HEMASHIELD PLATINUM

Additional Manufacturer Narrative

(4111) SEVERAL ATTEMPTS TO CONTACT THE AUTHOR WERE PERFORMED IN ORDER TO OBTAIN MORE INFORMATION ABOUT THE REPORTED ADVERSE EVENT. THE AUTHOR INDICATED THAT THE SURVEY DID NOT REQUEST SPECIFIC COMPLAINT INFORMATION REGARDING THE TYPE OF GRAFT USED, NOR DID IT INCLUDE QUESTIONS ADDRESSING TRENDS OR COMPLAINTS RELATED TO SPECIFIC TIME PERIODS, WHICH EXPLAINS WHY SUCH DETAILS WERE NOT PROVIDED BY THE RESPONDENT. (4112/4248) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT WHO CONCLUDED THAT: "THE EXTRACORPOREAL LIFE SUPPORT ASSOCIATION, OR ELSO, IS A NONPROFIT ORGANIZATION THAT SUPPORTS HEALTH CARE PROFESSIONALS INVOLVED IN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IN (B)(6) 2024, INTERVASCULAR SAS AND TERUMO WERE ASKED BY THE FDA¿S OFFICE OF CARDIOVASCULAR DEVICES TO PARTICIPATE IN A COLLABORATIVE EFFORT AIMED AT BETTER UNDERSTANDING THE OFF-LABEL USE OF VASCULAR GRAFTS IN EXTRACORPOREAL CIRCULATION. THIS INITIATIVE COINCIDED WITH A GLOBAL SURVEY ON AXILLARY/SUBCLAVIAN ARTERY CANNULATION USING GRAFTS FOR ECMO, INITIATED BY ELSO AND CONDUCTED BY CHRISTINE STEAD (CEO ELSO) AND DR. (B)(6). THE SURVEY WAS CARRIED OUT DURING THE FIRST QUARTER OF 2025, AND THE RESULTS WERE SHARED WITH INTERVASCULAR ON JUNE 4, 2025. THE SURVEY RECEIVED 149 RESPONSES, WITH 48% ORIGINATING FROM THE UNITED STATES. OFF-LABEL USE OF VASCULAR GRAFTS AS CONDUITS FOR ARTERIAL PERFUSION OR IMPELLA WAS REPORTED IN 95% OF U.S. RESPONSES. THE GRAFTS USED INCLUDED: HEMASHIELD, TERUMO, MEDTRONIC, GORE, ABBOT, CRYOLIFE, COOK, INTERGARD, BRAUN, LEMAITRE, CARDINAL HEALTH, BECTON DICKENSON, ENDO INTERNATIONAL, AND OTHERS. OF THE 149 PARTICIPANTS, 62 RESPONDED THE QUESTION REGARDING ADVERSE EVENTS AT THE GRAFT SITE. AMONG U.S. SURGEONS, 64.3% REPORTED EXPERIENCING AN ADVERSE EVENT. THE MOST COMMON COMPLICATION WAS BLEEDING (51%), AND 15.8% REPORTED BLEEDING-RELATED DEATH AS THE OUTCOME (BASED ON 36 RESPONSES; 113 PARTICIPANTS SKIPPED THIS QUESTION). OTHER REPORTED COMPLICATIONS INCLUDED UPPER LIMB COMPARTMENT SYNDROME, INFECTION, DISSECTION, BRACHIAL PLEXUS INJURY, THROMBOSIS, AND UPPER LIMB ISCHEMIA. THE MOST COMMON INTERVENTIONS REQUIRED WERE TRANSFUSION, ANASTOMOSIS REVISION, VASCULAR SURGERY INTERVENTION, IMPELLA REVISION/EXCHANGE, AND GRAFT REPLACEMENT. NO SPECIFIC GRAFT TYPE WAS ASSOCIATED WITH ANY PARTICULAR COMPLICATION. THE SURVEY WAS ANONYMOUS. DUE TO THE LACK OF PATIENT RECORDS, PROCEDURAL DETAILS, GRAFT SPECIFICATIONS, AND SURGEON IDENTIFIERS, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CAUSES OF THESE COMPLICATIONS. IT IS LIKELY THAT THESE EVENTS WERE ALREADY REPORTED AT THE TIME THEY OCCURRED." (24) BASED ON PROVIDED INFORMATION IN THE SURVEY NO CONCLUSION CAN BE DRAWN REGARDING THE EXACT ORIGIN OF THE EVENT. DESPITE OUR ATTEMPTS TO CONTACT THE SURVEY AUTHOR, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. FURTHERMORE, THE MEDICAL REVIEW CONCLUDED THAT, DUE TO THE LACK OF PATIENT RECORDS, PROCEDURAL DETAILS, GRAFT SPECIFICATIONS, AND SURGEON IDENTIFIERS, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN REGARDING THE CAUSES OF THESE COMPLICATIONS. IT IS LIKELY THAT THESE EVENTS WERE ALREADY REPORTED AT THE TIME THEY OCCURRED. HOWEVER, IT IS IMPORTANT TO NOTE THAT THE USE OF THE HEMASHIELD GRAFTS AND INTERGARD GRAFTS FOR EXTRACORPOREAL CIRCULATION IS CONTRAINDICATED AS MENTIONED IN THE PRODUCTS' IFUS, CONTRAINDICATIONS SECTION, HEMASHIELD OR INTERGARD / HEMAGARD VASCULAR GRAFTS ARE NOT INTENDED FOR USE AS PERFUSION BRANCH DURING EXTRACORPOREAL CIRCULATION, AS THIS MAY LEAD TO BLEEDING OR EXCESSIVE BLEEDING.

Description of Event or Problem

COMPLAINT #: (B)(4).

Additional Manufacturer Narrative

(4111/3233) ATTEMPTS TO CONTACT THE SURVEY AUTHOR TO GET MORE INFORMATION OF THE ADVERSE EVENTS REPORTED AS PART OF THE SURVEY WILL BE PERFORMED. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

A SURVEY WAS PERFORMED BY EXTRACORPOREAL LIFE SUPPORT ORGANIZATION (ELSO) REGARDING THE USE OF VASCULAR GRAFTS WITH GRAFT-FACILITATED ACCESS FOR VEINO ATERIAL-EXTRACOPOREAL MEMBRAN OXYGENATION (VA-ECMO) AND MECHANICAL CIRCULATORY SUPPORT (MCS). AS PART OF THESE TYPE OF PROCEDURES, ADVERSE EVENTS WERE REPORTED. THIS REPORT RELATES THE CASES OF DEATH MENTIONED IN THE SURVEY. BELOW IS A SUMMARY OF THE SURVEY. OBJECTIVE OF THE STUDY: THE FOCUS OF THIS SURVEY WAS ON THE USE OF SIDE GRAFTS ANASTOMOSED TO THE AXILLARY OR SUBCLAVIAN ARTERY AS PORT ACCESS FOR ARTERIAL PERFUSION IN V-A ECLS OR FOR IMPELLA OR FOR A COMBINATION OF SUCH DEVICES (REFERRED TO AS ECPELLA OR ECMELLA). EVENT DESCRIPTION: THE SURVEY DESCRIBED THAT MOST RESPONDENTS FOR BOTH GLOBALLY AND WITHIN THE US HAD EXPERIENCED AN ADVERSE EVENT AT THE GRAFT SITE. THIS REPRESENTED 53.2% GLOBALLY AND 64.3% IN THE US OF THE 62 PEOPLE WHO RESPOND TO THE QUESTIONS. GLOBALLY, 8.3% AND 15.8% IN US OF THE 36 RESPONDENTS, EXPERIENCED BLEEDING EVENTS WHICH LED TO THE DEATH OF THE PATIENT. GLOBALLY, IT REPRESENTS APPROXIMATELY 3 DEATHS. TO BE NOTED THAT DATA FROM THIS SURVEY ARE AGGREGATED DATA FROM A VOLUNTARY SURVEY, WITH NO PATIENT-INDIVIDUAL CLINICAL DATA, NO VERIFICATION OF FITTING COMPLIANCE, AND NO COMPARATIVE ANALYSIS BY PRODUCT TYPE. THERE IS NO CORRELATION BETWEEN A SPECIFIC GRAFT AND REPORTED ADVERSE EVENTS. COMPLAINT # (B)(4). THIS REPORT IS THE FIRST IN A SERIES OF 4.