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

Model Number ESS205

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Pain (1994); Perforation (2001); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place in september 2015 (fda-2014-n-0736-2407, awareness date 04-nov-2015).It refers to a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in 2006.Consumer reported that one of the coils migrated out of the tube and was sitting in her peritoneal area.The other tube was occluded.Second essure was placed in the tube and also subsequently migrated and perforated her uterus.Then she had a cryoablation to stop the heavy menses.Cryo fluid leaked through the perforation / tear in her uterus and singed her small intestine.She had an emergency bowel resection within days, resecting 6 inches of matted intestine and had to stay in the hospital close to a month.She came close to a colostomy bag and experienced pain on her side certain days.Quality assessment: in this case, no product sample was returned.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.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information, there is no relationship between the reported event(s) and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report identified during monitoring of postings on an fda hosted docket website refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced heavy menses.She had a cryoablation to stop the heavy menses.It was reported that one of coils migrated out of her tube, sitting in peritoneal area.The other tube was occluded.Second essure coil subsequently migrated and perforated her uterus.These events were considered serious and listed in the reference safety information for essure.In this case, the exact date and mechanism of migration and uterine perforation were not known.Considering the nature of these events, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident due to intervention performed.Additionally, other serious events (cryo fluid leaked through the perforation/tear in my uterus, singed my small intestine and bowel resection) and non-serious events were reported.According to product technical complaint, there is no relationship between the reported event(s) and a quality defect.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

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: 5264488
• MDR Text Key: 32770728
• Report Number: 2951250-2015-01817
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• 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
• Patient Outcome(s): Other; Required Intervention