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

Model Number ESS305

Device Problems Unintended Ejection (1234); Fracture (1260); Physical Resistance (2578)

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

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(4) 2014 which refers to a (b)(6) female pt who had essure (fallopian tube occlusion insert) inserted and experienced the adverse events as described below: pt's last menstrual period before essure insertion was on (b)(6) 2014, she used condoms as birth control and urine pregnancy test performed before the procedure was negative.Concomitant medications included xanax 1mg and vicodin.No medical history.Pt was a nonsmoker, sexually active and her gynecological history included gravida 2, parity 2 (2002 and 2007), periods every 21 days.Her last pap smear was in 2012; she had an abnormal pap smear in 1996 with hpv1/precancerous cells.No known drug allergies.Pt had pending f/u of bloody diarrhea, which has resolved.Physician reported that essure was inserted on (b)(6) 2014 with lot number # b61391 (expiration date in 08/2016) for female sterilization.During the procedure blood pressure was 128/88, pulse 72, temperature 37.01 celsius degree and pt received toradol, ketorolac 60mg intra-muscular and valium 10mg (oral).Paracervical block was performed using 22 gauge spinal needle and 22cc of fentanyl/naropin and lidocaine.During essure insertion, the left tube was cannulated and device deployed without issue.However, on the right tube upon deployment a portion of the implant was ejected.Initially thought to be the entire implant a second implant was attempted to be deployed and the tube was cannulated with slight resistance but upon deployment the entire implant ejected.Physician removed the two implants and upon further investigation and removal of the ejected material, it was noted that the first implant was actually only a portion of the device.Upon extracorporeal inspection it was noted the first implant was fractured and only approximately 5 coils were noted compared to the full length of th e second device.After this instigation, the physician performed a further inspection into the ostia with full distention.At this time it was noted that 2 coils were seen and the device was actually in place with the implant in the ostia.Physician mentioned that the pt was fully informed as the procedure was underway and did not believe she was harmed in any way and believed that the partial implant should function as anticipated as only 5 coils were broken and 2 were seen in the ostia.Physician left 4 coils on the left and 2 on the right.Cipro 1 tablet 500mg, orally, every 12 hrs, 3 days was given due to increased instrumentation.Pt would have a follow up visit for essure total occlusion confirmation via hsg (hysterosalpingogram) in 3 months.Ptc investigation result was received on (b)(4) 2014.This adverse event report is related to a product technical complaint (ptc).The bayer ref.Number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: since no product was returned for investigation, we cannot confirm this quality complaint; however, based on the complaint description provided, we are able to conclude that a quality issue is plausible.It is possible during the mfg assembly process a small gap was left between the inner coil and inner catheter (they should be butted together during assembly).When the outer coil of the micro-insert is wound down a small portion of the coil can become trapped in the gap.If a device has this issue, when the physician presses the button to release the micro-insert, the outer coil may sever itself as it is being deployed from the catheter.In typical situations, this severing occurs inside the catheter prior to the pieces being deployed from the catheter.The severing of the coils inside the catheter does not pose a significant risk to the health of the pt.Medical assessment: one (1) additional ae case report has been received to date in relation to batch number b61391 but this case did not refer to a similar breakage event or deployment issue.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for a technical investigation.According to the technical assessment a quality defect was plausible based on the complaint description and based on the provided info the defect type corresponds to the following meddra llt device breakage.At time of this medical assessment the technical investigation concluded "unconfirmed quality defect - but plausible" with a final risk category iv, a defect which does not pose a hazard to pt's health as the severing of the coils does not pose a significant risk to the health of th e pt.In summary, based on the available info of the device breakage and a product defect, a causal relationship can not be excluded.Company causality comment: this medically confirmed, spontaneous case report, refers to a (b)(6) female pt who had essure (fallopian tube occlusion insert) inserted and during the procedure on the right tube upon deployment a portion of the implant was ejected (first implant); the first implant fractured (approximately 5 coils broken)/ complication of device insertion; second implant cannulated with slight resistance an dupon deployment the entire implant ejected (second implant).Reporter causality was not provided.All reported events are non-serious.The event the first implant fractured (approx.5 coils broken) interpreted as a device breakage; is unlisted on the reference safety info for essure and was considered a near-incident, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The remaining events are listed and non-incidents.Single cases of essure breakage have been reported.In this particular case, the physician had difficulties during right insert deployment (at first attempt he believed the entire insert was ejected and tried to place another one, which was also ejected.Further, upon extracorporeal inspection of the ejected inserts it was seen that the first one was broken (approximately 5 coils); and its remaining portion was actually in place with 2 coils visualized in the right tubal ostia.The physician believed that no harm occurred to the pt and that the second device malfunctioned due to the presence of the first one in tube.As the reported events occurred in association with essure placement procedure, their causal relationship with the suspect insert cannot be excluded.According to product technical complaint investigation results, the technical investigation concluded "unconfirmed quality defect -but plausible." in summary, based on the available info of the device breakage and a product defect a causal relationship cannot be excluded.

Manufacturer Narrative

Data correction for us reporting.The code (b)(4) was replaced with (b)(4).

• 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: 4019723
• MDR Text Key: 19407566
• Report Number: 2951250-2014-00259
• 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,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B61391
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: NAROPIN (ROPIVACAINE HYDROCHLORIDE); FENTANYL (FENTANYL); LIDOCAINE (LIDOCAINE); IBUPROFEN (IBUPROFEN [IBUPROFEN]) TABLET; PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET; TORADOL (KETOROLAC TROMETHAMINE); VALIUM (DIAZEPAM); VICODIN (VICODIN) TABLET UNK
• Patient Age: 36 YR