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

Model Number ESS305

Device Problem Malposition of Device (2616)

Patient Problem Bowel Perforation (2668)

Event Date 06/10/2014

Event Type  Injury  

Event Description

This is a spontaneous case report received from a physician in united states on (b)(6) 2014 which refers to a female pt of unspecified age who had essure (fallopian tube occlusion insert) inserted and essure had perforated her bowel.Physician stated that on (b)(6) 2014 the pt went to the med ctr and had surgery because the essure had perforated her bowel.No further info was provided.Follow up info from (b)(6) 2014: no further info was provided.Follow-up info was received on (b)(6) 2014.Ptc investigation result was received on (b)(6) 2014.The name of the physician who is taking care of the pt who had surgery performed by another doctor was provided.This adverse event report is related to a product technical complaint (ptc).The bayer ref number for the pt reports is: ptc local number (b)(4) and ptc global number (b)(4).Final assessment: since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.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 at this time.Medical assessment: the reported event is not indicative of a quality defect per se.No batch number was reported.Without this info neither the technical batch evaluation nor a batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no suspicion of a quality defect based on this report.

Manufacturer Narrative

F/u info was received on 7/15/2014 via uterine / tuna.Perforation questionnaire.Pt's initial and date of birth was provided.This report refers to a (b)(6) female pt.The pt did not have any previous gynecological interventions, gynecological problem or procedures.She denied any relevant medical history or concurrent conditions.She had 02 pregnancies, and 02 live births.She was non-pregnant.On (b)(6) 2014 essure was easily implanted under general anesthesia.The visualization of the "tuouostium" was easy.Fluid loss during hysterectomy was less than 1500cc and the procedure did not take more than 20 mins.The uterus is anteverted, globally normal in echotexture and size.The ovaries were normal in echogenicity and size."dem proverd" was used as backup contraception.The pt experienced pelvic pain and vomiting.On (b)(6) 2014 an ultrasound and x-ray were performed and showed essure devices in the pelvis, one near medline, and one to the right of medline, not tubal ligation clips as provided in the history for the ultrasound exam.Partial perforation on the right was reported.Bowel-t "ilium" was perforated.The perforation occurred after deployment.On (b)(6) 2014 she underwent a bowel resection.Essure removal was medically necessary due to pain.Laparoscopy was used for essure removal.Salpingectomy was necessary.A partial bowel resection was performed due to a through and through perforation from an essure device (pt had a perforation through essentially the fundus of the uterus; the perforation went into the small bowel).Patients symptoms resolved after surgery.No further information was provided.Company causality comment: this medically confirmed, spontaneous case report, refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced partial perforation right and essure devices in pelvis, had perforated her bowel and had surgery.The reported events were considered serious due to medical importance and are listed according to reference safety information for essure.The perforation of the uterus, fallopian tubes and internal bodily structures may occur during essure therapy due to insert migration or during insertion procedure (hysteroscopy or essure placement).Owing to the anatomical relationship between bowel and uterus, the bowel is the most commonly affected organ.In this particular case, the patient developed pelvic pain and vomiting, and during investigation it was discovered that she had partial uterine perforation on right and this perforation went into the small bowel (essure devices in pelvis, had perforated her bowel).She was treated surgically.Considering these events pathophysiology and the positive temporal relationship they were considered as related to essure therapy and regarded as incidents due to the reported surgery.A product technical complaint (ptc) analysis was performed and concluded that there is no suspicion of a quality defect based on this report.No further information is expected.

Manufacturer Narrative

Follow-up 24-mar-2015: this case was published.Citation: riley k, beltran f, stewart d, harkins g."bowel perforation after placement of tubal occlusion contraceptive".Obstetrics & gynecology 2015: 125 (4); pp: 860-862.Previously reported information is re-stated.Additionally, from the publication: within 2 days of placement, she had right-sided pelvic pain, nausea, and constipation.Her symptoms worsened, and she presented to her physician for evaluation approximately 2 weeks after her procedure and underwent imaging.A flat plate radiograph showed malposition of the tubal occlusion contraceptive within the myometrium and in the pelvis near the midline.At the time of laparoscopy, perforation of the tubal occlusion contraceptive through the fundus of the uterus was noted.The perforation went into the small bowel and completely through to the mesenteric aspect.The fallopian tubes were removed.Because of a through-and-through bowel perforation, colorectal surgery was consulted intraoperatively.Bowel perforation at the terminal ileum on both the medial and the inferior lateral walls extending into the root of the mesentery within 4 cm of the ileocecal valve was identified.As a result of the location of the bowel perforation, laparoscopic ileocolectomy with construction of a stapled, functional end-to-end ileocolic anastomosis was performed.The patient did well and was discharged to home on postoperative day 3.She was seen for follow-up 3 weeks after surgery and reported normal bowel function.Authors comment: although a common adverse effect of tubal occlusion contraceptive placement, patients reporting persistent pain should prompt the possibility of malposition and perforation.Although rare, bowel perforation after placement of the tubal occlusion contraceptive can occur.There should be a low threshold for evaluation of complications after tubal occlusion contraceptive.Morbidity to this patient was minimized as a result of the timeliness of diagnosis and the availability of a skilled laparoscopic colorectal consultant surgeon.Company causality comment: this medically confirmed, spontaneous case report, refers to female patient who had essure (fallopian tube occlusion insert) inserted and experienced perforation of the tubal occlusion contraceptive through the fundus of the uterus (previously reported as partial perforation right) and essure devices in pelvis, had perforated her bowel and had surgery.The reported events were considered serious due to medical importance and are listed according to reference safety information for essure.The perforation of the uterus, fallopian tubes and internal bodily structures may occur during essure therapy due to insert migration or during insertion procedure (hysteroscopy or essure placement).Owing to the anatomical relationship between bowel and uterus, the bowel is the most commonly affected organ.In this particular case, the patient developed pelvic pain and vomiting, and during investigation it was discovered that she had perforation of the tubal occlusion contraceptive through the fundus of the uterus and this perforation went into the small bowel (essure devices in pelvis, had perforated her bowel).She was treated surgically.Considering these events pathophysiology and the positive temporal relationship they were considered as related to essure therapy and regarded as incidents due to the reported surgery.A product technical complaint (ptc) analysis was performed and concluded that there is no suspicion of a quality defect based on this report.No further information is expected.

• Brand Name: ESSURE
• Type of Device: 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: k. shaw lamberson ; 100 bayer blvd., p.o. box 915; po box 915; whippany, NJ 07981-0915
• MDR Report Key: 3955147
• MDR Text Key: 4628382
• Report Number: 2951250-2014-00268
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female