ESSURE

Report

Report Number: 2951250-2015-01079
Event Type: Injury
Date Received: September 24, 2015
Report Date: January 20, 2017
Manufacturer: BAYER PHARMA AG
Product Code: HHS
PMA / PMN Number: P020014
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NM, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT TECHNICAL COMPLAINT INVESTIGATION RESULT WAS UPDATED ON 31-MAR-2016: 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, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD A POSITIVE PREGNANCY TEST. PREGNANCY IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE, WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST TO DETERMINE IF THE INSERTS ARE IN THE CORRECT LOCATION AND TUBAL OCCLUSION IS PRESENT. IN THIS CASE, ABOUT 6 MONTHS AFTER ESSURE INSERTION, PATIENT UNDERWENT A HSGS (HYSTEROSALPINGOGRAM) AND THE RESULT SHOWED PERSISTENT CONTRAST VISUALIZATION LATERAL TO LEFT ESSURE DEVICE CONSISTENT WITH CONTRAST IN PERIPHERAL LEFT FALLOPIAN TUBE. ANOTHER HSG WAS PERFORMED AND CONTRAST WAS VISUALIZED LATERAL TO THE LEFT ESSURE DEVICE, SUSPICIOUS FOR CONTRAST IN THE PERIPHERAL PORTION LEFT FALLOPIAN TUBE. RIGHT FALLOPIAN TUBE OCCLUSION. PREGNANCY WAS DIAGNOSED ABOUT 1 YEAR AND 6 MONTHS AFTER ESSURE INSERTION. GIVEN A COMPATIBLE TEMPORAL RELATIONSHIP, A CAUSAL RELATIONSHIP BETWEEN PREGNANCY AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS UPGRADED TO INCIDENT, SINCE A DEVICE REMOVAL (POSTPARTUM) WAS REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. FURTHER INFORMATION (PREGNANCY OUTCOME) IS EXPECTED.

Additional Manufacturer Narrative · 1

FOLLOW-UP 29-APR-2016: FOLLOW UP LETTER WAS RETURNED UNDELIVERED. FOLLOW UP INFORMATION RECEIVED ON 04-MAY-2016: THE NURSE STATED THE REPORTER PHYSICIAN HAS NOT WORKED IN THE CLINIC OVER A YEAR. THEY COULD NOT FIND PATIENT WITH JUST INITIALS AND DATE OF BIRTH. HENCEFORTH NO FURTHER FOLLOW-UP COULD BE PURSUED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD A POSITIVE PREGNANCY TEST. PREGNANCY IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE, WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST TO DETERMINE IF THE INSERTS ARE IN THE CORRECT LOCATION AND TUBAL OCCLUSION IS PRESENT. IN THIS CASE, ABOUT 6 MONTHS AFTER ESSURE INSERTION, PATIENT UNDERWENT A HSGS (HYSTEROSALPINGOGRAM) AND THE RESULT SHOWED PERSISTENT CONTRAST VISUALIZATION LATERAL TO LEFT ESSURE DEVICE CONSISTENT WITH CONTRAST IN PERIPHERAL LEFT FALLOPIAN TUBE. ANOTHER HSG WAS PERFORMED AND CONTRAST WAS VISUALIZED LATERAL TO THE LEFT ESSURE DEVICE, SUSPICIOUS FOR CONTRAST IN THE PERIPHERAL PORTION LEFT FALLOPIAN TUBE. RIGHT FALLOPIAN TUBE OCCLUSION. PREGNANCY WAS DIAGNOSED ABOUT 1 YEAR AND 6 MONTHS AFTER ESSURE INSERTION. GIVEN A COMPATIBLE TEMPORAL RELATIONSHIP, A CAUSAL RELATIONSHIP BETWEEN PREGNANCY AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS UPGRADED TO INCIDENT, SINCE A DEVICE REMOVAL (POSTPARTUM) WAS REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS, THE REPORTED LACK OF EFFICACY AND A QUALITY DEFECT. DESPITE FOLLOW-UP ATTEMPTS, NO FURTHER INFORMATION WAS OBTAINED.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON 15-JUL-2015. IT DESCRIBES THE OCCURRENCE PREGNANCY IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2013 FOR CONTRACEPTION. ON (B)(6) 2015, THE PATIENT HAD A (B)(6) PREGNANCY TEST. ON UNSPECIFIED DATE, THE PATIENT HAD TWO HSGS (HYSTEROSALPINGOGRAM). PTC INVESTIGATION RESULT WAS RECEIVED ON 24-JUL-2015. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(4) AND PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: 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. 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: THIS PTC WAS INITIATED DUE TO A LACK OF EFFICACY. A CONTRACEPTIVE FAILURE MAY OCCUR WITH THE USE OF ANY CONTRACEPTIVE AND IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WERE AVAILABLE FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. THE REPORTED ADVERSE EVENT IS A KNOWN, POSSIBLE, UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FOLLOW-UP RECEIVED ON 02-SEP-2015: ESSURE HEALTH CARE PROVIDER PREGNANCY QUESTIONNAIRE WAS RECEIVED. INFORMATION RECEIVED FROM PHYSICIAN STATES THAT A (B)(6) FEMALE PATIENT WHO HAS AS PREVIOUS GYNECOLOGICAL INTERVENTION A CURETTAGE (DILATATION AND CURETTAGE) AND NO OTHER GYNECOLOGICAL PROBLEM OR PROCEDURE NOR ANY OTHER MEDICAL HISTORY OR CONCURRENT CONDITION AND HAS AS PREVIOUS PREGNANCIES GRAVIDA 3 AND PARA 3 (NO ABORTIONS OR ECTOPIC PREGNANCIES); HAD ESSURE (LOT NUMBER AND EXPIRATION DATE UNKNOWN) INSERTED ON (B)(6) 2013. PATIENT WAS POSTPARTUM AT THE TIME OF INSERTION. ACCORDING TO HEALTH CARE PROFESSIONAL, NO CERVICAL DILATATION, SOUNDING OR GENERAL ANESTHESIA WAS APPLIED DURING PROCEDURE. ANALGESIA WITH PERCOCET, TORADOL AND LIDOCAINE PARACERVICAL WAS DONE. PHYSICIAN CONSIDERED THE VISUALIZATION OF TUBAL OSTIUM EASY. HOWEVER, REPORTED THAT INSERTION WAS DIFFICULT AND DESCRIBED BILATERAL OSTIA WITH SCARRING VERSUS TUBAL SPASM. BOTH COILS TOOK FEW AMOUNT OF MANIPULATION (AS REPORTED). THERE WAS NO FLUID LOSS MORE THAN 1500CC DURING HYSTEROSCOPY AND THE PROCEDURE DID NOT TAKE MORE THAN 20 MINUTES. THERE WAS NO CAPABILITY FOR PICTURES AND NO IMAGING TEST WAS PERFORMED TO CONFIRM ESSURE PLACEMENT. AS BACK-UP CONTRACEPTION AFTER ESSURE INSERTION AND BEFORE TOTAL OCCLUSION CONFIRMATION PATIENT USED DEPO. ON (B)(6) 2014, HYSTEROSALPINGOGRAM WAS PERFORMED AND SHOWED PERSISTENT CONTRAST VISUALIZATION LATERAL TO LEFT ESSURE DEVICE CONSISTENT WITH CONTRAST IN PERIPHERAL LEFT FALLOPIAN TUBE. ON (B)(6) 2014 NEW HYSTEROSALPINGOGRAM WAS DONE AND CONTRAST WAS VISUALIZED LATERAL TO THE LEFT ESSURE DEVICE, SUSPICIOUS FOR CONTRAST IN THE PERIPHERAL PORTION LEFT FALLOPIAN TUBE. RIGHT FALLOPIAN TUBE OCCLUSION. ON (B)(6) 2015, PREGNANCY URINE TEST WAS DONE AND, ON (B)(6) 2015, ULTRASOUND SHOWED (B)(6) PREGNANCY AND 23 CM SUBCHORIONIC HEMORRHAGE. FIRST DATE OF LAST MENSTRUAL PERIOD IS UNKNOWN AND THE EXPECTED DELIVERY DATE IS (B)(6) 2016. CURRENTLY, THERE ARE NO COMPLICATIONS AND PATIENT PLANS TO KEEP PREGNANCY. ESSURE REMOVAL IS PLANNED TO BE PERFORMED POSTPARTUM. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HAD A POSITIVE PREGNANCY TEST. PREGNANCY IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE, WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST TO DETERMINE IF THE INSERTS ARE IN THE CORRECT LOCATION AND TUBAL OCCLUSION IS PRESENT. IN THIS CASE, ABOUT 6 MONTHS AFTER ESSURE INSERTION, PATIENT UNDERWENT A HSGS (HYSTEROSALPINGOGRAM) AND THE RESULT SHOWED PERSISTENT CONTRAST VISUALIZATION LATERAL TO LEFT ESSURE DEVICE CONSISTENT WITH CONTRAST IN PERIPHERAL LEFT FALLOPIAN TUBE. ANOTHER HSG WAS PERFORMED AND CONTRAST WAS VISUALIZED LATERAL TO THE LEFT ESSURE DEVICE, SUSPICIOUS FOR CONTRAST IN THE PERIPHERAL PORTION LEFT FALLOPIAN TUBE. RIGHT FALLOPIAN TUBE OCCLUSION. PREGNANCY WAS DIAGNOSED ABOUT 1 YEAR AND 6 MONTHS AFTER ESSURE INSERTION. GIVEN A COMPATIBLE TEMPORAL RELATIONSHIP, A CAUSAL RELATIONSHIP BETWEEN PREGNANCY AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS UPGRADED TO INCIDENT, SINCE A DEVICE REMOVAL (POSTPARTUM) WAS REQUIRED. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION (PREGNANCY OUTCOME) IS EXPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
630801	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER PHARMA AG	ESS305

Patients

Seq	Age	Sex	Outcome	Treatment
1	26 YR		Other