HEMASHIELD

Description of Event or Problem

SEE INITIAL MFR REPORT #1640201-2020-00020. COMPLAINT #(B)(4).

Additional Manufacturer Narrative

(4111/3221) THE INVESTIGATION INVOLVED A COMMUNICATION WITH THE AUTHOR TO THE EMAIL ADDRESS PROVIDED IN THE ARTICLE, BUT THE EMAIL DELIVERY WAS UNSUCCESSFUL. FURTHERMORE, THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE PRODUCT, EVENT AND PATIENT WERE MADE TO THE CO-AUTHOR¿S EMAIL ADDRESS; HOWEVER, ONE MONTH AFTER THE LAST ATTEMPT, NO ADDITIONAL INFORMATION WAS OBTAINED. THEREFORE, ON DECEMBER 30, 2020, THE INVESTIGATION FILE WAS CLOSED WITH THE AVAILABLE INFORMATION. (22) REPORTED ADVERSE EVENT KNOWN AND DOCUMENTED IN THE LABELING. THIS COMPLICATION (INFECTION) IS MENTIONED IN OUR RISK MANAGEMENT DOCUMENTATION. MOREOVER, BASED ON THE FOLLOWING PART OF THE ASSESSMENT OF OUR CORPORATE MEDICAL OFFICER : ¿ONE PATIENT OUT OF THE 101 WHERE AN AORTOBIFEMORAL BYPASS WAS PERFORMED DEVELOPED A GRAFT INFECTION (STAPHYLOCOCCUSAUREUS). [...] THIS COMPLICATION IS WELL DESCRIBED IN THE SCIENTIFIC LITERATURE AND ACCOUNTS FOR 0.5 TO 4% OF CASES. THE MOST FREQUENT PATHOGEN INVOLVED IS THE STAPHYLOCOCCUS AUREUS LIKE IT WAS FOR THE CASE ABOVE¿, 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¿. (4315) DUE TO THE LACK OF INFORMATION OBTAINED, THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. PLEASE NOTE THAT OCCURRENCES OF INFECTIONS WITH HEMASHIELD GRAFTS ARE THOROUGHLY MONITORED AND REVIEWED DURING MONTHLY QUALITY MEETINGS. 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.

Additional Manufacturer Narrative

THE PRODUCT WAS IMPLANTED AND EXPLANTED BETWEEN JANUARY 2001 AND DECEMBER 2011 HOWEVER THE EXACT DATES ARE UNKNOWN. DEVICE IS NOT ACCESSIBLE SINCE THE EVENT OCCURRED AT LEAST 9 YEARS AGO AND IT IS HIGHLY UNLIKELY THAT THE HOSPITAL WOULD HAVE KEPT THE INFECTED EXPLANT. 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. AS A COMPLEMENTARY INVESTIGATION, OUR MEDICAL CORPORATE OFFICER REVIEWED THE PUBLISHED ARTICLE AND PROVIDED US WITH HIS ASSESSMENT AS FOLLOWS: "THE ARTICLE DESCRIBES A RETROSPECTIVE REVIEW OF 229 PATIENTS WITH SYMPTOMATIC ILIAC ARTERY OCCLUSION SPLIT IN TWO INTERVENTION GROUPS: ILIAC ARTERY STENTING AND AORTOBIFEMORAL GRAFTING. ONE PATIENT OUT OF THE 101 WHERE AN AORTOBIFEMORAL BYPASS WAS PERFORMED DEVELOPED A GRAFT INFECTION (STAPHYLOCOCCUS AUREUS). THE GRAFT WAS REMOVED AND AN AUTOLOGOUS VEIN WAS USED AS A REPLACEMENT. THIS COMPLICATION IS WELL DESCRIBED IN THE SCIENTIFIC LITERATURE AND ACCOUNTS FOR 0.5 TO 4% OF CASES. THE MOST FREQUENT PATHOGEN INVOLVED IS THE STAPHYLOCOCCUS AUREUS LIKE IT WAS FOR THE CASE ABOVE. " (THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE FOR ANALYSIS.

Description of Event or Problem

THIS MEDICAL DEVICE REPORT FOLLOWS A REVIEW OF THE ARTICLE: "RESULTS OF ILIAC STENTING AND AORTOFEMORAL GRAFTING FOR ILIAC ARTERY OCCLUSIONS¿. THIS IS A RETROSPECTIVE REVIEW OF 229 PATIENTS (JANUARY 2000 TO DECEMBER 2011) TO COMPARE LONG-TERM RESULTS OF PERCUTANEOUS ILIAC ARTERY STENTING (PCIS) WITH AORTOBIFEMORAL (ABF) GRAFTING FOR PATIENTS WITH SYMPTOMATIC ILIAC ARTERY OCCLUSIONS. 103 PCIS PROCEDURES WERE PERFORMED AND 101 PATIENTS UNDERWENT ABF GRAFTING. ALL ABF PROCEDURES WERE PERFORMED IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA VIA A TRANSPERITONEAL APPROACH. IN ALL PATIENTS, A HEMASHIELD KNITTED DACRON GRAFT (MAQUET, WAYNE, NJ) WAS USED AS THE GRAFT CONDUIT. THIS STUDY DEMONSTRATES THAT PCIS REMAINS A SUITABLE, LESS INVASIVE FIRST-LINE THERAPY FOR ILIAC ARTERY OCCLUSIONS. IT ALSO STATES THAT ABF GRAFTING IS AN EFFECTIVE AND DURABLE VASCULAR RECONSTRUCTIVE OPTION FOR ILIAC ARTERY OCCLUSION. THE MOST COMMON COMPLICATIONS ENCOUNTERED IN THE ABF PATIENTS WERE PULMONARY. A GRAFT INFECTION (STAPHYLOCOCCUS AUREUS) DEVELOPED IN ONE PATIENT IN THE ABF GROUP AND REQUIRED REMOVAL OF THE GRAFT. THIS PATIENT UNDERWENT AUTOGENOUS VEIN RECONSTRUCTION (SPIRAL VEIN GRAFT) WITH A SATISFACTORY OUTCOME TO DATE (7 YEARS). THE REFERENCE OF THE ARTICLE IS THE FOLLOWING: SACHWANI ET AL , RESULTS OF ILIAC STENTING AND AORTOFEMORAL GRAFTING FOR ILIAC ARTERY OCCLUSIONS, JOURNAL OF VASCULAR SURGERY, 2013;57: 1030 - 1037. THE ARTICLE WAS INITIALLY PUBLISHED ON NOVEMBER 23, 2012. THE WEB ADDRESS LOCATION FOR THE ARTICLE IS THE FOLLOWING: HTTP://DX.DOI.ORG/10.1016/J.JVS.2012.09.038.