ESSURE

Report

Report Number: 2951250-2017-01177
Event Type: Injury
Date Received: March 31, 2017
Report Date: September 29, 2017
Manufacturer: BAYER PHARMA AG
Product Code: HHS
PMA / PMN Number: P020014
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS (B)(6) YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: (B)(4)). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NOS. 838566 AND 904752) INSERTED. THE REPORT DESCRIBES A CASE OF DYSMENORRHOEA ("WORSENED CRAMPING WITH PERIOD"). CONCOMITANT PRODUCTS INCLUDED ANESTHETICS AND GENERAL ON (B)(6) 2012 FOR GENERAL ANESTHESIA AS WELL AS HYDROMORPHONE HYDROCHLORIDE (DILAUDID) ON (B)(6) 2011 AND NAPROXEN ON (B)(6) 2011. ON (B)(6) 2011, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED AND REMOVED ON AN UNKNOWN DATE. A NEW FALLOPIAN TUBE OCCLUSION INSERT WAS INSERTED ON (B)(6) 2011. IN (B)(6) 2012, THE SUBJECT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE COILS VIA BILATERAL SALPINGECTOMY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. ON (B)(6) 2017, THE DYSMENORRHOEA HAD RESOLVED. THE INVESTIGATOR CONSIDERED DYSMENORRHOEA TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INVESTIGATOR REPORTED THAT ESSURE WAS INSERTED ON LEFT SIDE ON (B)(6) 2011. PATIENT RECEIVED NAPROSYN 500MG BEFORE PROCEDURE AND INSERTION WAS DONE UNDER ORAL MEDICATIONS (DILAUDID 4MG). ONLY LEFT TUBE WAS VISUALIZED. PROCEDURE TOOK 10 MINUTES. AFTER PLACEMENT, 2 TRAILING COILS WERE VISUALIZED ON LEFT TUBE. ON (B)(6) 2012, PATIENT HAD A NEW PROCEDURE UNDER GENERAL ANESTHESIA. BOTH TUBES WERE ADEQUATE VISUALIZED. PROCEDURE TOOK 15 MINUTES. AFTER INSERTION, 2 TRAILING COILS WERE VISIBLE ON LEFT TUBE AND 5 ON RIGHT TUBE. ACCORDING TO INVESTIGATOR, THE EVENT IS NOT SERIOUS PER PROTOCOL CRITERIA, HOWEVER, IT RESULTED IN REMOVAL OF ESSURE DEVICES, NO HOSPITALIZATION REQUIRED. 3 DEVICES WERE REMOVED. 1 FROM LEFT TUBE, 1 FROM RIGHT TUBE AND 1 PARTIALLY INTRAPERITONEAL. ALL INTACT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE; ON (B)(6) 2012: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: LOT#: 838566 MANUFACTURING DATE: MAR-2011 EXPIRATION DATE: MAR-2014. LOT#: 904752 MANUFACTURING DATE: OCT-2011 EXPIRATION DATE: OCT-2014. SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCHES RECORDS AND CONFIRMED THAT FINAL PRODUCTS TESTING FOR THESE LOTS WERE PERFORMED PER REQUIREMENTS AND THE PRODUCTS MET ALL RELEASE REQUIREMENTS. WE ARE 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 WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO ME REPORTED BATCH 838566. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH 904752. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2017: STOP DATE OF EVENT ((B)(6) 2017) AND OUTCOME (RECOVERED) UPDATED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

THIS (B)(6) FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE¿ MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: (B)(6)) RECEIVED FALLOPIAN TUBE OCCLUSION INSERT. THE REPORT DESCRIBES A CASE OF DYSMENORRHOEA ("WORSENED CRAMPING WITH PERIOD"). CONCOMITANT PRODUCTS INCLUDED NAPROXEN, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) AND ANESTHETICS, GENERAL FOR GENERAL ANESTHESIA. ON (B)(6) 2011, THE SUBJECT STARTED FALLOPIAN TUBE OCCLUSION INSERT. IN (B)(6) 2012, THE SUBJECT EXPERIENCED DYSMENORRHOEA (SERIOUSNESS CRITERION CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE COILS VIA BILATERAL SALPINGECTOMY). FALLOPIAN TUBE OCCLUSION INSERT WAS WITHDRAWN. AT THE TIME OF THE REPORT, THE DYSMENORRHOEA HAD NOT RESOLVED. THE INVESTIGATOR CONSIDERED DYSMENORRHOEA TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INVESTIGATOR REPORTED THAT ESSURE WAS INSERTED ON LEFT SIDE ON (B)(6) 2011. PATIENT RECEIVED NAPROSYN 500MG BEFORE PROCEDURE AND INSERTION WAS DONE UNDER ORAL MEDICATIONS (DILAUDID 4MG). ONLY LEFT TUBE WAS VISUALIZED. PROCEDURE TOOK 10 MINUTES. AFTER PLACEMENT, 2 TRAILING COILS WERE VISUALIZED ON LEFT TUBE. ON (B)(6) 2012, PATIENT HAD A NEW PROCEDURE UNDER GENERAL ANESTHESIA. BOTH TUBES WERE ADEQUATE VISUALIZED. PROCEDURE TOOK 15 MINUTES. AFTER INSERTION, 2 TRAILING COILS WERE VISIBLE ON LEFT TUBE AND 5 ON RIGHT TUBE. ACCORDING TO INVESTIGATOR, THE EVENT IS NOT SERIOUS PER PROTOCOL CRITERIA, HOWEVER, IT RESULTED IN REMOVAL OF ESSURE DEVICES, NO HOSPITALIZATION REQUIRED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ON (B)(6) 2011: PREGNANCY TEST URINE RESULT WAS NEGATIVE. ON (B)(6) 2012: PREGNANCY TEST URINE RESULT WAS NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: LOT#: 838566, MANUFACTURING DATE: MAR-2011, EXPIRATION DATE: MAR-2014; LOT#: 904752, MANUFACTURING DATE: OCT-2011, EXPIRATION DATE: OCT-2014 . SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCHES RECORDS AND CONFIRMED THAT FINAL PRODUCTS TESTING FOR THESE LOTS WERE PERFORMED PER REQUIREMENTS AND THE PRODUCTS MET ALL RELEASE REQUIREMENTS. WE ARE 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 WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO ME REPORTED BATCH 838566. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH 904752. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: ESSURE COILS REMOVED VIA BILATERAL SALPINGECTOMY. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, STUDY CASE REPORT REFERS TO AN ADULT FEMALE SUBJECT WHO WAS INVOLVED IN AN INTERVENTIONAL COMPANY SPONSORED STUDY (STUDY NUMBER: (B)(4)). SHE HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED WORSENED CRAMPING WITH PERIOD. REMOVAL OF ESSURE WAS REQUIRED. THE INVESTIGATOR CONSIDERED THIS EVENT TO BE RELATED TO ESSURE. THIS EVENT WAS CONSIDERED AS NON-SERIOUS BY THE INVESTIGATOR AND REGARDED AS ANTICIPATED ACCORDING TO THE INVESTIGATOR'S BROCHURE FOR ESSURE. IN THIS CASE, NO ALTERNATIVE POSSIBLE EXPLANATION WAS PROVIDED. BASED ON ITS NATURE, COMPANY AGREES WITH INVESTIGATOR'S ASSESSMENT AND CONSIDERS THE EVENT AS RELATED TO ESSURE. THIS CASE WAS REGARDED AS INCIDENT BECAUSE DEVICE REMOVAL WAS REQUIRED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED, AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE, A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
233059	ESSURE	TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE	HHS	BAYER PHARMA AG	ESS305	838566, 904752

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Required Intervention	ANESTHETICS, GENERAL (B)(6) 2012\| DILAUDID (HYDROMORPHONE HYDROCHLORIDE) (B)(6) 2011\| NAPROXEN (NAPROXEN) (B)(6) 2011