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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2016

Event Type  Injury  

Event Description

This spontaneous case report was received from a gynecologist/obstetrician in the united states on (b)(6) 2016.The report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on an unspecified date.On an unspecified date, the hcp (healthcare professional) performed a hysterectomy because she had one coil protruding through the uterus.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and one coil was protruding through uterus.She had a hysterectomy due to this event.This protrusion, seen as device dislocation, is anticipated according to essure's reference safety information.Although in this case the exact circumstances and mechanism of this dislocation were not provided, given its nature per se, causal relationship between the reported event and essure device cannot be excluded.Since a surgical intervention was required, this case is regarded as incident.Technical analysis and further information have been requested.

Manufacturer Narrative

Quality safety evaluation of ptc received on 09-dec-2016: ptc global number (b)(4).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.No specific quality issue was defined, therefore no meddra llt can be provided.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 event is a known, possible, undesirable event and not indicative of a quality deficit per se.Since no bath number was reported, a batch investigation with respect to similar ae cases is not applicable.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and one coil was protruding through uterus.She had a hysterectomy due to this event.This protrusion, seen as device dislocation, is anticipated according to essure's reference safety information.Although in this case the exact circumstances and mechanism of this dislocation were not provided, given its nature per se, causal relationship between the reported event and essure device cannot be excluded.Since a surgical intervention was required, this case is regarded as incident.A product quality defect could not be confirmed but is considered plausible.Further information has been requested.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of fallopian tube perforation ("one coil protruding through the uterus cornua / partial perforation unilateral left") in a (b)(6) female patient who received essure.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multi gravida, parity 2, termination of pregnancy - elective and endometrial curettage.No c-sections and no spontaneous abortions.On (b)(6) 2013, the patient started essure.On (b)(6) 2016, 1013 days after starting essure, the patient experienced fallopian tube perforation (seriousness criteria medically significant and clinically significant/intervention required) with abdominal pain and device difficult to use ("unable to remove essure via laparoscopy").The patient was treated with surgery (vaginal hysterectomy).Essure was withdrawn.At the time of the report, the fallopian tube perforation and device difficult to use had resolved.The reporter provided no causality assessment for fallopian tube perforation and device difficult to use with essure.The reporter commented: essure was inserted during luteal phase.Cervical dilatation was applied during insertion.Insertion and visualization of tubal os was easy.No fluid loss during hysteroscopy over 1500cc.No complaints immediately after insertion.Diagnostic results (normal ranges are provided in parenthesis if available): on (b)(6) 2014: hysterosalpingogram result was tubal occlusion.Most recent follow-up information incorporated above includes: on 11-jan-2017: uterine / tubal perforation with essure questionnaire received.Historical conditions, tests, start date of essure and events added.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and one coil protruding through the uterus cornua (partial perforation unilateral left).She had a hysterectomy due to this event and coils were removed more than 3 years after insertion procedure.This event is anticipated according to essure's reference safety information.In this present case, the partial perforation was diagnosed approximately 3 years after insertion.Although in this case the exact circumstances and mechanism of this perforation were not provided, given its nature per se, causal relationship between the reported event and essure device cannot be excluded.Since a surgical intervention was required, this case is regarded as incident.A product quality defect could not be confirmed but is considered plausible.No further information is expected.

• 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: 6148807
• MDR Text Key: 61545827
• Report Number: 2951250-2016-02643
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2017

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?: Yes
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/04/2017; 01/30/2017
• 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
• Patient Age: 29 YR
• Patient Weight: 50