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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Hot Flashes/Flushes (2153); Urinary Frequency (2275); Disability (2371); Sweating (2444); Abdominal Distention (2601); Weight Changes (2607); Intermenstrual Bleeding (2665); Heavier Menses (2666)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (case# mw5057188) in united states on (b)(6) 2015 who had essure (fallopian tube occlusion insert) lot number 7109955 inserted on (b)(6) 2012.After hysterosalpingogram (hsg) it was discovered one of the coils was not in the fallopian tube.Her doctor never looked or tried to locate the missing coil.She had the second coil placed in 2013.Since the coils were placed, she experienced a severely heavy period which includes large blood clots, bleeding after sex, severe bloating, weight gain, hot flashes, night sweats, and frequent urination and was admitted to the emergency room (er) for severe abdominal pain of which the cause was never determined.She was also never given a nickel allergy test before having the coils placed.Consumer assessed the event outcome as disability/permanent damage; however she did not provide further details.Follow-up information received on 02-dec-2015 from consumer: the consumer was on her 40s.She stated she was planning to have essure removed at the end of (b)(6) 2015, but had no date yet, it was not yet scheduled.The same doctor who inserted essure will do the removal.Company causality comment: this spontaneous case report received via regulatory authority refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced severe abdominal pain and one of the coils was not in the fallopian tube (understood as device dislocation).She is planning to have essure removed.Both events are serious and listed according to the essure reference safety information.Dislocation/migration may occur within essure.Due to its nature, device dislocation was considered related to essure.After essure insertion, back, pelvic and uncharacterized pain may occur.Considering this information and in the lack of an alternative explanation, a causal relationship between pelvic pain and the suspect micro-insert cannot be excluded (related).In addition non-serious events were reported.This case was initially regarded as non-incident, and upon receipt of follow-up information stating that the consumer was planning to have essure removed on the following days, the case was upgraded to incident (intervention will be required).A product technical analysis and further information are expected.

Manufacturer Narrative

Follow up 11-jan-2016: ptc investigation results were provided.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.The reported medical event(s) 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.In summary, there is no reason to suspect a causal relationship between the reported medical event(s) and a quality defect.Company causality comment: this spontaneous case report received via regulatory authority refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced severe abdominal pain and one of the coils was not in the fallopian tube (understood as device dislocation).She is planning to have essure removed.Both events are serious and listed according to essure's reference safety information.Dislocation/migration may occur within essure.Due to its nature, device dislocation was considered related to essure.After essure insertion, back, pelvic and uncharacterized pain may occur.Considering this information and in the lack of an alternative explanation, a causal relationship between pelvic pain and the suspect micro-insert cannot be excluded (related).In addition non-serious events were reported.This case was initially regarded as non-incident, and upon receipt of follow-up information stating that the consumer was planning to have essure removed on the following days, the case was upgraded to incident (intervention will be required).Based on the available information there is no reason to suspect a causal relationship between the reported medical events and a quality defect.Further information (perforation questionnaire) is expected.

Manufacturer Narrative

Follow up information received on 25-feb-2016: no further information could be obtained despite follow up attempt.Company causality comment: this spontaneous case report received via regulatory authority refers to a female consumer of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced severe abdominal pain and one of the coils was not in the fallopian tube (understood as device dislocation).She is planning to have essure removed.Both events are serious and listed according to essure's reference safety information.Dislocation/migration may occur within essure.Due to its nature, device dislocation was considered related to essure.After essure insertion, back, pelvic and uncharacterized pain may occur.Considering this information and in the lack of an alternative explanation, a causal relationship between pelvic pain and the suspect micro-insert cannot be excluded (related).In addition non-serious events were reported.This case was initially regarded as non-incident, and upon receipt of follow-up information stating that the consumer was planning to have essure removed on the following days, the case was upgraded to incident (intervention will be required).Based on the available information there is no reason to suspect a causal relationship between the reported medical events and a quality defect.Despite follow-up attempts, no further information was obtained.

Manufacturer Narrative

Data correction: the product 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: 5333105
• MDR Text Key: 34666653
• Report Number: 2951250-2015-01970
• 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: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 7109955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/08/2016; 03/22/2016; 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; Disability