallopian tubes normally with appropriate spillage of contrast.Incidentally, the right-sided essure coil does not appear to be within the right fallopian tube.Spinal x-ray - on (b)(6)2015: findings/impression: five lumbar-type vertebral bodies are visualized.There is no acute fracture or traumatic subluxation.The bones are anatomically aligned.The vertebral body heights and disc spaces are well-maintained.There is a curvilinear density projecting over the right iliac wing, with a second density present on the lateral views.These may represent essure coils, although the one projecting over the right iliac wing appears far laterally positioned.Clinical correlation is recommended.Ultrasound pelvis - on (b)(6)2012: impression: normal mid-cycle appearance.; on (b)(6)2017: perforated essure coil.; on (b)(6)2017: impression: 1.2 linear radiopaque densities are noted in the right lower quadrant consistent with migrated/mispositioned essure clips.One of these clips is noted immediately along the posterior wall of the cecum.A second clip is also noted along the posterior margin of the cecum but appears to extend into the cecal lumen by approximately 1.0 cm.No free fluid or air is seen.2.A 2mm, non-obstructing calculus in the right renal lower pole.Ultrasound scan vagina - on (b)(6)2012: the right and left ovaries appear sonographically normal respectively measuring 2.4 x 2.0 x 1.6 cm, 4 cc, and 2.2 x 1.8 x 1.7 cm, 3.5 cc.A dominant follicle is seen in the left ovary measuring 12 x 11 x 11 mm.; on (b)(6)2013: impression: endometrial stripe measures 3mm.No acute disease, no mass noted.; on (b)(6)2015: impression: endometrial thickness measures 5mm.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: anxiety, abdominal pain, pelvic pain, nausea, headache, flank pain, irritable bowel syndrome, depression.Fatigue, lack of energy.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-apr-2019: pfs & mr received: lot no.Added.Reporter's information, patient demography, medical history, historical conditions, lab data and concomitant drugs were added.Severity of event ¿ vaginal pain, headache, legs pain were updated.Outcome of event hair loss was updated to recovering/resolving.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 tube(s))") and device dislocation ("migration of essure device location of device: embedded in colon") in a 32-year-old 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 tonsillectomy.Previously administered products included for contraception: oral contraceptive nos from 2005 to (b)(6) 2018.Concurrent conditions included drug allergy.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) with pelvic pain, device dislocation (seriousness criteria medically significant and intervention required), bladder disorder ("bladder problems or changes"), urinary tract disorder ("urinary problems or changes"), fatigue ("fatigue"), abdominal distension ("gastrointestinal or digestive system condition type: bloating"), constipation ("constipation"), diarrhoea ("diarrhea"), irritable bowel syndrome ("irritable bowel disorder (ibs)"), abdominal pain ("abdominal pain"), alopecia ("hair loss"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), anxiety ("psychological or psychiatric problems condition: anxiety"), depression ("psychological or psychiatric problems condition: depression"), stress ("stress"), weight increased ("weight gain"), pain in extremity ("leg pain"), vulvovaginal pain ("vaginal pain") and complication of device insertion ("complications or problems that occurred at the time of your essure placement procedure: yes").The patient was treated with surgery (laparoscopic removal from my colon).Essure was removed in (b)(6) 2017.At the time of the report, the fallopian tube perforation, device dislocation, bladder disorder, fatigue, alopecia, migraine, headache, pain in extremity, vulvovaginal pain and complication of device insertion outcome was unknown, the urinary tract disorder, abdominal distension, constipation, diarrhoea, irritable bowel syndrome, abdominal pain, anxiety, depression and stress had not resolved and the nausea and weight increased was resolving.The reporter considered abdominal distension, abdominal pain, alopecia, anxiety, bladder disorder, complication of device insertion, constipation, depression, device dislocation, diarrhoea, fallopian tube perforation, fatigue, headache, irritable bowel syndrome, migraine, nausea, pain in extremity, stress, urinary tract disorder, vulvovaginal pain and weight increased to be related to essure.The reporter commented: current weight: 153 lbs.Approximate weight at the time of essure placement: 125 - 130 lbs.Diagnostic results: on (b)(6) 2016: hysterosalpingogram: bilateral fallopian tube potency, no association of identified essure coil to the uterus or fallopian tubes / the doctor stated that the coils were not in my tubes.On (b)(6) 2017: ct abdomen pelvis with contrast: perforated essure coil.On (b)(6) 2016, were not in my tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-oct-2018: pfs received: event complications or problems that occurred at the time of your essure placement procedure: yes added.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.

• 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: 7388161
• MDR Text Key: 104069525
• Report Number: 2951250-2018-01384
• 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: health professional,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/02/2019

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: 04/01/2013
• Device Model Number: ESS305
• Device Lot Number: 731807
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 04/02/2018
• Supplement Dates Manufacturer Received: 07/24/2018; 10/10/2018; 04/16/2019; 04/26/2019
• Supplement Dates FDA Received: 08/01/2018; 10/16/2018; 04/24/2019; 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; ACETAMINOPHEN; AMITRIPTYLINE; AMITRIPTYLINE; CLINDAMYCIN; CLINDAMYCIN; CODEINE; CODEINE; FEMCON FE; FEMCON FE; HYDROCODONE; HYDROCODONE; HYDROMORPHONE; HYDROMORPHONE; IBUPROFEN; IBUPROFEN; LORAZEPAM; LORAZEPAM; MYRBETRIQ; MYRBETRIQ; ORAL CONTRACEPTIVE NOS; ORAL CONTRACEPTIVE NOS; OXYBUTYNIN; OXYBUTYNIN; SIMVASTATIN; SIMVASTATIN; TOPIRAMATE; TOPIRAMATE; VENLAFAXINE; VENLAFAXINE; VITAMIN D [VITAMIN D NOS]; VITAMIN D [VITAMIN D NOS]; ZITHROMAX; ZITHROMAX
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 32 YR