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

Model Number ESS305

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Separation Failure (2547)

Patient Problems Abdominal Pain (1685); Internal Organ Perforation (1987); Uterine Perforation (2121)

Event Date 09/14/2016

Event Type  Injury  

Event Description

This is a spontaneous case report received from other health professional in (b)(6) on 03-oct-2016 which refers to a female patient of unspecified age who had an attempt to get essure (fallopian tube occlusion insert) inserted on an unspecified date with lot number heo11f3.It was reported that implant did not discharge/ implants were not managed to insert to the patient.During essure insertion attempt arose a doubt about tubal perforation.The patient got kefexin for 3 days.Insertion procedure was not even tried to the other side.The patient has an appointment on (b)(6) to perform essure insertion or clips.Follow-up information received on 19-oct-2016 - perforation questionnaire received: the patient was an adult (>=18y & <65y).Medical history included gravida 2, 1 voluntary pregnancy termination and previous use of mirena.Concurrent conditions included obesity ((b)(6)).Essure was inserted on (b)(6) 2016 during follicular phase.Patient was not breastfeeding and there were no abnormal uterine findings.Mirena was removed during insertion.The insertion was difficult, as well as the visualization of the tubal os.Fluid loss was less than 1500cc, and the procedure did not take more than 20 minutes.Complaints immediately after insertion were just abdominal pain.The incorrect essure position was diagnosed on day of insertion via ultrasound.The partial perforation/embedment occurred unilateral right, and no other intra-abdominal structure was perforated.The left essure was in correct position.The essure insert could be removed only partially on (b)(6) 2016.Removal method: hysteroscopic.There were no pathology results, signs of infection or inflammation.The patient was prescribed antibiotics for 3 days (kefexin).The patient was scheduled to laparoscopic sterilization on (b)(6) 2016.It had been performed and patient was fine.The outcome was reported as recovered/resolved.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt to get essure (fallopian tube occlusion insert) inserted and initially a doubt about tubal perforation occurred during essure insertion attempt.It was confirmed that partial perforation of right tube occurred.The essure insert could be removed only partially.A hysteroscopic was performed.This event is serious due to its medical importance and anticipated in the reference safety information for essure.Uterine/fallopian perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage).Uterine/fallopian perforation with essure may occur, most often during insertion.Although the implant did not discharge and implants were not managed to insert to the patient, as the fallopian tube perforation occurred during essure insertion attempt, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident due to surgical intervention performed and partial device removal was required.A product technical analysis is being sought.

Manufacturer Narrative

Quality-safety evaluation of ptc (ptc global number: (b)(4)) received on 20-dec-2016: (b)(4).Date of manufacturer: 10-nov-2015.Expiration date: 28-nov-2018.Date of sample received at quality unit: 29-nov-2016.Detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: rollback to initial hard stop.Depress button.Perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.Visual inspection was performed and it was confirmed that all components are present, all ifu steps were completed, damages were observed on the delivery catheter tight pitch coil section (stretched).Inner catheter and delivery wire bonds were cured.In regards of visual inspection of delivery wire holder bond, hypo-tube to handle bond and the ptfe liner area were in conformance with acceptance criteria per inspection process, for dimensional inspection, due to the device condition no measurement was able to be performed.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, it is possible the essure device could have been defective prior to removal from the package.We also conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.The possibility of a detachment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue.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 medical events are known, possible, undesirable events and not indicative of a quality deficit per se.No similar ae case reports have been received to date in relation to the reported batch.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 21-dec-2016 for the following meddra preferred terms: pt: fallopian tube perforation: the analysis in the global safety database revealed 504 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt to get essure (fallopian tube occlusion insert) inserted and initially a doubt about tubal perforation occurred during essure insertion attempt.It was confirmed that partial perforation of right tube occurred.The essure insert could be removed only partially.A hysteroscopic was performed.This event is serious due to its medical importance and anticipated in the reference safety information for essure.Uterine/fallopian perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage).Uterine/fallopian perforation with essure may occur, most often during insertion.Although the implant did not discharge and implants were not managed to insert to the patient, as the fallopian tube perforation occurred during essure insertion attempt, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident due to surgical intervention performed and partial device removal was required.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.

Manufacturer Narrative

Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of ptc.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident at the time of reporting, 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• MDR Report Key: 6101509
• MDR Text Key: 59840249
• Report Number: 2951250-2016-02477
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Model Number: ESS305
• Device Lot Number: HE011F3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 80