ESSURE

Report

Report Number: 2951250-2016-02166
Event Type: Malfunction
Date Received: October 11, 2016
Report Date: November 16, 2016
Manufacturer: BAYER HEALTHCARE LLC
Product Code: HHS
PMA / PMN Number: P020014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FOLLOW-UP WAS RECEIVED ON (B)(6) 2016 WITH NO NEW CLINICAL INFORMATION. FOLLOW UP INFORMATION (BREAKAGE QUESTIONNAIRE) RECEIVED ON (B)(6) 2016: ESSURE LOT NUMBER C51344 WAS INSERTED. DEVICE BREAKAGE WAS DIAGNOSED AT PROCEDURE. THE CATHETER BROKE - KNOB/TIP OF CATHETER, THE BREAKAGE OCCURRED AT THE INNER COIL - METAL KNOB AT THE INNER SIDE. INITIALLY THE PHYSICIAN COULD NOT DEPLOY THE DEVICE, AFTER THE DEPLOYING PASSED SECOND TIME THEN DEPLOYED BUT THE METAL KNOB STAYED INSIDE WHICH NEEDED TO BE REMOVED. IT WAS MEDICALLY NECESSARY TO REMOVE ESSURE. REMOVAL METHOD: HYSTEROSCOPY. THE BROKEN PIECES WERE RETRIEVED FROM THE UTERUS AND THERE WAS NO PATIENT INJURY. AT THE REPORTING TIME, THE PATIENT RECOVERED. QUALITY SAFETY EVALUATION RECEIVED ON 07-NOV-2016: (B)(4). LOT NUMBER C35396, MANUFACTURING DATE 18-MAR-2014, EXPIRATION DATE 31-MAR-2017. LOT NUMBER C51344, MANUFACTURING DATE 06-MAY-2014, EXPIRATION DATE 31-MAY-2017. DEPLOYMENT DIFFICULTY IS DEFINED AS A FAILURE OF THE MICRO-INSERT OUTER COILS TO EXPAND FROM THE WOUND DOWN POSITION. PER THE INSTRUCTIONS FOR USE (IFU), THE PHYSICIAN MUST PERFORM THE FOLLOWING STEPS IN ORDER TO ACHIEVE PROPER DEPLOYMENT: ROLLBACK TO INITIAL HARD STOP. DEPRESS BUTTON. PERFORM FINAL ROLLBACK. UNDER NORMAL CIRCUMSTANCES, WHEN THE PHYSICIAN COMPLETES THE PROPER ESSURE PLACEMENT STEPS, THE RELEASE RIBBON SHOULD DISENGAGE FROM THE PLATINUM HALF BAND (WELDED ONTO OUTER COILS OF MICRO-INSERT). ONCE DISENGAGEMENT OCCURS, THE OUTER COILS SHOULD EXPAND. IF IT DOES NOT, THIS IS REFERRED TO DEPLOYMENT DIFFICULTY. SINCE PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE ABLE TO CONDUCT AN INVESTIGATION OF THE ACTUAL DEVICES INVOLVED IN THIS COMPLAINT. SYSTEM 1: VISUAL INSPECTION WAS PERFORMED AND IT WAS CONFIRMED THAT ALL COMPONENTS ARE PRESENT, ALL IFU STEPS WERE COMPLETED (SYSTI-PICI). NO DAMAGES WERE OBSERVED ON THE DELIVERY CATHETER (SYSTI-PIC2). SYSTEM 2: LT WAS CONFIRMED THAT ALL COMPONENTS ARE PRESENT, ALL IFU STEPS WERE COMPLETED (SYST2-PICL). NO DAMAGES WERE OBSERVED ON THE DELIVERY CATHETER (SYST2-PIC2). SYSTEM 3: LT WAS CONFIRMED THAT ALL COMPONENTS ARE PRESENT, ALL IFU STEPS WERE COMPLETED (SYST3-PICL ). NO DAMAGES WERE OBSERVED ON THE DELIVERY CATHETER (SYST3-PIC2). SYSTEM 4: LT WAS CONFIRMED THAT ALL COMPONENTS ARE PRESENT: IFU STEPS WERE NOT COMPLETED (FINAL ROLLBACK).(SYST4-PICI). NO DAMAGES WERE OBSERVED ON THE DELIVERY CATHETER (SYST4-PIC2). SYSTEM 5: LT WAS CONFIRMED THAT ALL COMPONENTS ARE PRESENT, ALL IFU STEPS WERE COMPLETED (SYST5-PICL ). NO DAMAGES WERE OBSERVED ON THE DELIVERY CATHETER (SYST5-PIC2). FOR THE FIVE DEVICES. IN REGARDS OF VISUAL INSPECTION OF DELIVERY WIRE HOLDER BOND, HYPO-TUBE TO HANDLE BOND AND THE PTFE LINER AREA WERE IN CONFORMANCE WITH ACCEPTANCE CRITERIA PER INSPECTION PROCESS ALSO FOR THE DIMENSIONAL INSPECTION THE LENGTH OF THE INNER CATHETER WERE IN COMPLIANCE WITH ACCEPTANCE CRITERIA AS PER INSPECTION PROCESS. ADDITIONALLY WE RECEIVED 3 IMPLANTS MIXED DUE TO THAT, WE CAN'T DETERMINE TO WHICH DEVICE CORRESPOND EACH IMPLANT. IMPLANT 1 WAS FOUND IN PERFECT CONDITIONS BUT FOR THE IMPLANTS 2 AND 3 DAMAGES WERE OBSERVED ON THE OUTER COIL AND INNER COIL (STUCK ITSELF AND BENT). WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. FOR THIS CASE BOTH LOT NUMBERS WERE ANALYZED. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORDS AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THESE LOTS WERE PERFORMED PER REQUIREMENTS AND THE PRODUCTS MEET ALL RELEASE REQUIREMENTS. THE POSSIBILITY OF A DEPLOYMENT DIFFICULTY EVENT IS AN ANTICIPATED EVENT AND THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE CURRENT DFMEA WAS REVIEWED FOR THIS FAILURE MODE TO CONFIRM THAT ADEQUATE RISK MITIGATION ACTIONS WERE TAKEN TO MINIMIZE THE RESIDUAL RISK. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE DAMAGE AND DEVICE DEPLOYMENT ISSUE. SINCE NO MEDICAL EVENTS WERE REPORTED AT THIS POINT IN TIME, THE ASSESSMENT OF A RELATIONSHIP WITH A QUALITY DEFECT, AS WELL AS, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR ADVERSE EVENT CASES ARE NOT APPLICABLE. THE LIST OF DEVICE SIMILAR INCIDENTS 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 (B)(6) 2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE DAMAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 02 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 MEDICALLY CONFIRMED SPONTANEOUS CASE REFERS TO A FEMALE PATIENT WHO HAD AN ATTEMPT TO HAVE ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER DEPLOYING, THE MICRO INSERT DETACHED BUT DID NOT EXPAND IN FALLOPIAN TUBE OR GOT BROKEN AFTER DEPLOYMENT. THIS HAPPENED ON 3 OCCASIONS FROM THE SAME BATCH NUMBER AND SAME PATIENT. IT WAS REPORTED THAT THE BREAKAGE OCCURRED AT THE INNER COIL - METAL KNOB AT THE INNER SIDE. INITIALLY THE PHYSICIAN COULD NOT DEPLOY THE DEVICE, AFTER THE DEPLOYING PASSED SECOND TIME THEN DEPLOYED BUT THE METAL KNOB STAYED INSIDE WHICH NEEDED TO BE REMOVED. MICRO INSERTS HAVE BEEN RETRIEVED BY HYSTEROSCOPY. NO PATIENT INJURY OCCURRED. HOWEVER, UPON RECEIPT OF PRODUCT TECHNICAL COMPLAINT, THE REPORTED DEVICE BREAKAGE COULD NOT BE CONFIRMED AND DAMAGES WERE OBSERVED IN ONLY 2 IMPLANTS (ONE IN PERFECT CONDITION). THE DELIVERY CATHETER (5 RETURNED SAMPLES) AND DELIVERY WIRE HOLDER BOND (5 RETURNED SAMPLES) WERE ALL IN CONFORMANCE WITH ACCEPTANCE CRITERIA. THEREFORE, THE REPORTED EVENT WAS NOT REGARDED AS DEVICE BREAKAGE. DEVICE DAMAGE IS REGARDED AS UNANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, CONSIDERING THAT THIS DAMAGE OCCURRED DURING INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE INSERTION CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE DAMAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, IT MIGHT HAVE LED TO IT UNDER LESS FORTUNATE CIRCUMSTANCES. BASED ON THE AVAILABLE INFORMATION, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN (B)(6) ON 13-SEP-2016 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT TO HAVE ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2016. IT WAS REPORTED THAT AFTER DEPLOYING, THE MICRO INSERT DETACHED BUT DID NOT EXPAND IN FALLOPIAN TUBE OR GOT BROKEN AFTER DEPLOYMENT; THIS HAPPENED ON 3 OCCASIONS FROM THE SAME BATCH NUMBER AND SAME PATIENT. MICRO INSERTS HAVE BEEN RETRIEVED. FOLLOW-UP RECEIVED ON 15-SEP-2016: LOT NUMBER WAS C35396. FOLLOW UP INFORMATION RECEIVED ON 19-SEP-2016: THE HEALTH AUTHORITY REFERENCE NUMBER FOR THIS CASE IS: (B)(4). COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REFERS TO A FEMALE PATIENT WHO HAD AN ATTEMPT TO HAVE ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND AFTER DEPLOYING, THE MICRO INSERT DETACHED BUT DID NOT EXPAND IN FALLOPIAN TUBE OR GOT BROKEN AFTER DEPLOYMENT. THIS HAPPENED ON 3 OCCASIONS FROM THE SAME BATCH NUMBER AND SAME PATIENT. MICRO INSERTS HAVE BEEN RETRIEVED. DEVICE BREAKAGE DURING INSERTION IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, IT IS NOT CLEAR IF IN ALL 3 OCCASIONS, BOTH DEPLOYMENT ISSUE AND BREAKAGE OCCURRED OR IF THEY OCCURRED IN SOME OF THESE OCCASIONS. ANYWAY, CONSIDERING THAT THIS BREAKAGE OCCURRED DURING INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE INSERTION CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, IT MIGHT HAVE LED TO IT UNDER LESS FORTUNATE CIRCUMSTANCES. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
670594	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER HEALTHCARE LLC	ESS305	C51344

Patients

Seq	Age	Sex	Outcome	Treatment
1