HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

DUE TO SIMILARITIES OF THE EVENTS DESCRIBED IN THE MFR REPORTS #1640201- 2018-00019, #1640201- 2018-00020, #1640201-2019-00021 #1640201-2019-00022,AND #1640201-2019-00077, A HEALTH HAZARD EVALUATION HAS BEEN INITIATED IN RELATION WITH THESE FIVE CASES AND ASSESSED BY OUR CORPORATE MEDICAL OFFICER. PROBABILITY AND HEALTH RISK ARE DESCRIBED AS FOLLOWS: "THE MOST LIKELY OCCURRENCE AS A CONSEQUENCE OF THIS HOLE BLEEDING IS A PROCEDURAL DELAY DUE TO THE NECESSITY TO PERFORM AN ADDITIONAL HEMOSTASIS MEASURE. THE DELAY IS EXPECTED TO BE LIMITED AND NOT IMPACTING THE FLOW OF THE OPERATION AND ITS OUTCOME. IN THE EVENT OF INTRAOPERATIVE BLEEDING, IT WOULD, IN MOST CASES, BE CONTROLLED BY COMPRESSION, CLOTTING AGENT APPLICATION OR A SIMPLE SUTURE. THIS HOWEVER, CAN OCCASIONALLY RESULT IN A SERIOUS OR EVEN CRITICAL SITUATIONS FOR EITHER GENERAL OR AT GREATEST RISK POPULATIONS RESPECTIVELY. REOPERATION TO CONTROL POSTOPERATIVE BLEEDING IS A REMOTE POSSIBILITY THAT CAN BE CRITICAL ESPECIALLY FOR THE POPULATION AT GREATEST RISK. HOWEVER THE PRESENCE OF MEDIASTINAL DRAINAGE WILL MITIGATE THE POTENTIAL INCIDENCE OF TAMPONADE AND HELP IN PROMPTLY DETECT AN UNUSUAL BLEEDING. THE CRITICALITY OF THIS EVENT FOR THE HIGH-RISK POPULATION DERIVES FROM THE RE-OPERATION AND THE POTENTIAL IMPACT ON THE ALREADY DELICATE OVERALL CONDITION" FOLLOWING THIS EVALUATION, INTERVASCULAR HAS DECIDED TO WITHDRAW FROM THE MARKET ALL PRODUCTS POTENTIALLY AFFECTED. 1710 DEVICES ARE INVOLVED (RECALL # RC034 INITIATED ON 23-MAR-2020) (25) A CAPA (#281548) HAS BEEN INITIATED IN ORDER TO INVESTIGATE AND TAKE APPROPRIATE CORRECTIVE ACTIONS. THE MOST LIKELY ROOT CAUSE(S) MAY BE A COMBINATION OF CONDITIONS: LINKED TO THE SLIGHT STRETCHING OF THE WOVEN FABRIC EXPECTED DURING THE SEWING OPERATION, AS EXPLAINED IN INITIAL MFR REPORT #1640201- 2018-00019, #1640201- 2018-00020 (COMPLAINT #(B)(4) AND # (B)(4)). LINKED TO THE SEWING OPERATOR BEING STRESSED AFTER HAVING BEEN INFORMED ABOUT THE FIRST 2 COMPLAINTS (FOR THE THREE ADDITIONAL SIMILAR EVENTS, SEE INITIAL MFR REPORT #1640201-2019-00021, #1640201-2019-00022 AND #1640201-2019-00077 ; COMPLAINT # (B)(4)).

Additional Manufacturer Narrative

DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. THESE TESTS INCLUDE A 100% VISUAL INSPECTION OF THE GRAFT USING A BACKLIT TABLE TO REVEAL THE PRESENCE OF ANY HOLES IN THE TEXTILE STRUCTURE. THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

TWO HOLES WERE FOUND BETWEEN THE PERFUSION BRANCH AND THE MAIN BODY OF THE GRAFT. IT WAS REPORTED THAT THE FIRST HOLE WAS CLOSED BY PLEDGET SUTURE AND THE SECOND HOLE WAS CLOSED BY 5/0 PROLENE WITH PLEDGET SUTURE. NO INJURY TO THE PATIENT WAS REPORTED. A VIDEO AND PICTURES WERE PROVIDED.