HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

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) YEAR-OLD MALE WAS BORN WITH AN INTERRUPTED AORTIC ARCH (TYPEB2) AND A VENTRICULAR SEPTAL DEFECT, IN ADDITION TO DIGEORGE SYNDROME. HE WAS INITIALLY MANAGED WITH AN 8MM GORE-TEX GRAFT AS PART OF A STAGED APPROACH TO CONNECT THE DESCENDING AORTA, WHICH WAS LATER UPSIZED TO A 14-MM GORE-TEX TUBE GRAFT. THIS GRAFT WAS IN PLACE FOR 9 YEARS, AT WHICH TIME IT WAS REPLACED WITH A 22-MM HEMASHIELD WOVEN GRAFT. HE UNDERWENT A SURVEILLANCE MAGNETIC RESONANCE IMAGING (MRI) 11 YEARS AFTER IMPLANTATION OF THE HEMASHIELD TUBE GRAFT, WHICH DEMONSTRATED MARKED ANEURYSMAL DILATION OF THE MID-PORTION OF THE GRAFT, WHICH MEASURED 41MM AT ITS LARGEST POINT. THERE WAS A PERIOD OF INADEQUATE FOLLOW-UP, ENDING AFTER APPROXIMATELY 2 YEARS, WHEN HE PRESENTED AT AGE (B)(6) WITH HEMOPTYSIS AND EPISTAXIS. FURTHER IMAGING DEMONSTRATED A MORE PROMINENTLY DILATED GRAFT (53MM),WITH AN IRREGULAR AND ECTATIC INTIMAL APPEARANCE. HE SUFFERED AN ACUTE CARDIAC ARREST SHORTLY AFTER THE IMAGING WAS OBTAINED, AND UNDERWENT AN URGENT OPERATION TO REPAIR/REPLACE THE DILATED GRAFT. AT THE TIME OF SURGERY, THE HEMASHIELD WAS DENSELY ADHERENT TO THE LUNG AND ALL OVER THE MEDIASTINUM. THERE WAS NO EVIDENCE OF GROSS INFECTION. THERE WAS A SEGMENT OF THE HEMASHIELD GRAFT THAT APPEARED SPLAYED AND WAS DISRUPTED. THE DEGENERATED HEMASHIELD GRAFT WAS REMOVED, AND THE AORTIC ARCH WAS SUCCESSFULLY RECONSTRUCTED USING AORTIC HOMOGRAFT AND PATCH MATERIAL. HOWEVER, GIVEN THE ACUTE HEMODYNAMIC COMPROMISE AND RESULTING NEUROLOGIC INSULT THAT PRECEDED THE OPERATION, THE PATIENT DID NOT DEMONSTRATE ANY EVIDENCE OF BRAIN FUNCTION IN THE POSTOPERATIVE PERIOD. LIFE-SUSTAINING CARE WAS WITHDRAWN, AND THE PATIENT EXPIRED SHORTLY THEREAFTER. POSTMORTEM HISTOLOGIC EXAMINATION DEMONSTRATED DISRUPTION OF THE FABRIC WITH EXTENSIVE FIBROSIS, AS WELL AS EVIDENCE OF A DIFFUSE INFLAMMATORY REACTION WITH FOREIGN BODY GIANT CELLS. THERE WAS NO EVIDENCE OF INFECTION HISTOLOGICALLY, AND BOTH BACTERIAL AND FUNGAL CULTURES OF THE HOMOGRAFT MATERIAL WERE NEGATIVE. 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;33:653-657. THIS EVENT IS DESCRIBED AS "CASE 1" 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 2 = 1640201-2017-00026; 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 SAN DIEGO, 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 FIRST CASE. THIS EVENT IS LINKED TO THE 2 OTHER MEDICAL DEVICE REPORTS 1640201-2017-00024 AND 1640201-2017-00026.

Additional Manufacturer Narrative

IN SPITE OF REPEATED EFFORTS, NO ADDITIONAL INFORMATION COULD BE OBTAINED. THEREFORE, NO CONCLUSION CAN BE DRAWN.

Description of Event or Problem

IN SPITE OF REPEATED EFFORTS INCLUDING A FOLLOW-UP VISIT PERFORMED ON (B)(6) IN THE HOSPITAL BY THE CORPORATE MEDICAL OFFICER, NO ADDITIONAL INFORMATION COULD BE OBTAINED.