HEMASHIELD PLATINUM WOVEN BIFURCATED

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT A PATIENT WAS PRESENTING WITH RECURRENT PERIPROSTHETIC PURULENT COLLECTIONS, WHICH WERE STERILE AFTER CULTURE. GIVEN THE RECURRENCE OF THESE EVENTS, A HYPERSENSITIVITY REACTION TO VASCULAR PROSTHESES HAS BEEN SUGGESTED BY THE HOSPITAL. THE PATIENT HAS THREE PROSTHESES MANUFACTURED BY INTERVESICULAR: - ONE HEMASHIELD PRODUCT WHICH IS THE SUBJECT OF THIS REPORT. - THE TWO OTHER DEVICES ARE INTERGARD SILVER GRAFTS. COMPLAINT #(B)(4).

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

CORRECTIVE DATA: IN BLOCK B5 DESCRIBE EVENT OR PROBLEM WAS UPDATED TO INDICATE THAT THE PATIENT HAS 5 PROSTHESES MANUFACTURED BY INTERVASCULAR: ONE HEMASHIELD PRODUCT WHICH IS THE SUBJECT OF THIS REPORT. THE 4 OTHER DEVICES ARE INTERGARD SILVER GRAFTS. (4111) ATTEMPTS TO CONTACT THE INITIAL REPORTER IN ORDER TO GET MORE INFORMATION ABOUT THE PATIENT INFORMATION THE INVOLVED PRODUCTS WERE REQUESTED AND RESPONSES ABOUT THE MULTIPLE PROCEDURES PERFORMED WERE PROVIDED AS FOLLOWS: ABOUT THE IMPLANTED DEVICES AND THE PATIENT'S HISTORY: 59 YEAR OLD MALE, 88 KG 2008 RIGHT TO LEFT FEM FEM UNKNOWN GRAFT 2010 FEM FEM ADVANTA SST TRI LAMINATE 2011 AORTO BI FEM HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR (WHICH IS THE SUBJECT TO THIS MDR) 2014 AORTO SUPERFICIAL FEM INTERGARD ULTRATHIN SILVER KNITTED STRAIGHT (B)(6) 2021 INFECTIOUS DISEASES CONSULT: ATB THERAPY INITIATED (NEGATIVE SAMPLES) (B)(6) AXILOFEMORAL BYPASS INTERGARD SILVER ULTRATHIN KNITTED REINFORCED GELSOFT PLUS (TERUMO) ON (B)(6) PERIPROSTHETIC COLLECTION DETECTED; DRAINED ON (B)(6) 2022 28 MARCH ILIOFEMORAL BYPASS W/INTERGARD SILVER ULTRATHIN ATB THERAPY (B)(6) 2023 INFECTIOUS DISEASES CONSULT PATIENT WAS ADMITTED (B)(6) NO PERIPROSTHETIC COLLECTION OBSERVED ON ANGIOSCAN (CT ANGIOGRAPHY) NOVEMBER DECEMBER PERIPROSTHETIC COLLECTIONS SURROUNDING LEFT AXILLOFEMORAL BYPASS AND RIGHT ILIOFEMORAL BYPASS OBSERVED IN ABDOMINOPELVIC CT SCAN DECEMBER CONSULT WITH VASCULAR SURGERY NEEDLE ASPIRATION PERFORMED, STERILE CULTURES, ATB THERAPY (B)(6) 2024 ADMITTED FOR TREATMENT OF PURULENT COLLECTION AROUND LEFT AXILLO FEMORAL AND RIGHT AORTOILIAC BYPASS JULY RIGHT LOWER ISCHEMIA; THROMBUS POSITIVE FOR STAPH AUREUS (MRSA) DECEMBER RIGHT LOWER LIMB INTERGARD ULTRATHIN SILVER STRAIGHT KNITTED DECEMBER BLOOD CULTURE SAMPLES WITH STAPH AUREUS (MSSA), STAPH LUGDUNENSIS, AND STREPTOCOCCUS PYOGENES (GROUP A) (B)(6) 2025 ATB TREATMENT FOR DEEP COLLECTION AROUND AXILLOFEMORAL PROSTHESIS; NO DETECTABLE BACTERIA IDENTIFIED.. (4112/213) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT WHOSE CONCLUSION IS AS FOLLOWS : EIGHT (8) VASCULAR GRAFTS HAVE BEEN IMPLANTED FOR TREATMENT OF VASCULAR OCCLUSIVE AND ANEURYSMAL DISEASE OVER THE LAST 16 YEARS. ACCORDING TO THE INFORMATION PROVIDED THERE IS NO CLEAR INDICATION OF AN ALLERGIC REACTION TO THE IMPLANTED PROSTHESIS. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINTS WERE REPORTED FOR THE FOLLOWING STERILIZATION LOTS NUMBER 21C18, 14D03, 21L18, 24F13, 25039001. (3331/213) THE DEVICE HISTORY RECORDS REVIEW FOR THE HEMASHIELD PRODUCT WAS REQUESTED TO THE FORMER MANUFACTURER OF HEMASHIELD GRAFTS. HOWEVER, IT COULD NOT BE PROVIDED. TO BE NOTED THAT THE DEVICE HISTORY RECORDS WAS REVIEWED FOR THE FOUR OTHER GRAFT (INTERGARD SILVER) MANUFACTURED BY INTERVASCULAR SAS. THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (4110/213) ALLERGIC REACTION OCCURRENCE RATE WAS CALCULATED (INCLUDING THIS COMPLAINT) ON THE SAME PRODUCT FAMILY (HEMASHIELD GRAFTS) FROM 01 JULY 24 TO 30 JUNE 25. THE OCCURRENCE RATE IS (B)(4), WHICH IS EQUAL THE MAXIMUM ANTICIPATED OCCURRENCE RATE OF < =0.001% FOR THE IDENTIFIED RISK. (4315) BASED ON ALL THE AVAILABLE INFORMATION, THE INVESTIGATION FINDINGS AND SPECIFICALLY THE MEDICAL ASSESSMENT, THERE IS NO CLEAR INDICATION OF AN ALLERGIC REACTION TO THE IMPLANTED GRAFTS. THEREFORE, IT IS NOT POSSIBLE TO CONCLUDE ON THE EXACT ORIGIN OF THE REPORTED ADVERSE EVENT. (22) NEVERTHELESS, IT SHOULD BE NOTED THAT ALLERGIC REACTION IS AN UNDESIRABLE SIDE EFFECTS AS MENTIONED IN THE HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR INSTRUCTIONS FOR USE AS FOLLOWS: A POTENTIAL FOR A SLIGHT IMMUNOLOGICAL REACTION, EVIDENCED BY A SLIGHT RISE IN BODY TEMPERATURE, MAY BE ASSOCIATED WITH ALL COLLAGEN COATED VASCULAR PRODUCTS.

Description of Event or Problem

COMPLAINT # (B)(4). THE INITIAL INFORMATION WAS UPDATED TO INDICATE THAT THE PATIENT HAS 5 PROSTHESES MANUFACTURED BY INTERVASCULAR: ONE HEMASHIELD PRODUCT WHICH IS THE SUBJECT OF THIS REPORT. THE 4 OTHER DEVICES ARE INTERGARD SILVER GRAFTS.