HEMASHIELD GRAFT

Description of Event or Problem

COMPLAINT # (B)(4).

Additional Manufacturer Narrative

CORRECTIVE DATA: ON BLOCK B1, THE TYPE OF REPORT "ADVERSE EVENT AND PRODUCT PROBLEM" WAS UPDATED TO "PRODUCT PROBLEM". ON BLOCK H6, THE HEALTH EFFECT - CLINICAL CODE "4580" AND THE HEALTH EFFECT - IMPACT CODE "4642" AND "4625" WERE REMOVED. ON BLOCK H1, THE REPORTABLE EVENT TYPE "SERIOUS INJURY" WAS UPDATED TO "MALFUNCTION". BASED ON THE MEDICAL ASSESSMENT, IT IS CONCLUDED THAT THERE IS NO MALFUNCTION OR SERIOUS INJURY RELATED TO USE OF THE HEMASHIELD GRAFT. WHILE THE SURGEON EXPRESSED CONCERNS REGARDING ADHESION FORMATION, THIS FEEDBACK REFLECTS CLINICAL PREFERENCE AND SURGICAL HANDLING CONSIDERATIONS RATHER THAN AN MALFUNCTION OR A SERIOUS INJURY. ALTHOUGH NO MALFUNCTION WAS CONFIRMED, THE EVENT WAS REPORTED UNDER THE MANDATORY REPORTABLE EVENT FIELD ¿MALFUNCTION¿ IN ACCORDANCE WITH 21FR PART 803 REQUIREMENTS IN ORDER TO PROVIDE THE CONCLUSION OF THE COMPLAINT ASSESSMENT.. ADDITIONAL INFORMATION ( 4111/3221) DESPITE OUR ATTEMPTS TO CONTACT THE SURGEON TO OBTAIN MORE INFORMATION ABOUT THE SURGICAL PROCEDURE, PATIENT INFORMATION AND THE INVOLVED PRODUCT (SERIAL NUMBER, REFERENCE AND LOT NUMBER) NO RESPONSE COULD BE OBTAIN. MOREOVER, THE LOCATION OF THE DEVICE REMAINS UNKNOWN, AND NO INVESTIGATION COULD BE PERFORMED. (4112/213) THE CASE HAS BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT WHO CONCLUDED THE FOLLOWING: "THIS COMPLAINT CONCERNS HEMASHIELD GRAFTS IN GENERAL AND STEMS FROM A CONVERSATION ABOUT THE REOPERATION OF A PATIENT WHO HAD PREVIOUSLY RECEIVED A HEMASHIELD KNITTED GRAFT. THE DISCUSSION TOOK PLACE BETWEEN DR. (B)(6) AND SALES REPRESENTATIVE (B)(6), FOLLOWING MS. (B)(6) NOTIFICATION OF AN UPCOMING PRODUCT REPLACEMENT AT DR. (B)(6) HOSPITAL. DR. (B)(6), CHIEF PHYSICIAN AND PROFESSOR (B)(6) HOSPITAL IN (B)(6), SHARED HIS RECENT EXPERIENCE WITH A REOPERATION INVOLVING A HEMASHIELD KNITTED GRAFT. HE REPORTED ENCOUNTERING SIGNIFICANT ADHESIONS BETWEEN THE GRAFT AND THE PULMONARY ARTERY, WHICH MADE THE DISSECTION MORE CHALLENGING AND INCREASED THE SURGICAL RISK. IT IS IMPORTANT TO NOTE THAT THE NEED FOR REOPERATION WAS NOT DIRECTLY ATTRIBUTED TO THE USE OF THE HEMASHIELD GRAFT. BASED ON THIS EXPERIENCE, DR.(B)(6) STATED THAT HE NO LONGER INTENDS TO USE HEMASHIELD GRAFTS, CITING THEIR TENDENCY TO FORM EXCESSIVE ADHESIONS THAT COMPLICATE REOPERATIONS. HE EXPRESSED A PREFERENCE FOR EXCLUSIVELY USING VASCUTEK GRAFTS MOVING FORWARD, AS HE BELIEVES THEY DO NOT PRESENT THE SAME ADHESION RELATED ISSUES. MULTIPLE GOOD-FAITH ATTEMPTS WERE MADE TO CONTACT DR. (B)(6) TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT¿S CURRENT CONDITION AND FURTHER DETAILS ABOUT THE SURGERY; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. IT IS WORTH NOTING THAT TISSUE INTEGRATION OR INGROWTH IS GENERALLY CONSIDERED ONE OF THE ADVANTAGES OF BOTH KNITTED AND WOVEN POLYESTER VASCULAR GRAFTS." (67) BASED ON THE MEDICAL ASSESSMENT, IT WAS CONCLUDED THAT NO DEVICE MALFUNCTION OR SERIOUS INJURY WAS IDENTIFIED. THE NEED FOR REOPERATION WAS EXPLICITLY NOT ATTRIBUTED TO THE HEMASHIELD GRAFT, AND THE ADHESIONS OBSERVED ARE CONSISTENT WITH THE EXPECTED TISSUE INTEGRATION CHARACTERISTICS OF POLYESTER VASCULAR GRAFTS. THERE IS NO EVIDENCE OF PATIENT HARM OR SERIOUS DETERIORATION IN HEALTH ASSOCIATED WITH THE DEVICE. WHILE THE SURGEON EXPRESSED CONCERNS REGARDING ADHESION FORMATION, THIS FEEDBACK REFLECTS CLINICAL PREFERENCE AND SURGICAL HANDLING CONSIDERATIONS RATHER THAN A MALFUNCTION OR SERIOUS INJURY AS DEFINED IN THE 21CFR PART 803.

Additional Manufacturer Narrative

(4117) FROM THE INITIAL INFORMATION RECEIVED, IT IS UNKNOWN WHETHER THE INVOLVED PRODUCT IS AVAILABLE FOR ANALYSIS. (4111/3233) ATTEMPTS TO CONTACT THE INITIAL REPORTER IN ORDER TO GET MORE INFORMATION ABOUT THE SURGICAL PROCEDURE, PATIENT INFORMATION AND THE INVOLVED PRODUCT (SERIAL NUMBER, REFERENCE AND LOT NUMBER) IS ONGOING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT A CASE OF RE-OPERATION HAD OCCURRED, INVOLVING THE USE OF A HEMASHIELD PRODUCT. THE SURGEON INDICATED THAT THE HEMASHIELD PROSTHESIS USED HAD BECOME VERY DEEPLY INGROWN. THIS LED TO DELAYS AND AN UNFAVORABLE SITUATION, WHICH THE SURGEON CONSIDERS DANGEROUS. THE IMPLANTATION AND EXPLANTATION DATES ARE UNKNOWN. COMPLAINT #(B)(4).