MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problems Occlusion Within Device (1423); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Hemorrhage/Bleeding (1888); Pain (1994); Weakness (2145); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("abnormal appearance and malposition of right coil") and genital haemorrhage ("abnormal heavy bleeding") in a female patient who received essure for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient started essure.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and clinically significant/intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("severe abdominal pain"), back pain ("severe back pain"), fatigue ("fatigue") and asthenia ("weakness").The patient was treated with surgery (on (b)(6) 2015, essure removal surgery).Essure was withdrawn.On (b)(6) 2015, the patient experienced procedural pain ("following the removal surgery, she had a painful post-operative recovery").At the time of the report, the device dislocation, genital haemorrhage, abdominal pain, back pain, fatigue and asthenia outcome was unknown and the procedural pain had resolved.The reporter considered device dislocation, genital haemorrhage, abdominal pain, back pain, fatigue, asthenia and procedural pain to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2014: hysterosalpingogram result was complete occlusion of both fallopian tubes.In (b)(6) 2014: nuclear magnetic resonance imaging result was abnormal appearance, malposition of right coil (abnormal nos).Company causality comment: this non-medically confirmed spontaneous case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced device dislocation ("abnormal appearance and malposition of right coil") and genital haemorrhage ("abnormal heavy bleeding").Essure removal was performed.Additionally, non serious events were reported.Device dislocation and genital bleeding are anticipated events according to reference safety information for essure.During essure micro-insert therapy, device dislocation and changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.In this particular case, plaintiff experienced abdominal pain and na mri confirmed device was malpositioned.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these events and suspect insert cannot be excluded.This case was regarded as incident because surgical intervention was required due to serious injury.A product technical analysis has been sought.Follow-up information is expected only through the litigation process.

Manufacturer Narrative

Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 23-mar-2017: quality-safety evaluation of ptc was received.Company causality comment: this non-medically confirmed spontaneous case report refers to a female plaintiff who had essure (fallopian tube occlusion insert) inserted and experienced device dislocation ("abnormal appearance and malposition of right coil") and genital haemorrhage ("abnormal heavy bleeding").Essure removal was performed.Additionally, non serious events were reported.Device dislocation and genital bleeding are anticipated events according to reference safety information for essure.During essure micro-insert therapy, device dislocation and changes in bleeding pattern, including heavy and unscheduled bleedings, may occur within consumers under essure use.In this particular case, plaintiff experienced abdominal pain and na mri confirmed device was malpositioned.Thus, based on a positive temporal relationship and lack of alternative explanation, causality between these events and suspect insert cannot be excluded.This case was regarded as incident because surgical intervention was required due to serious injury.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.Follow-up information is expected only through the litigation process.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6428324
• MDR Text Key: 70693889
• Report Number: 2951250-2017-00971
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention