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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Anemia (1706); Hemorrhage/Bleeding (1888); Tissue Damage (2104); Disability (2371)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (mw# 5041996) in united states on 23-jun-2015 who had essure (fallopian tube occlusion insert) inserted on an unspecified date.Consumer stated that she experienced bleeding for over a year, became anemic and had to have a hysterectomy as one coil was missing.Nothing was wrong with her before essure and nothing wrong after everything was taken out.She also experienced pain.Concomitant medication included women´s one a day vitamin.No further information was provided.Follow-up received on 01-jul-2015: product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint and was initiated due to a request for confirmation of quality.(b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to look for any manufacturing deficiencies.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.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events considered related are known possible undesirable events and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample was available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced excessive bleeding (seen as genital bleeding).It was reported that one coil was missing (seen as device dislocation).A hysterectomy was performed.Both event are serious due to medical importance and listed in the reference safety information for essure.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).Also, genital bleeding may occur during and following the micro-insert placement procedure.In this particular case, the exact date and mechanism of dislocation were not known.It was reported that consumer bleed for over a year and became anemic.No alternative explanation was provided.Given their nature, a causal relationship between these events with essure therapy cannot be excluded.This case was regarded as incident due to required intervention.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 4928873
• MDR Text Key: 6434429
• Report Number: 2951250-2015-00528
• 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: Other,Consumer,consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

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
• Initial Date Manufacturer Received: 06/23/2015
• Initial Date FDA Received: 07/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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