HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

THE DATE OF IMPLANTATION OF THE GRAFT WAS UNKNOWN UNTIL NOW; WAS COMPLETED BY MISTAKE IN INITIAL REPORT. THERE IS NO IMPORTER TO BE MENTIONED AND NO EXEMPTION TO BE APPLIED. DEVICE IS NOT ACCESSIBLE FOR TESTING. A THOROUGH ANALYSIS OF THE PUBLISHED ARTICLE BY A QUALIFIED HEALTHCARE PROFESSIONAL WILL BE PROVIDED. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THIS (B)(6) MALE PATIENT WAS BORN WITH A COMPLEX DEFECT INCLUDING D-TRANSPOSITION OF THE GREAT VESSELS, INTERRUPTED AORTIC ARCH (TYPE A), AND A LARGE VENTRICULAR SEPTAL DEFECT. THE INITIAL SURGICAL PALLATION CONSISTED OF A 10-MM GORE-TEX INTERPOSITION GRAFT (BASE OF THE INNOMINATE ARTERY TO THE DESCENDING AORTA) AND BANDING OF THE MAIN PULMONARY ARTERY, WHICH WAS FOLLOWED 4 YEARS LATER BY AN ARTERIAL SWITCH OPERATION AND CLOSURE OF THE VENTRICULAR SEPTAL DEFECT. AFTER A 10-YEAR PERIOD, THE INTERPOSITION GRAFT WAS REPLACED BY A 14-MM HEMASHIELD TUBE GRAFT. AFTER 15 YEARS, HE UNDERWENT A DIAGNOSTIC CATHETERIZATION IN THE SETTING OF INTERMITTENT CHEST PAIN AND RIGHT HEART FAILURE. ANGIOGRAPHY OF THE TUBE GRAFT DEMONSTRATED TWO AREAS OF STENOSIS, IN ADDITION TO AN AREA OF CONTRAST EXTRAVASATION. FURTHER IMAGING STUDIES WERE PERFORMED WHICH CONFIRMED THE FINDINGS ON ANGIOGRAPHY, AND DEMONSTRATED A LEAK OF THE INTERPOSITION GRAFT 5 CM DISTAL TO THE INNOMINATE ANASTOMOSIS. IN THE AREA OF THE DISRUPTION, THERE WAS ALSO A LARGE PSEUDOANEURYSM AND EVIDENCE OF INTRALUMINAL THROMBUS. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR SURGICAL INTERVENTION, AT WHICH TIME THE HEMASHIELD GRAFT WAS REMOVED AND REPLACED WITH A 16-MM GORE-TEX GRAFT. HOWEVER, THE PATIENT DEMONSTRATED SIGNIFICANT BLEEDING AND VENTRICULAR DYSFUNCTION INTRAOPERATIVELY. AS A RESULT, HE WAS UNABLE TO SEPARATE FROM CARDIOPULMONARY BYPASS. HE WAS TRANSITIONED TO ECMO FOR MYOCARDIAL RECOVERY AND TRANSFERRED TO THE CARDIAC INTENSIVE CARE UNIT. DESPITE FULL CIRCULATORY SUPPORT, HE DEVELOPED MULTISYSTEM ORGAN FAILURE. HE EXPIRED SHORTLY AFTER LIFE-SUSTAINING CARE WAS WITHDRAWN. THERE WAS NO EVIDENCE OF AN INFECTIOUS PROCESS BY HISTOLOGY OR CULTURES OBTAINED INTRAOPERATIVELY. THIS COMPLAINT CASE WAS REOPENED FOLLOWING THE PUBLICATION OF THE ARTICLE: AURIGEMMA D, BORQUEZ A, LEE J, ET AL. NON-ANASTOMOTIC FAILURE OF WOVEN DACRON TUBE GRAFTS IN THE THORACIC AORTA IN YOUNG ADULTS. J CARD SURG. 2018; 33:6 53-657. THIS EVENT IS DESCRIBED AS "CASE 2" IN THE ARTICLE AND TOOK PLACE SOMEWHERE BETWEEN MARCH 2014 AND MARCH 2017. THE 3 OTHER CASES DESCRIBED IN THE ARTICLE ARE REPORTED IN THE FOLLOWING MEDICAL DEVICE REPORTS: CASE 1 = 1640201-2017-00025, CASE 3 = 1640201-2018-00029, CASE 4 = 1640201-2017-00024.

Additional Manufacturer Narrative

DESPITE REPEATED ATTEMPTS, PRODUCT IDENTIFICATION WAS NEVER PROVIDED BY THE HOSPITAL. THEREFORE, NO MANUFACTURING INVESTIGATIONS, INCLUDING THE REVIEW OF THE DEVICE HISTORY RECORDS, COULD BE CONDUCTED. (4112/213/180) THE ARTICLE WAS ANALYZED BY THE CHIEF OF PEDIATRIC CARDIAC SURGERY AT (B)(6), WHO HAS BEEN A USER OF HEMASHIELD VASCULAR GRAFTS SINCE THE BEGINNING OF HIS NOW 20+ YEARS PRACTICE. HE HAS NEVER ENCOUNTERED ANYTHING EVEN SIMILAR TO THE EVENTS DESCRIBED IN THE ARTICLE. HE ALSO STATED THAT BECAUSE THESE EVENTS HAVE BEEN DESCRIBED IN ONE CENTER ONLY VERSUS FEW SINGLE ISOLATED OCCURRENCES DESCRIBED IN THE LITERATURE, A ROOT CAUSE SHOULD BE CONSIDERED FROM THE WAY THE GRAFTS WERE HANDLED DURING THE INITIAL OPERATION AND ON ANY SUBSEQUENT ENDOVASCULAR INTERVENTION PERFORMED ON THESE PATIENTS. (4109/213) BESIDES THESE FOUR CASES IN (B)(6), NO ASSOCIATED OR SIMILAR CASES WITH HEMASHIELD GRAFTS HAVE BEEN FOUND IN ANY OTHER COMPLAINT CASES TO DATE. (4315) THE CAUSE OF THE EVENTS REMAINS UNDETERMINED. GRAFT HANDLING DURING THE INITIAL PROCEDURE AND SUBSEQUENT ENDOVASCULAR PROCEDURES PERFORMED ON THESE PATIENTS SHOULD NOT BE EXCLUDED AS POTENTIAL CAUSES OF THE EVENT.

Additional Manufacturer Narrative

EXEMPTION E2017024 : INTERVASCULAR SAS (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF MAQUET CARDIOVASCULAR, LLC (IMPORTER). (3263/3221) THE PRODUCT IDENTIFICATION HAS NOT BEEN OBTAINED AT THE DATE OF THIS REPORT, THEREFORE NO DEVICE HISTORY RECORDS EVALUATION COULD HAVE BEEN PERFORMED. IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE HOSPITAL REPORTED AN ISSUE WITH GRAFT FAILURES INVOLVING TWO DEATHS. THIS REPORTING CORRESPONDS TO THE SECOND CASE. THIS EVENT IS LINKED TO THE 2 OTHER MEDICAL DEVICE REPORTS 1640201-2017-00024 AND 1640201-2017-00025. IT SHOULD BE NOTED THAT THE COMPLAINT SITUATION WAS INITIALLY REPORTED ON (B)(6) 2017 BUT IT HAS NEVER BEEN RECEIVED BY THE COMPLAINT DEPARTMENT HANDLING UNIT. IT WAS THEREFORE SUBMITTED AGAIN AND RECEIVED BY THE INTERVASCULAR DESIGNATED COMPLAINT HANDLING UNIT ON (B)(6) 2017.

Description of Event or Problem

IN SPITE OF REPEATED EFFORTS INCLUDING A FOLLOW-UP VISIT PERFORMED ON AUGUST THE 8TH IN THE HOSPITAL BY THE CORPORATE MEDICAL OFFICER, NO ADDITIONAL INFORMATION COULD BE OBTAINED.