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

Model Number ESS305

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); 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 ("fragmentation of device / it looks like pieces of metal to me") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant).At the time of the report, the device breakage outcome was unknown.The reporter considered device breakage 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

Spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fragmentation of device / it looks like pieces of metal to me") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant).At the time of the report, the device breakage outcome was unknown.The reporter considered device breakage to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-oct-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 device breakage ('fragmentation of device / it looks like pieces of metal to me') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), pelvic congestion ("pelvic congestion"), spinal osteoarthritis ("spondylosis"), back pain ("back ache"), adenomyosis ("adenomyosis"), facet joint syndrome ("face joint disease"), coccydynia ("pain tailbone"), arthralgia ("hip pain") and inflammation ("inflammation").The patient was treated with surgery (hysterectomy, removed laproscopically).Essure was removed in (b)(6) 2013.At the time of the report, the device breakage, pelvic congestion, spinal osteoarthritis, back pain, adenomyosis, facet joint syndrome, coccydynia, arthralgia and inflammation outcome was unknown.The reporter considered adenomyosis, arthralgia, back pain, coccydynia, device breakage, facet joint syndrome, inflammation, pelvic congestion and spinal osteoarthritis to be related to essure.The reporter commented: plaintiff had ablation after removal.Concerning the injuries reported in this case the following were reported via social media- facet joint disease, pain tailbone, hip pain, congestion, spondylosis, back ache, adenomyosis, inflammation.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: social media content received: reporter added.Events: pelvic congestion, spondylosis, back ache, adenomyosis added.Fu 5 and 6 processed together.On 23-mar-2020: social media received.Event added- facet joint disease, pain tailbone, hip pain.Reporter information was added.Fu 5 and 6 processed together.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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: 7650165
• MDR Text Key: 113170727
• Report Number: 2951250-2018-02905
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 10/30/2018; 10/30/2018
• Supplement Dates FDA Received: 10/30/2018; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention