INTERGARD KNITTED

Additional Manufacturer Narrative

(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 15A15. (3331/3233) THE DEVICE HISTORY RECORDS REVIEW IS ONGOING. (4115) THE DEVICE HAS BEEN DISCARDED AFTER BEING REPLACED ON (B)(6) 2019. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THIS EVENT WAS COLLECTED AS PART OF THE INTERVASCULAR PMCF REGISTRY. PATIENT (B)(6) EXPERIENCED AN INTERGARD BYPASS GRAFT INFECTION ON 16DEC2016. THE ADVERSE EVENT WAS CATEGORIZED AS MAJOR ADVERSE LIMB EVENT (MALE) AND INFECTION RELATED TO THE DEVICE. A SURGICAL PROCEDURE WAS PERFORMED WITH GRAFT REINTERVENTION BUT WITH NO AMPUTATION. THE CLINIC NOTED THAT THIS AE WAS NOT RELATED TO PROCEDURE BUT RELATIONSHIP TO THE DEVICE WAS CAUSAL. THE CLINIC PROVIDED THE FOLLOWING DETAILS, "SINCE THE LAST FEMOROTIBIAL PROSTHETIC GRAFT INFECTION, THE PATIENT HAD A CHRONIC INFECTION MANAGED WITH DOXYCYCLINE SINCE 2017. HE WAS HOSPITALIZED ON (B)(6) 2019, FOR A CLINICAL PRESENTATION OF A MARKEDLY SWOLLEN, ERYTHEMATOUS RIGHT LEG WITH PURULENT DISCHARGE AT THE ANTERIOR FEMOROTIBIAL SURGICAL SITE. DUS DEMONSTRATED A PERIPROSTHETIC COLLECTION EXTENDING ALONG THE ENTIRE FEMOROTIBIAL BYPASS GRAFT. ON (B)(6) 2019, THE PATIENT UNDERWENT REPLACEMENT OF THE RIGHT ANTERIOR PROSTHETIC FEMOROTIBIAL BYPASS WITH AN ANTERIOR FEMOROTIBIAL BYPASS USING A VENOUS ALLOGRAFT. DURING THE SAME PROCEDURE, THE INFECTED INTERGARD ILIOFEMORAL PROFUNDA BYPASS WAS ALSO REPLACED WITH AN ILIOFEMORAL PROFUNDA BYPASS USING A VENOUS ALLOGRAFT." INITIAL INDEX PROCEDURE DETAILS: ON (B)(6) 2015, A PATIENT PRESENTED WITH A LESION IN COMMON FEMORAL AND PROFUNDA FEMORAL ARTERIES OF RIGHT LOWER EXTREMITY. AN INTERGARD KNITTED VASCULAR GRAFT WAS SOAKED IN HEPARIN AND SALINE SOLUTION BEFORE THE PROCEDURE, AND THE GRAFT WAS IMPLANTED VIA FEM-FEM BYPASS WITHOUT ANY ISSUES. A CONCOMITANT PROCEDURE COMPLETED DURING GRAFT IMPLANT: RIGHT CFA AND RIGHT PFA ENDARTERECTOMY. TECHNICAL SUCCESS WAS ACHIEVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2015. COMPLAINT #(B)(4).