HEMASHIELD PLATINUM WOVEN STRAIGHT

Description of Event or Problem

THIS EVENT WAS SUBMITTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. ON (B)(6) 2018 THE PATIENT EXPERIENCED AN ADVERSE EVENT CATEGORIZED AS INFECTION RELATED TO THE DEVICE AND PHYSICIAN DETERMINED DEVICE-RELATED AND PROCEDURE-RELATED ADVERSE EVENT. A MEDICAL TREATMENT WAS INITIATED AND THE EVENT WAS RESOLVED ON (B)(6) 2018. THE CLINIC NOTED THAT RELATIONSHIP TO PROCEDURE WAS POSSIBLE AND RELATIONSHIP TO THE DEVICE WAS "NOT RELATED". THE CLINIC PROVIDED THE FOLLOWING DETAILS, "ON (B)(6) 2018- PATIENT WAS DIAGNOSED WITH SEPSIS DUE TO METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) INFECTION; STARTED ON IV CEFAZOLIN 6G INTRAVENOUS ONCE DAILY AND DISCHARGED TO SKILLED NURSING AND INPATIENT FACILITY. THE PATIENT UNDERWENT A TAGGED WHITE BLOOD CELL TO RULE OUT INFECTION OF ENDOGRAFT THIS WAS NEGATIVE. THE PATIENT WANTED TO GO TO A SKILLED NURSING FACILITY FOR CONTINUATION OF ANTIBIOTICS. DISCHARGED (B)(6) 2018. (B)(6) 2018: THE PATIENT WAS READMITTED FROM SKILLED NURSING FACILITY TO (B)(6) HOSPITAL WITH A DIAGNOSIS OF BACTEREMIA, STILL ON INTRAVENOUS CEFAZOLIN AND NEGATIVE BLOOD CULTURES. THE PATIENT WAS DISCHARGED BACK TO SKILLED NURSING FACILITY ON INTRAVENOUS ANTIBIOTICS ON (B)(6) 2018. (B)(6) 2018: THE PATIENT WAS READMITTED TO (B)(6) HOSPITAL WITH A DIAGNOSIS OF BACTERMIA, NAUSEA AND VOMITING THOUGHT TO BE CAUSED BY INTRAVENOUS CEFAZOLIN. TRANSTHORACIC ECHOCARDIOGRAM WAS COMPLETED AND DID NOT SHOW ANY VEGETATIONS. CEFAZLOIN CONTINUED AND A WHITE BLOOD CELL SCAN COMPLETED. WHITE BLOOD CELL SCAN REVEALED WHITE BLOOD CELL LOCALIZATION ADJACENT TO THE AORTIC ARCH GRAFT. INFLAMMATION ALSO PRESENT CONSISTENT WITH INFECTION. INITIAL INDEX PROCEDURE: DETAILS: ON (B)(6) 2017, A PATIENT PRESENTED WITH AN ANEURYSM IN DESCENDING THORACIC AORTA. A HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT WAS IMPLANTED WITHOUT ANY ISSUES. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2017. COMPLAINT (B)(4).

Additional Manufacturer Narrative

(4117) BASED ON PROVIDED INFORMATION AT THE TIME OF THE EVENT THE GRAFT REMAINED IN SITU AND WAS NOT EXPLANTED. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 16A20. (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.