HEMASHIELD PLATINUM DOUBLE VELOUR

Additional Manufacturer Narrative

THE CASE HAS BEEN REVIEWED BY THE CORPORATE MEDICAL OFFICER , HIS ASSESSMENT IS BELOW: "THE EVENT DESCRIBES THE USE OF HEMASHIELD PLATINUM DOUBLE VELOUR GRAFT ANASTOMOSED TO THE AXILLARY ARTERY TO ALLOW THE INSERTION OF AN IMPELLA DEVICE. THIS USE IS CONSIDERED OFF-LABEL AS THE DEVICE HAS NOT BEEN APPROVED FOR THIS USE. THE SURGEON OBSERVED AN UNUSUAL BLEEDING FROM THE GRAFT. IT WAS RESOLVED USING TOPICAL HEMOSTATIC AGENTS. NO INFORMATION WAS PROVIDED REGARDING THE PATIENTS COAGULATION PARAMETERS AND PRE-EXISTING CONDITIONS. THE AXILLARY ARTERY IS A PARTICULARLY FRAGILE VESSEL AND BLEEDING IS NO UNUSUAL. THE BLEEDING OBSERVED THROUGH THE GRAFT COULD HAVE BEEN INFLUENCED BY THE PATIENT'S COAGULATION STATUS. NO ADDITIONAL COMMENT CAN BE MADE DUE TO LACK OF DETAILED INFORMATION REGARDING THIS EVENT." (1494) OFF LABEL USE : THIS CODE HAS BEEN ADDED IN H6 TO CODIFY THE OFF LABEL USE. (67) THE DEVICE PROBLEM CANNOT BE CONFIRMED. NO CONCLUSION CAN BE DRAWN SINCE THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. (24) PLEASE NOTE THAT, AS PER THE PRODUCT INSTRUCTIONS FOR USE, THE USE OF HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFT USED AS A CONDUIT FOR THE IMPELLA DEVICE IS NOT AN APPROVED INDICATION. INDEED, THE HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFTS ARE INDICATED FOR USE IN THE REPLACEMENT OR REPAIR OF ARTERIES AFFECTED WITH ANEURYSMAL OR OCCLUSIVE DISEASE. THE GRAFT IS ALSO RECOMMENDED FOR USE IN PATIENTS REQUIRING SYSTEMIC HEPARINIZATION PRIOR TO, OR DURING, SURGERY. (4315) THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT DUE TO LACK OF DETAILED INFORMATION REGARDING THIS EVENT. CORRECTED DATA : F11 AND F13 : IN THE INITIAL MANUFACTURER REPORT, THE BLOCKS HAVE BEEN TICKED BY ERROR. SECTION F NOT APPLICABLE TO MANUFACTURER. G4 : IN THE INITIAL MANUFACTURER REPORT THERE WAS A MISTAKE IN THE AWARE DATE DUE TO AN ERROR IN THE INITIAL COMPLAINT FORM. THE REAL AWARE DATE IS (B)(6)2019 AND NOT (B)(6)2019.

Description of Event or Problem

SEE INITIAL MFR REPORT 1640201-2019-00079. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

TRACKWISE ID # (B)(6). FOLLOW-UP REPORT WILL BE SUBMITTED ONCE NEW INFORMATION IS AVAILABLE.

Description of Event or Problem

GRAFT WAS USED IN THE AXILLARY ARTERY AS A CONDUIT FOR THE IMPELLA DEVICE. THE GRAFT HAD AN ABNORMAL AMOUNT OF LEAKAGE THROUGH THE GRAFT WHEN CLAMPED AND ALSO WHEN SEWED. HEMASTATIC AGENTS WERE THEN USED TO STOP THE BLEEDING AND THE GRAFT IS NOW WORKING SUFFICIENTLY WITH NO LEAKAGE.