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

Model Number ESS305

Device Problems Difficult to Insert (1316); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Muscle Spasm(s) (1966); Perforation (2001)

Event Date 07/13/2015

Event Type  Injury  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in (b)(6) on (b)(6) 2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted on an unspecified date.Perforation was reported and no further information was provided.Follow up received on 29-oct-2015 from gynecologist (upgraded to incident): patient's data were updated.The patient had 2 pregnancies with 2 live births by c-section.No past medical history of ectopic pregnancy, spontaneous abortion and voluntary pregnancy termination.No previous gynecological interventions.Essure insertion was performed on (b)(6) 2015 during follicular phase.Last delivery was a caesarean section.No breastfeeding at time of insertion.No abnormal uterine findings.The patient received general anesthesia.The insertion was difficult due to tubal spasms.The visualization of tubal os (orificium) was easy.Fluid loss during hysteroscopy was not more than 1500cc.The procedure did not take more than 20 min.No complaints immediately after insertion.On (b)(6) 2015 the unilateral right perforation was diagnosed via ct scan.In the left tube the essure position was correct.No organ or intra-abdominal structure perforated.The position of essure in right tube was part of the insert within the tube and another part in sigmoid.The patient had abdominal pain.No essure confirmation test done.Essure was removed by laparoscopy and the patient recovered.No pathology results, signs of infection and inflammation.No other new medical information was provided.Case closed.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and a unilateral right perforation (previously interpreted as uterine perforation and now interpreted as fallopian tube perforation) was diagnosed a week after.The position of the essure in the right tube was part within the tube and another part in sigmoid.Essure was removed by laparoscopy and the patient recovered.The fallopian tube perforation is serious due to its medical importance and listed in the reference safety information for essure.Considering the nature of this event and the complication noticed during essure insertion, the causality with essure cannot be excluded.Upon follow up, this case was regarded as incident since a device removal was required.A product technical analysis and further information are expected.

Manufacturer Narrative

Follow-up information received on 23-nov-2015 it was reported that implant was stretched and distorced, but not broken.No other new medical information will be provided.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and a unilateral right perforation (previously interpreted as uterine perforation and now interpreted as fallopian tube perforation) was diagnosed a week after.The position of the essure in the right tube was part within the tube and another part in sigmoid.Essure was removed by laparoscopy and the patient recovered.The fallopian tube perforation is serious due to its medical importance and listed in the reference safety information for essure.Considering the nature of this event and the complication noticed during essure insertion, the causality with essure cannot be excluded.Upon follow up, this case was regarded as incident since a device removal was required.Additionally, non-serious events were reported.A product technical analysis is expected.Further information will not be provided.

Manufacturer Narrative

Follow up 21-dec-2015: 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 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 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.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 23-dec-2015 for the following meddra preferred term: fallopian tube perforation.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 this meddra pt.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and a unilateral right perforation (previously interpreted as uterine perforation and now interpreted as fallopian tube perforation) was diagnosed a week after.The position of the essure in the right tube was part within the tube and another part in sigmoid.Essure was removed by laparoscopy and the patient recovered.The fallopian tube perforation is serious due to its medical importance and listed in the reference safety information for essure.Considering the nature of this event and the complication noticed during essure insertion, the causality with essure cannot be excluded.Upon follow up, this case was regarded as incident since a device removal was required.Additionally, non-serious events were reported.According to product technical analysis, there is no reason to suspect a causal relationship between the reported medical event(s) and a quality defect.Further information will not be provided.

Manufacturer Narrative

Data correction: the product code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• 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: 5239952
• MDR Text Key: 31747887
• Report Number: 2951250-2015-01612
• Device Sequence Number: 0
• Product Code: KNH
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• 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
• Date Manufacturer Received: 12/21/2015
• 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
• Patient Age: 35 YR
• Patient Weight: 60