HEMASHIELD PLATINUM WOVEN STRAIGHT

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

CORRECT DATA: BLOCK D4 IT WAS IDENTIFIED THAT THE UNIQUE DEVICE IDENTIFIER (UDI) REPORTED IN THE INITIAL SUBMISSION (INITIAL MDR #1640201-2025-0000017 SUBMITTED ON 04-JULY-2025) WAS INCORRECT DUE TO A DATA ENTRY ERROR. THEREFORE, THE UDI HAS BEEN CORRECTED IN THIS FOLLOW UP REPORT. ADDITIONAL MANUFACTURER NARRATIVE: (10/4248) A FRAGMENT OF THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR FOR EXAMINATION THEN SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY. THE MACROSCOPIC ANALYSIS OF EXPLANT DID NOT REVEAL ANY MACROSCOPIC DEFECTS IN TEXTILE STRUCTURE BEFORE WASHING THE EXPLANT. NO FRAYING WAS OBSERVED DURING THE ANALYSIS. (4112/4248) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT WHO CONCLUDED THAT IT IS LIKELY THAT THE LOOSE THREADS OBSERVED BY THE SURGEON AFTER CUTTING THE GRAFT ARE DUE TO THE USE OF SCISSORS INSTEAD OF LOW TEMPERATURE DISPOSABLE CAUTERY AS INDICATED IN THE IFU. (4110/213) THE ACTUAL OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS ON THE HEMASHIELD PRODUCTS FOR THE PERIOD 01-SEPT-2024 TO 30-AUG-2025. THE OBSERVED OCCURRENCE RATE FOR THE IDENTIFIED RISK WAS 0,001% , WHICH IS COMPLIANT WITH THE REQUIREMENT OF BEING LESS THAN OR EQUAL TO THE ANTICIPATED MAXIMUM OCCURRENCE RATE OF 0.001%. (67/18) BASED ON THE INVESTIGATION FINDINGS, IT IS CONCLUDED THAT THE LOOSE THREADS OBSERVED BY THE SURGEON AFTER CUTTING THE GRAFT ARE LIKELY DUE TO THE USE OF SCISSORS INSTEAD OF A LOW-TEMPERATURE DISPOSABLE CAUTERY AS INDICATED IN THE IFU. NEVERTHELESS, THE PRODUCT ANALYSIS DID NOT REVEAL THE PRESENCE OF THE REPORTED THREADS. TO BE NOTED THAT PER INSTRUCTION FOR USE OF HEMASHIELD PLATINUM WOVEN VASCULAR GRAFTS, DUE TO THEIR INTRINSIC WEAVING PATTERN, WOVEN GRAFTS ARE MORE PRONE TO FRAYING. THE WARNING SECTION STATES THAT WOVEN GRAFTS SHOULD NOT CUT WITH SCISSORS OR SCALPELS TO LIMIT THE RISK OF GRAFT FRAYING. IN ADDITION, THE SECTION DIRECTIONS FOR USE OF THE IFU STATES THE FOLLOWING: ¿AS WITH ALL THE WOVEN PRODUCTS, THE HEMASHIELD PLATINUM WOVEN VASCULAR GRAFTS SHOULD BE CUT WITH A LOW-TEMPERATURE DISPOSABLE CAUTERY (E.G., 900°F / 500°C) TO MINIMIZE FRAYING.'

Additional Manufacturer Narrative

(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24K30. (10/3233) IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE IN RELATION WITH THE EVENT REPORTED. (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 DURING AN ANEURYSM PROCEDURE, THE SURGEON AND THE NURSES EXPERIENCED THAT THREADS FROM THE PROSTHESIS SIMPLY FELL DOWN ONTO THE OPERATION FIELD AND THE PATIENT AND BEFORE BEING REMOVED. THE INVOLVED DEVICE IS AVAILABLE FOR EXAMINATION THE PROSTHESIS WAS CUT WITH SCISSORS. COMPLAINT #(B)(4).