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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Pain (1994)

Event Date 09/14/2017

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain ("abdominal pain") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), diarrhoea ("diarrhea") and abdominal pain lower ("cramping").The patient was treated with surgery (unspecified on (b)(6) 2017).At the time of the report, the abdominal pain, diarrhoea and abdominal pain lower outcome was unknown.The reporter considered abdominal pain, abdominal pain lower and diarrhoea to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2016: satisfactory placement and full occlusion of tubes 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))"), device breakage ("device breakage") and abdominal pain ("abdominal pain") in a 33-year-old female patient who had essure (batch no.B53557) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included yeast infection, trichomonal vaginitis, kidney stones, migraine, hypertension, extracorporeal shock wave lithotripsy and induced abortion.Concurrent conditions included macroscopic hematuria.On (b)(6) 2015, the patient had essure inserted.On the same day, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2017, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), diarrhoea ("diarrhea"), abdominal pain lower ("cramping/left abdominal region pain") and complication of device insertion ("unable to place essure device in right fallopian tube").The patient was treated with dicycloverin hydrochloride (bentyl), surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (salpingectomy (bilateral removal of fallopian tubes)) and surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, device breakage, abdominal pain lower, dyspareunia and complication of device insertion had not resolved and the abdominal pain and diarrhoea outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, device breakage, diarrhoea, dyspareunia and fallopian tube perforation to be related to essure.The reporter commented: 4 coils were seen from the uterine side of the ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2016: satisfactory placement and full occlusion of tubes then total bilateral occlusion.Bilateral digital screening mammogram: findings- the breasts are heterogeneously dense, which may obscure small masses.Negative for malignancy.(b)(6) 2017, final pathologic diagnosis: 1.Left fallopian tube and essure: metallic coil consistent with essure device located in the subserosal tissue of the fallopian tube wall fallopian tube without atypia or neoplasm.2.Right fallopian tube: fallopian tube without atypia or neoplasm gross description: 1.Received in formalin labeled "patient, left fallopian tube and essure" is a brown-gray elastic cylindrical segment with fimbriated end consistent with fallopian tube.The specimen is 7 x 0.7 x 0.4cm.The fallopian tube surface is smooth.The serial sections exhibit a pinpoint lumen.0.2 cm from the proximal end the essure can be identified on the fallopian tube surface, 0.4 x 0.2 cm.Gross photographs are taken.The left fallopian tube fimbriated end is longitudinally bisected and entirely submitted in cassette a.Three cross-sections of the left fallopian tube are submitted in cassette b.The remaining fallopian tube is retained.2.Received in formalin labeled " patient, right fallopian tube" is an elastic cylindrical segment consistent with fallopian tube with attached fimbriated end.The fallopian tube is 5 x 0.5 x 0.5 cm.Serial sections exhibit a pinpoint lumen.The fimbriated end is longitudinally trisected and entirely submitted in cassette a.Cross-sections of the fallopian tube are submitted in cassette b.Gross photographs are taken.No essure is identified within this segment.(b)(6) 2017, abdomen and pelvis ct with contrast: impression- nonobstructing left intrarenal stone measuring 0.3 cm.Essure tubal occlusion device located within the peritoneal cavity in the anterior left lower quadrant, not within the left fallopian tube.In addition a right-sided tubal occlusion device is not seen.Based on these findings, definitive tubal occlusion cannot be confirmed on this study, trace free fluid in the pelvis, likely physiologic.(b)(6) 2017: ct scan: patient appears to have a free-floating metallic objects in the pelvis on the left-hand side where the use sure was placed.She also appears to have a small echogenic focus within the tube itself which the radiologist identifies is most likely calcium and not metal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 15-jun-2018: quality-safety evaluation of ptc.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of fallopian tube perforation ("perforation (fallopian tube(s))", device breakage ("device breakage") and abdominal pain ("abdominal pain") in a 33-year-old female patient who had essure (batch no.B53557) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included yeast infection, trichomonal vaginitis, kidney stones, migraine, hypertension, lithotripsy and induced abortion.Concurrent conditions included macroscopic hematuria.On (b)(6) 2015, the patient had essure inserted.On the same day, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2017, the patient experienced fallopian tube perforation (seriousness criteria medically significant and intervention required) and device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), diarrhoea ("diarrhea"), abdominal pain lower ("cramping/left abdominal region pain") and complication of device insertion ("unable to place essure device in right fallopian tube").The patient was treated with dicycloverine hydrochloride (bentyl), surgery (salpingectomy (bilateral removal of fallopian tubes)), surgery (salpingectomy (bilateral removal of fallopian tubes)) and surgery (salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2017.At the time of the report, the fallopian tube perforation, device breakage, abdominal pain lower, dyspareunia and complication of device insertion had not resolved and the abdominal pain and diarrhoea outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, complication of device insertion, device breakage, diarrhoea, dyspareunia and fallopian tube perforation to be related to essure.The reporter commented: 4 coils were seen from the uterine side of the ostium.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2016: satisfactory placement and full occlusion of tubes then total bilateral occlusion.Bilateral digital screening mammogram: findings- the breasts are heterogeneously dense, which may obscure small masses.Negative for malignancy.(b)(6) 2017, final pathologic diagnosis: 1.Left fallopian tube and essure: metallic coil consistent with essure device located in the subserosal tissue of the fallopian tube wall fallopian tube without atypia or neoplasm.2.Right fallopian tube: fallopian tube without atypia or neoplasm.Gross description: 1.Received in formalin labeled "patient, left fallopian tube and essure" is a brown-gray elastic cylindrical segment with fimbriated end consistent with fallopian tube.The specimen is 7 x 0.7 x 0.4cm.The fallopian tube surface is smooth.The serial sections exhibit a pinpoint lumen.0.2 cm from the proximal end the essure can be identified on the fallopian tube surface, 0.4 x 0.2 cm.Gross photographs are taken.The left fallopian tube fimbriated end is longitudinally bisected and entirely submitted in cassette a.Three cross-sections of the left fallopian tube are submitted in cassette b.The remaining fallopian tube is retained.2.Received in formalin labeled " patient, right fallopian tube" is an elastic cylindrical segment consistent with fallopian tube with attached fimbriated end.The fallopian tube is 5 x 0.5 x 0.5 cm.Serial sections exhibit a pinpoint lumen.The fimbriated end is longitudinally trisected and entirely submitted in cassette a.Cross-sections of the fallopian tube are submitted in cassette b.Gross photographs are taken.No essure is identified within this segment.(b)(6) 2017, abdomen and pelvis ct with contrast: impression- nonobstructing left intrarenal stone measuring 0.3 cm.Essure tubal occlusion device located within the peritoneal cavity in the anterior left lower quadrant, not within the left fallopian tube.In addition a right-sided tubal occlusion device is not seen.Based on these findings, definitive tubal occlusion cannot be confirmed on this study, trace free fluid in the pelvis, likely physiologic.(b)(6) 2017: ct scan: patient appears to have a free-floating metallic objects in the pelvis on the left-hand side where the use sure was placed.She also appears to have a small echogenic focus within the tube itself which the radiologist identifies is most likely calcium and not metal.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet and medical records received: reporters details added.Event added as device breakage, dyspareunia (painful sexual intercourse), pain, perforation (fallopian tube(s)), and unable to place essure device in right fallopian tube.Case medically confirmed.Lot number and relevant lab data 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.

• 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: 7376479
• MDR Text Key: 103650539
• Report Number: 2951250-2018-01300
• 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
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: ESS305
• Device Lot Number: B53557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR