HEMASHIELD

Additional Manufacturer Narrative

THE EVENT OCCURRED IN (B)(6) 2009, HOWEVER THE EXACT EVENT DATE IS UNKNOWN. IT WAS ARBITRARILY SET TO (B)(6) 2009. DEVICE IS NOT ACCESSIBLE SINCE THE PATIENT DIED 10 YEARS AGO. NO INVESTIGATION COULD BE PERFORMED TO DATE SINCE THERE IS NO GRAFT IDENTIFICATION AVAILABLE. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. PLEASE NOTE THE EDITORIAL COMMENTARY AT THE END OF THE ARTICLE: "THIS IS AN INTERESTING ASSOCIATION, BUT TWO THINGS SHOULD BE BORNE IN MIND BY OUR READERSHIP. THE FIRST IS THE ANATOMIC PROXIMITY ITSELF. ALTHOUGH THE AORTIC ROOT IS CONTIGUOUS WITH THE LEFT VENTRICULAR OUTFLOW TRACT AND WITH THE AORTO-MITRAL FIBROUS CURTAIN BETWEEN THE AORTIC VALVE AND THE MITRAL VALVE, IT IS NOT CONTIGUOUS WITH THE RIGHT ATRIUM. THE SECOND ISSUE IS THE DIFFERENCE BETWEEN TEMPORAL ASSOCIATION AND CAUSAL ASSOCIATION. THERE IS A CLEAR TEMPORAL ASSOCIATION BETWEEN CARRYING A CIGARETTE LIGHTER AND THE DEVELOPMENT OF LUNG CANCER, BUT THE LIGHTER DOES NOT CAUSE LUNG CANCER: RATHER, THOSE PEOPLE WHO CARRY LIGHTERS ARE MUCH MORE LIKELY TO BE CIGARETTE SMOKERS. THE AUTHORS MAKE NO OUTRIGHT CLAIMS ABOUT CAUSATION IN THEIR CAREFULLY WRITTEN ARTICLE, AND IT IS IMPORTANT THAT SOMETHING AS COMMON IN CARDIOVASCULAR SURGERY AS THE IMPLANTATION OF DACRON INTO THE BODY NOT INSTILL FEAR OF CONSEQUENT SARCOMA".

Description of Event or Problem

THIS IS A PUBLISHED CASE REPORT OF PRIMARY CARDIAC ANGIOSARCOMA THAT DEVELOPED IN A WOMAN WHO HAD UNDERGONE AN AORTIC DISSECTION REPAIR WITH A DACRON GRAFT PROSTHESIS 9 YEARS EARLIER. IN (B)(6) 2009, A (B)(6) WOMAN PRESENTED WITH WORSENING SHORTNESS OF BREATH AND UPPER-BACK PAIN OF 1 MONTH'S DURATION. SHE HAD ALSO EXPERIENCED FATIGUE AND A 15-LB WEIGHT LOSS OVER THE PRECEDING MONTH. SHE DENIED CHEST PAIN, ORTHOPNEA, OR LOWER-EXTREMITY SWELLING. SHE WAS AFEBRILE, WITHOUT CHILLS OR NIGHT SWEATS. THE DIAGNOSIS WAS OF A PRIMARY CARDIAC ANGIOSARCOMA WITH EXTENSIVE MULTIORGAN METASTASES AND CONSEQUENT PATHOLOGIC THORACIC VERTEBRAL FRACTURE. HER CHRONIC AORTIC DISSECTIONS AND THE AORTIC PROSTHETIC GRAFT WERE STABLE. SHE WAS STARTED ON PACLITAXEL CHEMOTHERAPY. IN ADDITION, SHE UNDERWENT 6 SESSIONS OF RADIATION THERAPY TO HER THORACIC SPINE. HER CLINICAL CONDITION REMAINED STABLE FOR 2 WEEKS BUT DETERIORATED THEREAFTER, CHARACTERIZED BY WORSENING FATIGUE AND BACK PAIN. SHE CHOSE TO DISCONTINUE CHEMO- AND RADIOTHERAPY IN FAVOR OF HOSPICE CARE. SHE DIED 1 WEEK LATER. DACRON PROSTHESES HAVE RARELY BEEN ASSOCIATED WITH NEOPLASIA, AND NO CAUSAL RELATIONSHIP HAS BEEN ESTABLISHED. THE REFERENCE OF THE ARTICLE IS THE FOLLOWING: ALMEIDA NJ, ET AL. PRIMARY CARDIAC ANGIOSARCOMA IN A PATIENT WITH A DACRON AORTIC PROSTHESIS. TEX HEART INST J 2011;38(1):61-5. THE WEB ADDRESS LOCATION FOR THE COMPLETE CASE REPORT IS THE FOLLOWING: HTTPS://WWW.NCBI.NLM.NIH.GOV/PMC/ARTICLES/PMC3060733/PDF/20110200S00012P61.PDF.

Additional Manufacturer Narrative

AS A COMPLEMENTARY INVESTIGATION, OUR MEDICAL CORPORATE OFFICER CAREFULLY REVIEWED THE PUBLISHED ARTICLE AND ASKED FOR A THIRD-PARTY EXPERT OPINION. MEDICAL CORPORATE OFFICER ASSESSMENT: "THIS ARTICLE PRESENTS A CASE OF PRIMARY CARDIAC ANGIOSARCOMA IN A SIXTY YEARS OLD WOMAN NINE YEARS AFTER UNDERGOING A REPLACEMENT OF THE ASCENDING AORTA AND ARCH FOR A SPONTANEOUS AORTIC DISSECTION. CARDIAC ANGISARCOMAS ARE A VERY RARE OCCURRENCE AND ACCOUNT FOR AROUND 30% PERCENT OF ALL ANGIOSARCOMAS. THEY ARE USUALLY VERY AGGRESSIVE WITH POOR PROGNOSIS. THE AUTHORS OF THIS ARTICLE SUGGEST A POSSIBLE CONNECTION OF THE SARCOMA TO THE DACRON VASCULAR GRAFT IMPLANTED IN THE PATIENT BASED OF VICINITY (BY IMAGING) OF THE OCCURRENCE AND HISTORICAL LITERATURE. A PREVIOUS PRECLINICAL STUDY AND VERY FEW CASE REPORTS SUGGEST A POSSIBLE CAUSAL RELATIONSHIPS BETWEEN THE DACRON IMPLANT AND THE TUMOR BECAUSE OF THE INFLAMMATORY RESPONSE AND ITS 3-DIMENSIONAL POLYMERIC STRUCTURE. THE AUTHORS ALSO MENTION THAT A DIRECT CORRELATION CANNOT BE DRAWN CONCLUSIVELY AND THE VICINITY OF THE TUMOR TO THE DACRON COULD NOT BE CONFIRMED BECAUSE A BIOPSY WAS NOT PERFORMED. IT IS MY OPINION THAT BASED ON THIS ARTICLE AND FROM THE REVIEW OF PREVIOUS LITERATURE A CAUSAL RELATIONSHIP CANNOT BE MADE. " EXPERT OPINION: OUR CORPORATE OFFICER SPOKE WITH DR DILUOZZO DIRECTOR OF AORTIC PROGRAM AT MOUNT SINAI NYC WHO HAS AN EXTENSIVE REGISTRY OF PATIENTS WHERE ONE OF OUR GRAFTS WAS IMPLANTED . DR DILUOZZO DID NOT RECORD ANY INCIDENCE OF MALIGNANCY THAT COULD BE RELATED TO THE IMPLANTED PROSTHESIS. (4315) THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. WE WILL CONTINUE TO MONITOR COMPLAINT TRENDS MONTHLY AS REQUIRED BY OUR PROCEDURES TO DETECT ANY FURTHER SIGNALS. WE WILL ALSO CONTINUE TO PERIODICALLY REVIEW THE LITERATURE AS REQUIRED BY OUR PROCEDURES TO IDENTIFY ANY NEW PUBLICATION RELATING TO INTERVASCULAR PRODUCTS OR COMPETITOR DEVICES TO BE SURE ANY ADDITIONAL INFORMATION THAT WILL BECOME AVAILABLE WILL BE HANDLED ON A TIMELY MANNER. A NEW INVESTIGATION WILL BE PERFORMED IN CASE OF ANY ALARMING SIGNAL.