HEMASHIELD

Additional Manufacturer Narrative

THE IMPLANTED DATE IS UNKNOWN, HOWEVER THE PRODUCT WAS IMPLANTED. DEVICE IS NOT ACCESSIBLE AS IT REMAINED IMPLANTED. AN ATTEMPT TO CONTACT THE AUTHOR IS ONGOING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. WEB ADDRESS LOCATION FOR THE ARTICLE : HTTPS://DOI.ORG/10.1016/J.AVSG.2019.08.101.

Description of Event or Problem

THIS IS A PUBLISHED CASE REPORT OF A (B)(6) YEARS OLD MAN WITH TYPE A AORTIC DISSECTION. THE PATIENT NECESSITATED AN EMERGENT AORTIC ROOT AND ARCH REPLACEMENT WITH FROZEN ELEPHANT TRUNK PROCEDURE, WITH DISTAL AORTIC ANASTOMOSIS PROXIMAL TO LEFT SUBCLAVIAN ARTERY (LSCA), FOLLOWED BY AN ANTEGRADE DEPLOYMENT OF A THORACIC ENDOGRAFT COVERING LCSA. INNOMINATE ARTERY (IA) AND LEFT COMMON CAROTID ARTERY (LCCA) WERE BYPASSED FROM ASCENDING AORTA WITH A BIFURCATED HEMASHIELD GRAFT. THE HEMASHIELD MODEL IS UNKNOWN. ON POSTOPERATIVE DAY 6, THE PATIENT DEVELOPED ALTERED MENTAL STATUS. THE PATIENT HAD PALPABLE LEFT CAROTID PULSES; HOWEVER, CTA REVEALED A PSEUDOANEURYSM OF THE LCCA BYPASS AND A DISSECTION DISTALLY EXTENDING TO THE PROXIMAL INTERNAL CAROTID ARTERY (ICA), CAUSING SEVERE COMPRESSION OF THE TRUE LUMEN AND FLOW LIMITATION TO THE LEFT ICA. THE CASE REPORT DESCRIBES THE PROCEDURE TO REPAIR THE LEFT CAROTID PSEUDOANEURYSM AND DISSECTION. THE PATIENT CONTINUED REHABILITATION AND WAS DISCHARGED HOME ON POSTOPERATIVE DAY 36.

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: THE CASE HAS BEEN REVIEWED BY OUR CORPORATE MEDICAL OFFICER. HIS ASSESSMENT IS AS FOLLOWS: ¿THE EVENT DESCRIBED [IN THE ARTICLE] INCLUDES THE PROCEDURAL DETAILS. ON DAY SIX POST-OP THE PATIENT EXPERIENCED AN ALTERATION OF HIS MENTAL STATUS. AFTER IMAGING IT WAS FOUND A PSEUDO-ANEURYSM OF THE LEFT CAROTID ARTERY AND A DISSECTION THAT WAS LIMITING THE FLOW THROUGH THE VESSEL. THE COMPLICATION DESCRIBED IS A POSSIBLE OUTCOME THAT IS WELL KNOWN BY THE SURGEON AND IT IS INDEPENDENT TO THE GRAFT USED TO BYPASS THE VESSEL AND DEPENDENT TO THE UNDERLINING DISEASE PROGRESSION (DISSECTION).¿ THE INVESTIGATION INVOLVED A COMMUNICATION WITH THE AUTHOR AND PERSONS CLOSE TO THE ADVERSE EVENT. HOWEVER, DESPITE THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE PRODUCT, EVENT AND PATIENT, NO ADDITIONAL INFORMATION WAS OBTAINED. NO GRAFT IDENTIFICATION WAS PROVIDED DESPITE ATTEMPTS TO CONTACT THE AUTHOR OF THE ARTICLE AND PERSONS CLOSE TO THE ADVERSE EVENT. THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORDS CAN BE PERFORMED AND THEREFORE NO RESULTS WILL BE OBTAINED. LOT NUMBER WAS PROVIDED DESPITE ATTEMPTS TO CONTACT THE AUTHOR OF THE ARTICLE AND PERSONS CLOSE TO THE ADVERSE EVENT. THEREFORE, THE ANALYSIS OF HISTORICAL DATA CONCERNING THE SAME LOT NUMBER CANNOT BE PERFORMED AND THEREFORE NO RESULTS WILL BE OBTAINED. BASED ON THE FOLLOWING PART OF THE ASSESSMENT OF OUR CORPORATE MEDICAL OFFICER ¿THE COMPLICATION DESCRIBED IS A POSSIBLE OUTCOME THAT IS WELL KNOWN BY THE SURGEON AND IT IS INDEPENDENT TO THE GRAFT USED TO BYPASS THE VESSEL AND DEPENDENT TO THE UNDERLINING DISEASE PROGRESSION (DISSECTION)¿ WE CONCLUDE THAT IT IS AN ADVERSE EVENT RELATED TO PATIENT CONDITION.

Description of Event or Problem

SEE INITIAL MFR REPORT N°: 1640201-2020-00005. COMPLAINT (B)(4).