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); Migration (4003)

Patient Problems Anemia (1706); Headache (1880); Swelling (2091); Bowel Perforation (2668); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/24/2008

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) 2008, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain and pelvic pain, swelling ("swelling"), headache ("headaches") and anaemia ("anemia").The patient was treated with surgery (surgery to remove the essure on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, swelling, headache and anaemia outcome was unknown.The reporter considered anaemia, device breakage, headache and swelling 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 dislocation ('migration of essure device location of device : piece of device found embedded in stomach'), device breakage ('fracturing of the implant / device breakage') and gastrointestinal perforation ('perforation: abdomen') in a 42-year-old female patient who had essure (batch no.627291,619696) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included diabetes since 2017 and hypertension since 2017.Concomitant products included ferrous sulfate from 2008 to 2017, lisinopril since 2017 and metformin since 2017.On (b)(6) 2008, the patient had essure inserted.In 2008, the patient experienced visual impairment ("vision / eye problems - type - worsening vision").In (b)(6) 2008, the patient experienced anaemia ("anemia"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), arthralgia ("pain: joint"), fatigue ("fatigue") and alopecia ("hair loss").On (b)(6) 2008, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain and pelvic pain, 2 months 29 days after insertion of essure.On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and gastrointestinal perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced swelling ("swelling") and headache ("headaches").The patient was treated with surgery (hysterectomy (full) with bilateral salpingectomy to remove the essure on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, gastrointestinal perforation, swelling, headache, nausea, dysmenorrhoea, fatigue and alopecia outcome was unknown, the anaemia, menorrhagia, vaginal haemorrhage and arthralgia had resolved and the visual impairment was resolving.The reporter considered alopecia, anaemia, arthralgia, device breakage, device dislocation, dysmenorrhoea, fatigue, gastrointestinal perforation, headache, menorrhagia, nausea, swelling, vaginal haemorrhage and visual impairment to be related to essure.No further causality assessment were provided for the product.The reporter commented: dates of insertion: (b)(6) 2008 and (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: unilateral occlusion (left tube occluded) , breakage of essure device, migration of essure device.-essure device projected over the right sacrum.A separate 1 to 2 mm linear density which appears.To be a portion of an essure device projects immediately adjacent to the curvilinear normal appearing essure device.A second essure sterilization device is not identified in the pelvis of throughout the remainder of the abdomen, all of which was imaged.-there is no free spillage of contrast from the visualized right fallopian tube.The full right fallopian tube is not visualized, hs the fimbriated and ampullary portions of the tube are not fully seen.Lot number:619696 manufacture date: 2009-02, expiration date: 2012-02.Lot number:627291 manufacture date: 2008-05, expiration date: 2010-05.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-jun-2019: quality safety evaluation of ptc(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 dislocation ('migration of essure device location of device : piece of device found embedded in stomach'), device breakage ('fracturing of the implant / device breakage') and gastrointestinal perforation ('perforation: abdomen') in a 42-year-old female patient who had essure (batch no.627291,619696) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included diabetes since 2017 and hypertension since 2017.Concomitant products included ferrous sulfate from 2008 to 2017, lisinopril since 2017 and metformin since 2017.In 2008, the patient experienced visual impairment ("vision / eye problems - type - worsening vision").In (b)(6) 2008, the patient experienced anaemia ("anemia"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), nausea ("nausea"), dysmenorrhoea ("dysmenorrhea (cramping)"), arthralgia ("pain: joint"), fatigue ("fatigue") and alopecia ("hair loss").On (b)(6) 2008, the patient had essure inserted.On (b)(6) 2008, the patient experienced device breakage (seriousness criteria medically significant and intervention required) with abdominal pain and pelvic pain, 2 months 29 days after insertion of essure.On (b)(6) 2017, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) and gastrointestinal perforation (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced swelling ("swelling") and headache ("headaches").The patient was treated with surgery (hysterectomy (full) with bilateral salpingectomy to remove the essure on (b)(6) 2017).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, device breakage, gastrointestinal perforation, swelling, headache, nausea, dysmenorrhoea, fatigue and alopecia outcome was unknown, the anaemia, menorrhagia, vaginal haemorrhage and arthralgia had resolved and the visual impairment was resolving.The reporter considered alopecia, anaemia, arthralgia, device breakage, device dislocation, dysmenorrhoea, fatigue, gastrointestinal perforation, headache, menorrhagia, nausea, swelling, vaginal haemorrhage and visual impairment to be related to essure.The reporter commented: dates of insertion: (b)(6) 2008 and (b)(6) 2009.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2008: -unilateral occlusion (left tube occluded) , breakage of essure device, migration of essure device.Essure device projected over the right sacrum.A separate 1 to 2 mm linear density which appears.To be a portion of an essure device projects immediately adjacent to the curvilinear normal appearing essure device.A second essure sterilization device is not identified in the pelvis of throughout the remainder of the abdomen, all of which was imaged.There is no free spillage of contrast from the visualized right fallopian tube.The full right fallopian tube is not visualized, hs the fimbriated and ampullary portions of the tube are not fully seen.Most recent follow-up information incorporated above includes: on 13-jun-2019: pfs and mr received : this is a medically confirmed case.Reporter information was added.Patient details were added and updated.Lab data was added.Essure insertion date was updated.Essure lot number was added.Her concomitant medications were added.Per plaintiff fact sheet following events: piece of device found embedded in stomach, perforation: abdomen, abnormal bleeding (vaginal, menorrhagia), nausea, dysmenorrhea (cramping), pain: joint and worsening vision were added.She had recovered from event: pain: joint, abnormal bleeding (vaginal, menorrhagia), anemia and recovering from event: vision changes.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: 7056356
• MDR Text Key: 92867236
• Report Number: 2951250-2017-08260
• 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: 06/24/2019

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 Model Number: ESS305
• Device Lot Number: 627291,619696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/13/2019; 06/21/2019
• Supplement Dates FDA Received: 06/19/2019; 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FERROUS SULFATE; FERROUS SULFATE; LISINOPRIL; LISINOPRIL; METFORMIN; METFORMIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR