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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Component Missing (2306)

Patient Problems Abdominal Pain (1685); Perforation (2001); Foreign Body In Patient (2687)

Event Date 04/08/2014

Event Type  Injury  

Event Description

This is a spontaneous case report rec'd from a regulatory authority (case# (b)(4)) in (b)(6) on (b)(6) 2014 which refers to a (b)(6) old female patient who had essure (fallopian tube occlusion insert) inserted and experienced migration of one device in the abdominal cavity and part of the spring was missing on this explanted device.No info was given on the patient's history, past drugs, concurrent conditions or concomitant medication.On (b)(6) 2013 the patient had essure (fallopian tube occlusion insert) inserted; the lot number b26271 was provided.She presented with abdominal pain and on (b)(6) 2014, the right device was found to have migrated into the abdominal cavity (it was placed on the sigmoid opposite to the uterus - a risk of rectum perforation was reported by the surgeon).Both devices were removed, the abdominal cavity was extensively washed and a bilateral salpingectomy was performed.The surgeon noticed that there was a part of the coil missing in the explanted device.There were no clinical consequences to the patient and she had no complications postoperatively.The reporter's causality was not provided.

Manufacturer Narrative

Result and assessment of the product technical complaint investigation received on 09-may-2014: final assessment: lot history record (lhr) reviewed.Product met product release specifications.As of 04/23/2014, no device was returned; therefore, no device investigation could be completed.No conclusions can be drawn.No capa investigation is required per criteria established in wi-03635, "processing essure cases in dev@com." medical assessment: this case reported dislocation of the device to the abdominal cavity as well as breakage as part of coil was missing upon removal.These events are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No additional adverse event case reports have been received to date in relation to batch number b26271.No batch signal can be identified at this time.The review of the lot history records confirmed that the product met product release specifications.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.Follow-up information received on 03-jun-2014: patient's demographic information and medical history were provided.There was no abnormality before placement.General anesthesia, placement and visualization of ostium were easy and there was no complain immediately after placement.On (b)(6) 2014, ultrasonography and radiography were performed and showed correct placement of essure in the left tube, incorrect placement in the right side (migration to the abdominal cavity).There was no perforation.No test of essure confirmation was performed.The patient received confirmation of the efficiency of essure.On (b)(6) 2014, essure was removed laparoscopic.It was required at a medical level.The removal was done on demand from the patient.There were no signs of infection or inflammation.Report from hospital: a (b)(6) year-old female patient was wishing a definitive tubal sterilization.Technical used included: gynecological position, disinfection with betadine, clamping, realization of an urinary catheter drainage in a closed environment, performed a hysteroscopy to bettocchi finding uterine cavity of normal size and morphology with 2 ostia seen, placed springs was easy with for the two burial in the tube due to a significant bilateral tubal expansion.An indication of control hysterosalpingography within 3 months.Letter from hospital chief assistant, on (b)(6) 2013: the intervention took place without any difficulty.Followings were simple and the patient could be discharged on the same evening.Letter from physician after visit on (b)(6) 2014: control after 3 months was not performed by the patient.In front of a right inguinal pain (previously reported as abdominal pain) progressing for one month, an ultrasound assessment was performed by plain abdomen examination and showed no abnormality at the pelvis and at the inguinal cavity.But on the plain abdomen examination a migration of the right essure was found out.On clinical examination this day ((b)(6) 20 14), the abdomen was found to be flexible, vaginal touch and speculum examination were with no abnormality.The inguinal cavities were palpated and found no abnormality.There was certainly a migration of the right essure.A definitive tubal sterilization was to be performed by tubal ligation.The patient wanted the two essures to be removed.The physician explained that the left essure was certainly in the tube and that it could not be removed without a salpingectomy.The patient wanted it to be done.No further information was provided.Follow-up information received on 06-jun-2014 from the product technical complaint (ptc) group: the following information was received (ptc conclusions): the possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Based on this report the listedness of the event: there was a part of the coil missing in the explanted device was amended to listed.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• 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: 3820087
• MDR Text Key: 4451638
• Report Number: 2951250-2014-00152
• Device Sequence Number: 1
• Product Code: KNH
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: B26271
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/16/2014
• Initial Date FDA Received: 05/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 150 KG