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

Model Number ESS305

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problems Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a regulatory authority in (b)(6) on (b)(6)2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert).No information given on patient's history, past drugs and concurrent conditions.On (b)(6) 2014, the patient had essure (fallopian tube occlusion insert) inserted, lot number c26937.During essure placement procedure, the insertion of the spring in the left ostium went smoothly until the dropping of the spring: a part of the placement uu clamp remained with the spring.Its removal could not be done totally by hysteroscopy.A conversion by laparoscopy for ligating of the uterine tubes was then advocated per the physician.The left tube was removed without the device to be found out.A third time in hysteroscopy did not allow finding the device.The outcome of the events was unknown.The incriminated device was kept available at the pharmacy (discrepant information reported), as well as the second device not used of the same box.The criterion of seriousness was not reported.Reporter causality: the relationship between the events and essure was reported as not applicable.No further information will be available.Case closed.Company causality comment: this medically confirmed report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced a part of the uu clamp remained with the spring , complication of essure device insertion, device failed insertion, its removal could not be done totally by hysteroscopy and device was not found out.The event device was not found out is considered serious.The remaining events were considered non-serious.A part of the uu clamp remained with the spring is unlisted while the other events are listed in the reference safety information for essure.The event a part of the uu clamp remained with the spring (assumed as device breakage) was regarded as near-incident due to the reported breakage.During difficult insertion, single cases have been reported of essure breakage.In this particular case the insertion of the spring in the left ostium went smoothly until the dropping of the spring: a part of the placement uu clamp remained with the spring.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case the left tube was removed without the device to be found out.Based on the available information and due to lack of alternative explanation , causality between the evens above and essure use was considered as related.

Manufacturer Narrative

Follow-up information received on (b)(4) 2014: patient's historical condition includes: 2 vaginal deliveries, cervical spondylosis, lumbar disc herniation, scoliosis, intolerance to ibuprofen and a cholecystectomy via celioscopy.She is an active smoker with 10 cigarettes per day.Essure procedure was done under general anesthesia, rigorous asepsis and sterile surgical drape.Diagnostic hysteroscopy and try to place essure system.Insertion of speculum and prehension of cervix with pozzi forceps.Introduction of hysteroscope which allowed to see mucosa with polypoid aspect with individualized polyp in endocavitary, on left ostium area.Both ostia were seen.Essure was inserted in the right ostium with blockage and impossibility to insert completely essure.Try to place essure on the left, placement in the fallopian tube without difficulty.Release of essure: when delivery catheter was removed, a part of delivery catheter remained in place, hitched to the coil with exteriorization of the tread of delivery catheter.Decision of extraction with alligator clip which took proximal part of delivery catheter but which prompted also to a movement and deformation of the coil.Decision to switch to celioscopy, left salpingectomy and ligating of the right uterine tube after biopsy curettage of polypoid mucosa.Repeat diagnosis hysteroscopy to check the integrity of the uterine cavity.The hysteroscopy found cervico-isthmic outlet that was normal.Healthy cavity without residual essure system.No further information will be available.Case closed.Result and assessment of the product technical complaint investigation received on (b)(4) 2014: final assessment: detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: 1) rollback to initial hard stop 2) depress button 3) perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the insert's grip on the delivery wire, and potential manufacturing deficiencies.As of (b)(4) 2014, since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specifications.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.No capa investigation is required at this time per criteria established in wi 03635, "processing essure cases in dev@com," because an adequate investigation of the same failure mode has already been conducted.Conclusions: the report did not state a patient injury occurred.The possibility of a detachment difficulty event during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: the events reported are not indicative of a quality defect per se.No further ae case reports have been received to date in relation to batch no.C26937.No batch signal could be identified.In this particular case, a technical defect was reported in the context of a complicated insertion.However, the reported technical defect could not be evaluated in more detail due to lack of sample return.Furthermore a usability issue was reported.The review of the manufacturing- and release documentation of the concerned batch did not give any reason to suspect a quality deficit.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect.The reported usability issue will be subject to post market surveillance monitoring.Ptc global number is (b)(4).Correction on (b)(4) 2014: the health authority number was added as (b)(4).Correction on (b)(4) 2014 based on information from (b)(4) 2014.The following statement was added to narrative: the list of similar cases contains reports with similar events coded in meddra.It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.Bayer is closely monitoring the benefit-risk profile of essure, this includes consideration of the legacy cases in safety analyses.The cumulative review of the re-coded legacy reports has not yielded any new safety signal.Company causality comment: this medically confirmed report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced a part of the uu clamp remained with the spring (complication of essure device insertion), device failed insertion, its removal could not be done totally by hysteroscopy and device was not found out.The event device was not found out is considered serious.The remaining events were considered non-serious.A part of the uu clamp remained with the spring, (assumed as device breakage) was regarded as other reportable incident due to the reported breakage.This event previously considered unlisted according to reference safety information for essure, was, upon receipt of product technical investigation (ptc) updated to listed (anticipated), the other events are listed.During difficult insertions, single cases have been reported of essure breakage.In this particular case the insertion of the spring in the left ostium went smoothly until the dropping of the spring: a part of the placement uu clamp remained with the spring.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case the left tube was removed without the device to be found out.Based on the available information and due to lack of alternative explanation, causality between the events above and essure use was considered as related.According to ptc final assessment the technical investigation concluded "unconfirmed quality defect".Ptc medical assessment considered that based on the information available there is no reason to suspect a quality defect.The reported usability issue will be subject to post market surveillance monitoring.

Manufacturer Narrative

Follow-up received on 30-jan-2015.Product technical complaint investigation and final assessment were updated: (b)(4).Final assessment: lot number: c26937; expiration date: 28-feb-2017; production date: 19-feb-2014.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, the outer and inner coils found to be stretched.Distal tip of micro-insert was missing.We were unable to confirm any quality defect or device malfunction at this time.We also conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.Medical assessment: this ptc was initiated due to a reported product quality issue.In addition, the ae case refers to a usability issue.The batch documentation of the reported batch was reviewed.The returned complaint sample was investigated.The technical assessment concluded unconfirmed quality defect.No similar ae case reports have been received to date in relation to the reported batch.No batch signal could be identified.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.In summary, there is no reason to suspect a causal relationship to a potential quality deficit.The list of similar cases contains reports with similar events coded in meddra.It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.In this particular case a search in the database was performed on 03-feb-2015 for the following meddra preferred term: device breakage.(b)(4).Bayer is closely monitoring the benefit-risk profile of essure.This includes consideration of the legacy cases in safety analyses.The cumulative review of the reports has not yielded any new safety signal.Company causality comment: this medically confirmed report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced a part of the uu clamp remained with the spring / distal tip of micro-insert was missing (complication of essure device insertion), device failed insertion, its removal could not be done totally by hysteroscopy and device was not found out.The event device was not found out is considered serious.The remaining events were considered non-serious.A part of the uu clamp remained with the spring / distal tip of micro-insert was missing, (assumed as device breakage) is listed according to technical analysis and the other events are listed in the reference safety information for essure.During difficult insertions, single cases have been reported of essure breakage.In this particular case the insertion of the spring in the left ostium went smoothly until the dropping of the spring: a part of the placement uu clamp remained with the spring.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case the left tube was removed without the device to be found out.Based on the available information and due to lack of alternative explanation, causality between the events above and essure use was considered as related.Since device breakage (malfunction) was reported, the case is regarded as other reportable incident.After investigation of returned product (the inner and outer coil found to be stretched) the technical assessment concluded unconfirmed quality deficit.There is no reason to suspect a causal relationship to a potential quality deficit.

Manufacturer Narrative

Data correction for us reporting: the 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: 4017535
• MDR Text Key: 4847140
• Report Number: 2951250-2014-00335
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2017

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 Expiration Date: 02/28/2017
• Device Model Number: ESS305
• Device Lot Number: C26937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 08/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/17/2014; 02/25/2015; 01/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other