HEMASHIELD

Additional Manufacturer Narrative

THE PRODUCT WAS MOST LIKELY IMPLANTED IN 2017 , BECAUSE THE ARTICLE (FIRST PUBLISHED ON (B)(6)2020) INDICATES "UNTIL NOW, THE PATIENT HAS BEEN FOLLOWED FOR 36 MONTHS WITH ANNUAL CTA IMAGING AND SHE HAS BEEN SYMPTOM- AND INFECTION-FREE". THIS LETS US THINK THAT THE DEVICE WAS IMPLANTED IN 2017. HOWEVER, THE EXACT DAY AND MONTH ARE UNKNOWN. FOR THAT REASON, WE HAVE DELIBERATELY SET A DATE OF (B)(6)2017.ADDITIONAL MFG NARRATIVE:(4111/3221) THREE ATTEMPTS TO CONTACT THE AUTHORS IN ORDER TO OBTAIN MORE INFORMATION ON THE EVENT AND THE INVOLVED PRODUCT WERE MADE. THE ANSWER OBTAINED IS AS FOLLOWS:"[...]WE DO NOT HAVE AVAILABLE DATA RELATED TO THE EFFECT OF THE HEMASHIELD GRAFT ON THE INFECTION EVENT IN OUR PATIENT. ON THE OTHER HAND, OUR PATIENT IS IN GOOD CONDITION AND THERE IS NO PROBLEM WITH THE AORTIC GRAFT FOR NOW."THE CASE WAS FURTHER REVIEWED BY THE CORPORATE MEDICAL OFFICER. HIS ASSESSMENT IS AS FOLLOWS:"I REVIEWED THE ARTICLE PUBLISHED BY DR.(B)(6) AND COLLEAGUES REGARDING A CASE OF POST-OPERATIVE MEDIASTINAL INFECTION FOLLOWING AN EMERGENT SURGERY TO CORRECT AN AORTIC DISSECTION TYPE A. THE MICROORGANISM INVOLVED IN THE INFECTION WERE ISOLATED: STREPCOCOCCUS VIRIDANS AND STAPHYLOCOCCUS EPIDERMIDIS. BOTH BACTERIA ARE NORMALLY PRESENT IN HUMANS IN THE ORAL CAVITY, UPPER RESPIRATORY, DIGESTIVE TRACT AND SKIN SURFACE. IT APPEARS A CONTAMINATION OF THE MEDIASTINAL CAVITY OCCURRED DURING THE OPERATION. WE CANNOT SPECULATE ON CAUSES AND SPECIFIC DETAILS OF HOW IT OCCURRED. THE COMPLICATION DESCRIBED IS A KNOWN COMPLICATION FOR THIS TYPE OF SURGERY AND ESPECIALLY IN EMERGENT SURGERIES. THERE IS NO INDICATION THE GRAFT USED PLAYS ANY ROLE IN THE DEVELOPMENT OF THE INFECTION."BASED ON CURRENT INFORMATION, INVESTIGATION CONCLUSION IS AS FOLLOWS:(22) THE REPORTED ADVERSE EVENT IS KNOWN AND DOCUMENTED IN THE LABELING. INDEED, THIS COMPLICATION (INFECTION) IS MENTIONED IN OUR RISK MANAGEMENT DOCUMENTATION. MOREOVER, BASED ON THE FOLLOWING PART OF THE ASSESSMENT OF THE CORPORATE MEDICAL OFFICER "THE COMPLICATION DESCRIBED IS A KNOWN COMPLICATION FOR THIS TYPE OF SURGERY AND ESPECIALLY IN EMERGENT SURGERIES. ", WE CAN CONCLUDE THAT THIS EVENT IS A WELL-KNOWN RISK ASSOCIATED WITH THE USE OF VASCULAR GRAFTS. IN ADDITION, THIS COMPLICATION IS MENTIONED IN THE CURRENT VERSION OF THE PRODUCT INSTRUCTIONS FOR USE: ¿POTENTIAL COMPLICATIONS WHICH MAY OCCUR IN CONJUNCTION WITH THE USE OF ANY VASCULAR PROSTHESIS INCLUDE THROMBOSIS, EMBOLIC EVENTS, OCCLUSION AND STENOSIS, INTIMAL HYPERPLASIA WHICH COULD CAUSE RECURRENT SYMPTOMS, INFECTION, SEPSIS, PERIGRAFT FLUID, SEROMA FORMATION, BLEEDING, HEMATOMA, FEVER, INFLAMMATORY REACTION, PSEUDOANEURYSM, ANASTOMOTIC ANEURYSM, STROKE, DILATATION OF THE PROSTHESIS, ANASTOMOTIC DISRUPTION OR TEARING OF THE SUTURE LINE AND/OR HOST VESSEL¿.(67) THE CONDUCTED INVESTIGATION SUGGESTS THAT THE PRODUCT WAS NOT DEFECTIVE.

Description of Event or Problem

COMPLAINT #(B)(4).

Additional Manufacturer Narrative

THE PRODUCT WAS MOST LIKELY IMPLANTED IN 2020, HOWEVER THE EXACT DAY AND MONTH ARE UNKNOWN. FOR THAT REASON, WE HAVE DELIBERATELY SET A DATE OF JANUARY 1, 2020. DEVICE IS NOT ACCESSIBLE AS IT REMAINED IMPLANTED IN THE PATIENT. OCCURRENCE OF INFECTIONS WITH HEMASHIELD GRAFTS IS THOROUGHLY MONITORED AND REVIEWED DURING MONTHLY QUALITY MEETING. SO FAR, THESE TYPES OF ADVERSE EFFECTS AND THEIR INCIDENCE ARE CONSISTENT WITH WHAT IS ANTICIPATED IN THE PRODUCT RISK ASSESSMENT. WE WILL CONTINUE TO MONITOR THESE EVENTS IN ACCORDANCE WITH OUR PROCEDURES. AN ATTEMPT TO CONTACT THE AUTHOR IN ORDER TO OBTAIN MORE INFORMATION ON THE EVENT AND THE INVOLVED PRODUCT WAS MADE. RESULTS ARE PENDING. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THIS IS A CASE REPORT FROM LITERATURE OF A (B)(6) YEAR-OLD FEMALE WITH MEDIASTINITIS AND GRAFT INFECTION AFTER TYPE A AORTIC DISSECTION, OPERATION PERFORMED IN EMERGENCY. THE ABSTRACT OF THE ARTICLE IS AS FOLLOWS: "BACKGROUND. POSTOPERATIVE THORACIC AORTIC GRAFT INFECTION (TAGI) IS A SERIOUS AND POTENTIALLY FATAL COMPLICATION. THE CLASSICAL APPROACH IS TO REPLACE THE INFECTED GRAFT. HOWEVER, THIS APPROACH HAS A HIGH MORTALITY RATE. ALTERNATIVELY, TREATMENT OF TAGI WITHOUT GRAFT REPLACEMENT CAN BE PERFORMED. METHOD. HEREIN, WE PRESENT A (B)(6) YEAR-OLD CASE WITH MEDIASTINITIS AND GRAFT INFECTION AFTER TYPE A AORTIC DISSECTION OPERATION AND SUCCESSFUL TREATMENT USING OMENTAL FLAP COVERAGE FOLLOWING VACUUM-ASSISTED WOUND CLOSURE THERAPY WITHOUT GRAFT REPLACEMENT. CONCLUSION. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE COURSE AND REMAINS INFECTION-FREE TO DATE". AS STATED IN THE ARTICLE: "THE PATIENT UNDERWENT EMERGENT SURGERY. THE ASCENDING AORTA AND HEMIARCH REPLACEMENT WERE PERFORMED USING A 28-MM DACRON TUBE GRAFT (HEMASHIELD; MEDOX MEDICAL INC, OAKLAND, NJ) UNDER SELECTIVE CEREBRAL PERFUSION. [...] THE PATIENT WAS EXTUBATED ON THE FIRST POSTOPERATIVE DAY. PERSISTENT SEROUS DRAINAGE BETWEEN 300 TO 400 ML PER DAY FROM THE MEDIASTINAL CHEST TUBE CONTINUED UNTIL THE POSTOPERATIVE DAY 10. HOWEVER, DRAINAGE BECAME PURULENT ON POSTOPERATIVE DAY 11. THEREFORE, THE PATIENT UNDERWENT URGENT SURGERY DUE TO A SUSPICION OF MEDIASTINITIS. CULTURES WERE OBTAINED AND TREATMENT WITH MEROPENEM AND VANCOMYCIN WAS EMPIRICALLY INITIATED. FOLLOWING RESTERNOTOMY, THE AORTIC GRAFT WAS EXPOSED. THE DACRON GRAFT WAS COVERED BY PURULENT DISCHARGE. ALL THE INFECTED TISSUES INCLUDING SOFT TISSUE AND STERNAL EDGES WERE DEBRIDED." "STREPTOCOCCUS VIRIDANS AND METHICILLIN-RESISTANT STAPHYLOCOCCUS EPIDERMIDIS WERE ISOLATED FROM THE MEDIASTINAL CULTURE." THE PATIENT AORTIC GRAFT INFECTION WAS TREATED BY THOROUGH DEBRIDEMENT OF ALL THE INFECTED TISSUES, FOLLOWED BY VAC THERAPY AND FINALLY COVERING THE INFECTED AORTIC GRAFT AND MEDIASTINUM WITH THE OMENTAL FLAP. IT IS STATED THAT "THE PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON POSTOPERATIVE DAY 15. ANTIBIOTIC TREATMENT WITH ORAL LINEZOLID WAS CONTINUED FOR 3 MONTHS. UNTIL NOW, THE PATIENT HAS BEEN FOLLOWED FOR 36 MONTHS WITH ANNUAL CTA IMAGING AND SHE HAS BEEN SYMPTOM- AND INFECTION-FREE." THE REFERENCE OF THE ARTICLE IS THE FOLLOWING: TÜRKÖZ R, DOGAN A, TÜRKEKUL Y, ÖZKER E. SUCCESSFUL TREATMENT OF THORACIC AORTIC GRAFT INFECTION BY OMENTAL FLAP FOLLOWING VACUUM-ASSISTED CLOSURE THERAPY. J CARD SURG. 2020;35:2857-2859. THE WEB ADDRESS LOCATION FOR THE ARTICLE IS THE FOLLOWING: HTTPS://DOI.ORG/10.1111/JOCS.14884. THE ARTICLE WAS INITIALLY PUBLISHED ON JULY 27, 2020.