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

Catalog Number ESS305

Device Problem Activation, Positioning or SeparationProblem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This spontaneous case was reported by an other health professional and describes the occurrence of device deployment issue ("during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter") and complication of device insertion ("during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter") in a female patient who had essure (batch no. 50512918) inserted for female sterilization. On (b)(6) 2012, the patient had essure inserted. On the same day, the patient experienced device deployment issue and complication of device insertion. At the time of the report, the device deployment issue and complication of device insertion outcome was unknown. The reporter provided no causality assessment for complication of device insertion and device deployment issue with essure. The reporter commented: the material had to be removed by pulling on it, which could have damaged the tube. What was stuck in the tube included the green delivery catheter that sheaths the insert. After removal, i used another package to place another insert in order to ensure bilateral tubal sterilisation. 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 (pt). In this particular case a search in the global safety database was performed on (b)(6) 2017 for the following meddra pt: device deployment issue: n° 284 cases (excluding this case). 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 this meddra pt. Quality-safety evaluation of ptc: unable to confirm complaint. Most recent follow-up information incorporated above includes: on 20-oct-2017: quality-safety evaluation of ptc. 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 in a supplemental report.

Event Description

This spontaneous case was reported by an other health professional and describes the occurrence of device deployment issue ("during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter") and complication of device insertion ("during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter") in a female patient who had essure (batch no. 50512918) inserted for female sterilization. On (b)(6) 2012, the patient had essure inserted. On the same day, the patient experienced device deployment issue and complication of device insertion. At the time of the report, the device deployment issue and complication of device insertion outcome was unknown. The reporter provided no causality assessment for complication of device insertion and device deployment issue with essure. The reporter commented: the material had to be removed by pulling on it, which could have damaged the tube. What was stuck in the tube included the green delivery catheter that sheaths the insert. After removal, i used another package to place another insert in order to ensure bilateral tubal sterilisation. Company causality comment: this spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and during placement of the essure material in the patient's right uterine tube, the catheter remained stuck in the tube and the insert became unwound when i attempted to withdraw the catheter. This event, interpreted as device deployment issue, is anticipated in the reference safety information for essure. In the present case the event occurred during essure insertion procedure, therefore causality with essure cannot be excluded. Although there was no reported death or serious health deterioration, this might have occurred under less fortunate circumstances and therefore case was regarded as a reportable incident. A product technical analysis and further information are expected.

Manufacturer Narrative

On march 3, 2017, bayer received a cluster of essure complaint reports originating from the ansm, health authority of (b)(4), device vigilance database via legal proceedings. Following receipt, bayer consulted ansm in order to obtain the relevant case reference number information. On march 24, 2017, ansm provided the available corresponding case reference numbers to bayer. Upon receipt of this information bayer evaluated and processed the cluster of essure reports within the global safety database by april 12, 2017.

• 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: 6533560
• MDR Text Key: 253121676
• Report Number: 2951250-2017-01824
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: ESS305
• Device Lot Number: 50512918
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/20/2017
• 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