MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problems Bent (1059); Break (1069); Difficult To Position (1467); Material Separation (1562); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 05/11/2014

Event Type  No Answer Provided  

Event Description

This is a spontaneous case report received form a nurse in united states on (b)(6) 2014 which refers to a females pt of unspecified age who received essure (fallopian tube occlusion insert) and experienced two coils-both failed to do it's job, springs came apart and pt has coil in only one side and device insertion complication.No information given on pt's history, past drugs and concurrent conditions.It was not reported whether the pt received any concomitant medication.On (b)(6) 2014, the pt had essure (fallopian tube occlusion insert) inserted, lot number b53031 and b40021, for sterilization.Physician reported that the essure lot b40021 broke, the springs came apart.No further information was provided.It was also reported that the essure lot b53031, had two coils failed to do it's job.Reporter thinks that the pt has essure inserted in only one side.Reporter causality: the relationship between two coils-both failed to do it's job, springs came apart and pt has coil in only one side and essure was not reported.Follow-up received on 05/16/2014: information received from physician states that a (b)(6) female pt who has no previous gynecological intervention, problems nor procedures and does not have any medical history or concurrent conditions; had essure inserted on (b)(6) 2014.Pt was not post-partum at the time of insertion and no cervical dilatation or sounding were applied during insertion.Physician refers that a general anesthesia as well as analgesia with toradol were applied during procedure.Health care professional also informed that the insertion in the left side was easy; however the right side presented difficulty, physician informed that the first essure bent 90 degrees, the second one bent 180 degrees, the third one presented splintered end and the fourth one broke into three pieces.In addition a physician reported that only one side was easily visualized and states that there was also problem with hysteroscopy (prior visualization).There was no fluid loss more than 1500 cc and procedure took one and a half hours.On (b)(6) 2014, pt visited emergency room for endometritis and was treated with antibiotics (outpatient).On the same day an abdomen/pelvis computerized tomography was performed to confirm essure placement (left tube with micro-insert).There were no pathology results and no hospitalization occurred.Also according to physician, pt implored for antibiotics and pain medications.Health care professional believes that the condition was caused by essure devices and also due to difficult visualization from hysteroscopy and the devices defects.As back-up contraception after essure insertion and before total occlusion confirmation pt used condoms.No hysterosalpingogram was performed.The removal of essure devices was not performed neither is planned.

• Brand Name: ESSURE
• Type of Device: KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• Manufacturer (Section G): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• Manufacturer Contact: shaw lamberson ; 100 bayer blvd; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 3878100
• MDR Text Key: 19967077
• Report Number: 2951250-2014-00198
• Device Sequence Number: 1
• Product Code: KNH
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: B40021/B53031
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 62