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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

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BAYER PHARMA AG ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Event Type  Injury  
Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who received essure for sterilization. The occurrence of additional non-serious events is detailed below. On (b)(6) 2014, the patient started essure. On an unknown date, the patient experienced device dislocation (serious criteria medically significant and clinically significant/intervention required), device breakage (serious criterion medically significant), pelvic pain ("pain"), abdominal distension ("bloating"), headache ("headaches"), anxiety ("anxiety") and depression ("depression"). The patient was treated with surgery (hysterectomy performed on (b)(6) 2015). Essure was withdrawn. At the time of the report, the device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety and depression outcome was unknown. The reporter considered device dislocation, device breakage, pelvic pain, abdominal distension, headache, anxiety and depression to be related to essure. Company causality comment: this non-medically confirmed spontaneous legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted. She had migration of implant (seen as device dislocation) and fracturing of the implant (seen as device breakage). A hysterectomy was performed to remove micro-inserts around 1 year and half after insertion. Both events are serious due to medical significance and anticipated in the reference safety information for essure. During essure therapy there is a risk that the device could move out of fallopian tubes; this movement could be a dislocation/ migration, or occur as a result of uterine perforation. In the present case, consumer presented migration of implant followed by surgical removal of device. Given the nature of event, a causal relationship with essure cannot be excluded. Regarding event device breakage, during difficult insertions and removals, single cases have been reported of essure breakage, in this case the mechanism of the device breakage is unknown. Given event's nature causality cannot be excluded this case was regarded as incident since device removal was required. A product technical analysis is being sought. Further information will be obtained through the litigation process.

 
Manufacturer Narrative

(b)(4). Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record. We were 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 is the possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device. Based on the provided information the defect type corresponds to the following meddra llt: device breakage. 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 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. Most recent follow-up information incorporated above includes: on 6-jan-2017: ptc investigation result. Company causality comment: this non-medically confirmed spontaneous legal case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted. She had migration of implant (seen as device dislocation) and fracturing of the implant (seen as device breakage). A hysterectomy was performed to remove micro-inserts around 1 year and half after insertion. Both events are serious due to medical significance and anticipated in the reference safety information for essure. During essure therapy there is a risk that the device could move out of fallopian tubes; this movement could be a dislocation/ migration, or occur as a result of uterine perforation. In the present case, consumer presented migration of implant followed by surgical removal of device. Given the nature of event, a causal relationship with essure cannot be excluded. Regarding event device breakage, during difficult insertions and removals, single cases have been reported of essure breakage, in this case the mechanism of the device breakage is unknown. Given event's nature causality cannot be excluded this case was regarded as incident since device removal was required. According to the product technical analysis, product quality defect could not be confirmed but is considered plausible. Further information will be obtained through the litigation process.

 
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Brand NameESSURE
Type of DeviceTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
Manufacturer (Section D)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM  13353
Manufacturer (Section G)
BAYER PHARMA AG
müllerstr. 178
berlin, 13353
GM  13353
Manufacturer Contact
k shaw lamberson
100 bayer blvd, p.o. box 915
whippany , NJ 07981-0915
MDR Report Key6215742
Report Number2951250-2016-02854
Device Sequence Number1
Product CodeHHS
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberESS305
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/14/2017
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 TREATMENT DATA
Date Received: 12/30/2016 Patient Sequence Number: 1
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