ESSURE

Report

Report Number: 2951250-2015-00372
Event Type: Injury
Date Received: June 5, 2015
Date of Event: January 23, 2015
Report Date: January 19, 2017
Manufacturer: BAYER PHARMA AG
Product Code: HHS
PMA / PMN Number: P020014
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

FOLLOW UP 08-JUN-2015: FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN (HCP QUESTIONNAIRE). PATIENT WAS NOT POST-PARTUM AT TIME OF ESSURE INSERTION. SOUNDING WAS PERFORMED DURING PROCEDURE. THE INSERTION AND VISUALIZATION OF TUBAL OSTIUM WAS EASY. NO FLUID LOSS MORE THAN 1500CC AND THE PROCEDURE DID NOT TAKE MORE THAN 20 MINUTES. IMAGING TEST (UNSPECIFIED) WAS PERFORMED TO CONFIRM ESSURE PLACEMENT BUT HYSTEROSALPINGOGRAM WAS NOT DONE. DIAGNOSTIC TESTS OR PATHOLOGY RESULTS WERE NOT PERFORMED. HOSPITALIZATION DID NOT OCCUR. THE LEFT ESSURE WAS REMOVED VIA HYSTEROSCOPY. HYSTERECTOMY OR SALPINGECTOMY WAS NOT NECESSARY. DURING SURGERY IT WAS FOUND THAT THE LEFT SIDE WAS MOSTLY IN THE UTERINE CAVITY AND THE LEFT TUBAL OSTIUM WAS SCARRED. PHYSICIAN ALSO REPORTED THAT PATIENT WAS WELL AND TOLERATED THE PROCEDURE WELL. SHE WANTED TO RETURN FOR BILATERAL TUBAL LIGATION IN FUTURE AND WAS GIVEN ORAL CONTRACEPTIVES. COMPANY CAUSALITY COMMENT: THIS IS A MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT. IT REFERS TO A (B)(6) FEMALE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND LEFT ESSURE DID NOT PASS THROUGH THE TUBE TO ITS NORMAL LENGTH. LONG PART REMAINED OUTSIDE OF THE TUBE, MOSTLY IN THE UTERINE CAVITY. APPROXIMATELY TWO WEEKS LATER, ESSURE WAS REMOVED VIA HYSTEROSCOPY. ESSURE DID NOT PASS THROUGH THE TUBE TO ITS NORMAL LENGTH, INTERPRETED AS DEVICE DEPLOYMENT ISSUE, IS CONSIDERED SERIOUS DUE TO REQUIRED INTERVENTION. ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION, THIS EVENT IS LISTED. DURING DIFFICULT INSERTIONS, ESSURE PLACEMENT MAY BE UNSUCCESSFUL. CONSIDERING THAT IT OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. ADDITIONAL NON-SERIOUS EVENT WAS REPORTED. THIS CASE IS REGARDED AS INCIDENT DUE TO REQUIRED INTERVENTION. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT.

Additional Manufacturer Narrative · 1

DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

Description of Event or Problem · 1

THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON 11-MAY-2015 WHICH REFERS TO A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2015 (LOT NUMBER C18716). PHYSICIAN REPORTED THAT LEFT ESSURE DID NOT PASS THROUGH THE TUBE TO ITS NORMAL LENGTH. LONG PART REMAINED OUTSIDE OF THE TUBE. ON (B)(6) 2015 THE LEFT ESSURE WAS REMOVED AND PATIENT OPTED FOR TUBAL LIGATION IN THE OPERATING ROOM. NO INJURY. RIGHT TUBE DEVICE WAS PLACED. PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON 22-MAY-2015: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT AND WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. IN ADDITION, THE AE CASE REFERS TO A USABILITY ISSUE. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). FINAL ASSESSMENT: LOT NUMBER: C18716; PRODUCTION DATE: 04-FEB-2014; EXPIRATION DATE: 28-FEB-2017. 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 TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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 NEW FAILURE MODE HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. IN ADDITION, THE AE CASE REFERS TO A USABILITY ISSUE. HOWEVER, NO ADVERSE EVENTS HAVE BEEN REPORTED. SINCE NO ADVERSE EVENTS HAVE BEEN REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS IS A MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT. IT REFERS TO A (B)(6)-YEAR-OLD FEMALE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND LEFT ESSURE DID NOT PASS THROUGH THE TUBE TO ITS NORMAL LENGTH. LONG PART REMAINED OUTSIDE OF THE TUBE. APPROXIMATELY TWO WEEKS LATER, ESSURE WAS REMOVED AND PATIENT OPTED FOR TUBAL LIGATION IN THE OPERATING ROOM. NO INJURY. RIGHT TUBE DEVICE WAS LEFT IN PLACE. ESSURE DID NOT PASS THROUGH THE TUBE TO ITS NORMAL LENGTH, INTERPRETED AS DEVICE DEPLOYMENT ISSUE, IS CONSIDERED SERIOUS DUE TO REQUIRED INTERVENTION. ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION, THIS EVENT IS LISTED. DURING DIFFICULT INSERTIONS, ESSURE PLACEMENT MAY BE UNSUCCESSFUL. CONSIDERING THAT IT OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS INCIDENT DUE TO REQUIRED INTERVENTION. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION IS BEING SOUGHT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
364469	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER PHARMA AG	ESS305	C18716

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Other\| R