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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in the united states on 28-sep-2016, which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.The patient is not pregnant.In (b)(6) 2010, the patient had essure (fallopian tube occlusion insert) inserted for sterilization.In (b)(6) 2010, hsg (hysterosalpingogram) report showed that there is no spillage.It confirmed that the essure coils were in place.On unspecified date, the hysterosalpingogram showed occlusion.She initially wanted it out.They tried all sorts of imaging to find them.Had an ablation but she did not see the coils when she went in.On unspecified date, she had a ct (computerized tomogram) done; incidentally they did not see the coils anywhere.They tried a flat plate x-ray and could not find them.They eventually removed her uterus and they weren't in the fallopian tube, neither one.Essure migrated.Her doctor mentioned the indication for use was sterilization then it got into bleeding, failed ablation.Doctor end up doing an hysterectomy.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced bleeding.An hysterectomy was performed.This event, seen as genital bleeding, is considered anticipated in the reference safety information for essure.Genital bleeding may occur with essure therapy.Based on its nature and lack of alternative explanation, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention was performed.Additionally, non-serious event was reported.Further information and product technical analysis are being sought.

Manufacturer Narrative

Quality safety evaluation received on 09-nov-2016: ptc global number (b)(4).No sample available for this investigation.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known possible undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar adverse event cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced bleeding.An hysterectomy was performed.This event, seen as genital bleeding, is considered anticipated in the reference safety information for essure.Genital bleeding may occur with essure therapy.Based on its nature and lack of alternative explanation, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention was performed.Additionally, non-serious event was reported.Product quality defect could not be confirmed but is considered plausible, a relationship with the reported medical events cannot be totally excluded.Further information is being sought.

Manufacturer Narrative

Follow-up on (b)(6) 2017: despite several attempts no follow up information (answer to questionnaire) could be obtained up to date.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced bleeding.An hysterectomy was performed.This event, seen as genital bleeding, is considered anticipated in the reference safety information for essure.Genital bleeding may occur with essure therapy.Based on its nature and lack of alternative explanation, a causal relationship with suspect insert cannot be excluded.This case was regarded as incident since a surgical intervention was performed.Additionally, non-serious event was reported.Product quality defect could not be confirmed but is considered plausible, a relationship with the reported medical events cannot be totally excluded.No further information could be obtained.

• 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: 6053897
• MDR Text Key: 58294896
• Report Number: 2951250-2016-02297
• Device Sequence Number: 1
• Product Code: HHS
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2017

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: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/29/2016; 01/24/2017
• 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