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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994); Rash (2033); Abdominal Cramps (2543); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), abdominal pain lower ("crampings"), pain in extremity ("unbearable pains in legs") and back pain ("back pain").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, rash, abdominal pain lower, pain in extremity and back pain outcome was unknown.The reporter considered abdominal pain lower, back pain, device breakage, pain in extremity and rash to be related to essure.Further company follow-up with the consumer 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 device breakage ("fracturing of the implant") in an adult female patient who had essure (batch no.C18710) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) - no".Concomitant products included medroxyprogesterone acetate (depoprovera).On (b)(6)2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), abdominal pain lower ("cramping's / left side"), pain in extremity ("unbearable pains in legs / left leg pain"), back pain ("back pain / lower back"), dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pelvic pain").The patient was treated with surgery (laparoscopic bilateral salpingectomy, hysteroscopy).Essure was removed on (b)(6)2018.At the time of the report, the device breakage, rash, back pain, dysmenorrhoea and pelvic pain outcome was unknown and the abdominal pain lower and pain in extremity had resolved.The reporter considered abdominal pain lower, back pain, device breakage, dysmenorrhoea, pain in extremity, pelvic pain and rash to be related to essure.The reporter commented: 3 to 4 coils were visible at the tubal ostia on each side.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6)2018: a.Fallopian tube.Left, salpingectomy: fallopian tube with no diagnostic abnormalities recognized.B.Fallopian tube, right, salpingectomy: fallopian tube with no diagnostic abnormalities recognized.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records : pelvic pain.Batch no c18710, production date 2014-01-29, expiration date 2017-01- 31.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer or consumer is not possible.Most recent follow-up information incorporated above includes: on 25-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 device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), abdominal pain lower ("crampings"), pain in extremity ("unbearable pains in legs") and back pain ("back pain").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, rash, abdominal pain lower, pain in extremity and back pain outcome was unknown.The reporter considered abdominal pain lower, back pain, device breakage, pain in extremity and rash to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on 27-jun-2018: quality-safety evaluation of ptc.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 device breakage ("fracturing of the implant") in an adult female patient who had essure (batch no.C18710) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included medroxyprogesterone acetate (depoprovera).On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), abdominal pain lower ("crampings"), pain in extremity ("unbearable pains in legs") and back pain ("back pain").The patient was treated with surgery (laparoscopic bilateral salpingectomy, hysteroscopy).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, rash, abdominal pain lower, pain in extremity and back pain outcome was unknown.The reporter considered abdominal pain lower, back pain, device breakage, pain in extremity and rash to be related to essure.The reporter commented: 3 to 4 coils were visible at the tubal ostia on each side.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2018: fallopian tube.Left, salpingectomy: fallopian tube with no diagnostic abnormalities recognized.Fallopian tube, right, salpingectomy: fallopian tube with no diagnostic abnormalities recognized.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer or consumer is not possible.Most recent follow-up information incorporated above includes: on 17-apr-2019: pfs and mr received.Reporter information were added.Lot number were added.Concomitant drug and lab data were added.Insertion date were updated.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 device breakage ("fracturing of the implant") in an adult female patient who had essure (batch no.C18710) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test(s) - no".Concomitant products included medroxyprogesterone acetate (depoprovera).On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), abdominal pain lower ("crampings / left side"), pain in extremity ("unbearable pains in legs / left leg pain"), back pain ("back pain / lower back"), dysmenorrhoea ("dysmenorrhea (cramping)") and pelvic pain ("pelvic pain").The patient was treated with surgery (laparoscopic bilateral salpingectomy, hysteroscopy).Essure was removed on (b)(6) 2018.At the time of the report, the device breakage, rash, back pain, dysmenorrhoea and pelvic pain outcome was unknown and the abdominal pain lower and pain in extremity had resolved.The reporter considered abdominal pain lower, back pain, device breakage, dysmenorrhoea, pain in extremity, pelvic pain and rash to be related to essure.The reporter commented: 3 to 4 coils were visible at the tubal ostia on each side.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2018: a.Fallopian tube.Left, salpingectomy: fallopian tube with no diagnostic abnormalities recognized.B.Fallopian tube, right, salpingectomy: fallopian tube with no diagnostic abnormalities recognized.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records : pelvic pain.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer, lawyer, lawyer, lawyer or consumer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Events dysmenorrhea (cramping), pelvic pain and essure confirmation test(s) ¿ no 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: 7421906
• MDR Text Key: 105177794
• Report Number: 2951250-2018-01684
• 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,Followup
• Report Date: 04/25/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: ESS305
• Device Lot Number: C18710
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 04/17/2019; 04/19/2019; 04/25/2019
• Supplement Dates FDA Received: 07/04/2018; 04/22/2019; 04/24/2019; 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPOPROVERA; DEPOPROVERA; DEPOPROVERA
• Patient Outcome(s): Other; Required Intervention