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

Model Number ESS305

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Pain (1994); Anxiety (2328); 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 (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain") and anxiety ("anxiety").The patient was treated with surgery (to remove essure implant).Essure was removed in (b)(6) 2014.At the time of the report, the device breakage, pelvic pain and anxiety outcome was unknown.The reporter considered anxiety, device breakage and pelvic pain to be related to essure.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.827927) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included vital functions abnormal, mental status changes postoperative, nausea and vomiting.Concomitant products included nitrofurantoin, nsaids and phenazopyridine hydrochloride (pyridium).On (b)(6)2011, the patient had essure inserted.In 2011, the patient experienced pelvic pain ("pain"), dysmenorrhoea ("dysmenorrhea (cramping),") and dyspareunia ("dyspareunia (painful sexual intercourse),").In 2012, the patient experienced vulvovaginal dryness ("vaginal dryness").In (b)(6)2014, the patient experienced urinary tract infection ("infection: urinary tract infections").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), procedural pain ("through the confirmation test, they had to stop immediately.It was horribly painful."), adnexa uteri pain ("ovaries pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (to remove essure implant, salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6)2014.At the time of the report, the device breakage, pelvic pain, anxiety, procedural pain, dysmenorrhoea, dyspareunia, urinary tract infection, vulvovaginal dryness, adnexa uteri pain and vulvovaginal pain outcome was unknown.The reporter considered adnexa uteri pain, anxiety, device breakage, dysmenorrhoea, dyspareunia, pelvic pain, procedural pain, urinary tract infection, vulvovaginal dryness and vulvovaginal pain to be related to essure.The reporter commented: unable to place a right essure device due to either tubal spasm or tubal blockage.Rt ear sx for tm perforation.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - in 2011: results: unilateral occlusion (left tube occluded).Most recent follow-up information incorporated above includes: on 26-feb-2019: medical records received: lot number was added.Reporters were added.Concomitant conditions were added.Concomitant drug was added.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

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 inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), anxiety ("anxiety"), procedural pain ("through the confirmation test, they had to stop immediately.It was horribly painful."), dysmenorrhoea ("dysmenorrhea (cramping),"), dyspareunia ("dyspareunia (painful sexual intercourse),"), urinary tract infection ("infection: urinary tract infections"), vulvovaginal dryness ("vaginal dryness"), adnexa uteri pain ("ovaries pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (to remove essure implant).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage, pelvic pain, anxiety, procedural pain, dysmenorrhoea, dyspareunia, urinary tract infection, vulvovaginal dryness, adnexa uteri pain and vulvovaginal pain outcome was unknown.The reporter considered adnexa uteri pain, anxiety, device breakage, dysmenorrhoea, dyspareunia, pelvic pain, procedural pain, urinary tract infection, vulvovaginal dryness and vulvovaginal pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - in 2011: unilateral occlusion (left tube occluded).Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs+mr received: new events: dysmenorrhoea, dyspareunia, urinary tract infection, vulvovaginal dryness, adnexa uteri pain, vulvovaginal pain, procedural pain, reporter, concomitant diseases added.Product start date, stop date updated.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.827927) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included vital functions abnormal, mental status changes postoperative, nausea and vomiting.Concomitant products included nitrofurantoin, nsaids and phenazopyridine hydrochloride (pyridium).On (b)(6) 2011, the patient had essure inserted.In 2011, the patient experienced pelvic pain ("pain"), dysmenorrhoea ("dysmenorrhea (cramping),") and dyspareunia ("dyspareunia (painful sexual intercourse),").In 2012, the patient experienced vulvovaginal dryness ("vaginal dryness").In (b)(6) 2014, the patient experienced urinary tract infection ("infection: urinary tract infections").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), anxiety ("anxiety"), procedural pain ("through the confirmation test, they had to stop immediately.It was horribly painful."), adnexa uteri pain ("ovaries pain") and vulvovaginal pain ("vaginal pain").The patient was treated with surgery (to remove essure implant, salpingectomy (bilateral removal of fallopian tubes)).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage, pelvic pain, anxiety, procedural pain, dysmenorrhoea, dyspareunia, urinary tract infection, vulvovaginal dryness, adnexa uteri pain and vulvovaginal pain outcome was unknown.The reporter considered adnexa uteri pain, anxiety, device breakage, dysmenorrhoea, dyspareunia, pelvic pain, procedural pain, urinary tract infection, vulvovaginal dryness and vulvovaginal pain to be related to essure.The reporter commented: unable to place a right essure device due to either tubal spasm or tubal blockage.Rt ear sx for tm perforation.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound scan vagina - in 2011: results: unilateral occlusion (left tube occluded).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-may-2019: quality safety evaluation for ptc.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: 7056566
• MDR Text Key: 92914806
• Report Number: 2951250-2017-08415
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/03/2019

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: 02/01/2014
• Device Model Number: ESS305
• Device Lot Number: 827927
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/13/2018; 02/26/2019; 05/27/2019
• Supplement Dates FDA Received: 07/13/2018; 03/06/2019; 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NITROFURANTOIN; NITROFURANTOIN; NSAIDS; NSAIDS; PYRIDIUM; PYRIDIUM
• Patient Outcome(s): Other; Required Intervention