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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165); Pregnancy (3193)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age in spain on 02-oct-2015 who had essure (fallopian tube occlusion insert) inserted.This case was published in (b)(6) digital press.Pregnancy and salpingectomy were reported.After having it implanted, consumer became pregnant and had to have curettage and then a surgery to remove the tubes.One of the coils came out but the other did not.It never appeared.Company causality comment: this is a non-medically confirmed retrospective pregnancy spontaneous case report.It refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and became pregnant.She had to have curettage and surgery to remove the tubes (interpreted as salpingectomy).One of the coils came out but the other never appeared (interpreted as device dislocation).The pregnancy with device, unspecified curettage, salpingectomy and device dislocation are serious due to their medical importance.The pregnancy, salpingectomy and device dislocation are listed while the curettage is unlisted.In this particular case, limited information was provided.The elapsed time between the essure insertion and the pregnancy is not known.There are no details regarding its insertion, it was only informed that during salpingectomy one of the coils was found but the other never appeared.Although the localization of one essure coil was not known, it is not possible to exclude an essure contraceptive failure.Also, curettage for an unspecified reason was reported, due to the lack of information, it is not possible to assess this event at this time.Given the nature of a device dislocation and salpingectomy, these events are assessed as related to essure.This case is regarded as incident since a device removal was required.A product technical complaint analysis is being sought.

Manufacturer Narrative

Ptc investigation result was received on 26-jan-2016.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product 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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the reported lack of efficacy and a quality defect.The reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 27-jan-2016 for the following meddra preferred terms: salpingectomy.The analysis in the global safety database revealed (b)(4) cases.Pregnancy with contraceptive device.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Company causality comment: this is a non-medically confirmed retrospective pregnancy spontaneous case report.It refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and became pregnant.She had to have curettage and surgery to remove the tubes (interpreted as salpingectomy).One of the coils came out but the other never appeared (interpreted as device dislocation).The pregnancy with device, unspecified curettage, salpingectomy and device dislocation are serious due to their medical importance.The pregnancy, salpingectomy and device dislocation are listed while the curettage is unlisted.In this particular case, limited information was provided.The elapsed time between the essure insertion and the pregnancy is not known.There are no details regarding its insertion, it was only informed that during salpingectomy one of the coils was found but the other never appeared.Although the localization of one essure coil was not known, it is not possible to exclude an essure contraceptive failure.Also, curettage for an unspecified reason was reported, due to the lack of information, it is not possible to assess this event at this time.Given the nature of a device dislocation and salpingectomy, these events are assessed as related to essure.This case is regarded as incident since a device removal was required.Based on the available information no product quality defect was confirmed, therefore there is no reason to suspect a causal relationship between the reported medical events, the reported lack of efficacy and a quality defect.

Manufacturer Narrative

(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: 5180960
• MDR Text Key: 29402110
• Report Number: 2951250-2015-01261
• 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,foreign,other
• Type of Report: Initial,Followup,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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/23/2016; 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