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

Model Number ESS305

Device Problem Material Fragmentation (1261)

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

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 06-may-2016 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted for over a year, for contraception.On an unspecified date, hsg (hysterosalpingogram) was done and occlusion was present.On an unspecified date, ct (computed tomography) scan was done and showed that one essure was fragmented.Essure was not removed.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and over a year later a ct (computed tomography) scan showed one essure was fragmented.This event, interpreted as device breakage, is non-serious and unlisted in the reference safety information for essure.In the present case, limited information was provided.Hysterosalpingogram performed after insertion showed occlusion.An unspecified time later a ct scan showed one essure was fragmented.The exact date and mechanism of the device breakage were not specified.Given the nature of this event, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.A product technical analysis and further information are expected.

Manufacturer Narrative

Follow-up information received on 20-jun-2016: quality-safety evaluation of product technical complaint: the bayer reference number for the ptc report is (b)(4).A hysterosalpingogram (hsg) is an x-ray test that looks at the inside of the uterus and fallopian tubes and the area around them.During an hsg, a dye (contrast material) is put through a thin tube that is put through the vagina and into the uterus.For essure, a modified hsg is performed using a slow-fill of contrast.The essure confirmation test (modified hsg) is performed three months post-placement to evaluate insert location and fallopian tube occlusion.Hsg films should be reviewed and interpreted by a trained medical professional, such as a physician or radiologist.In many hsg images, only the radiopaque markers located on the micro-insert are visible.In some cases, the micro-insert can be stretched by muscular contractions of the fallopian tube.When viewed on an hsg image, this may contribute to the perception that the device is broken since the distance between radiopaque markers is longer than anticipated; however, the device is not actually broken.Since the remaining parts of the device are not visible, hsg images can be misinterpreted as being broken or fragmented.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, it is possible the essure device could have been defective prior to removal from the package.The possibility of the catheter, micro-insert, or introducer breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the available information a product quality defect could not be confirmed but is considered plausible.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.Since no medical events and no batch number were reported, a batch investigation with respect to similar ae cases is not applicable.Since no medical events were reported at this point in time, the assessment of a relationship with a quality defect is not applicable.Follow-up received on 27-jun-2016: the letter sent to health care professional was returned undelivered.Company was unable to contact reporter since no information available.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and over a year later a ct (computed tomography) scan showed one essure was fragmented.This event, interpreted as device breakage, is non-serious and unlisted in the reference safety information for essure.However according to product investigation is anticipated.In the present case, limited information was provided.Hysterosalpingogram performed after insertion showed occlusion.An unspecified time later a ct scan showed one essure was fragmented.The exact date and mechanism of the device breakage were not specified.Given the nature of this event, a causal relationship with essure cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.A product technical analysis concluded, based on the available information a product quality defect could not be confirmed but is considered plausible despite follow-up attempt, no further information was obtained.

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: 5694932
• MDR Text Key: 46417585
• Report Number: 2951250-2016-00740
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• 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