HEMASHIELD

Description of Event or Problem

SEE INITIAL MFR REPORT N°: 1640201-2020-00007. COMPLAINT # (B)(4).

Additional Manufacturer Narrative

ADDITIONAL NARRATIVE: THE CASE HAS BEEN REVIEWED BY OUR CORPORATE MEDICAL OFFICER. HIS ASSESSMENT IS AS FOLLOWS: ¿THE PATIENTS HISTORY AND PROCEDURAL DETAILS ARE DESCRIBED IN THE [ARTICLE]. THE ASSESSMENT REGARDS THE FINDINGS OF A 14 MM HEMASHIELD DACRON GRAFT USED TO PERFORM A BYPASS BETWEEN THE ASCENDING [AORTA AND THE] DESCENDING THORACIC AORTA AFTER OVER TEN YEARS OF BEING IMPLANTED. THE PATIENT BECAME SYMPTOMATIC AND A CT ANGIOGRAPHY WAS PERFORMED. THE DACRON GRAFT RESULTED TORTUOUS, CALCIFIED AND SEVERELY STENOTIC AT ITS DISTAL PORTION NEAR THE ANASTOMOSIS TO THE DESCENDING AORTA. THE PATHOLOGIC CHANGES IDENTIFIED ARE COMPATIBLE WITH THE USE OF THIS GRAFT IN THIS PARTICULAR EXTRA-ANATOMICAL LOCATION AND WITH THE DURATION OF THE IMPLANT. THE LESIONS WERE ADDRESSED USING SEVERAL SELF-EXPANDABLE STENTS POST-DILATED TO 14 MM. THE CORRECTION WAS SUCCESSFUL AND THE PATIENT HAD AN UNEVENTFUL RECOVERY.¿ (4111/3221) THE INVESTIGATION INVOLVED A COMMUNICATION WITH THE AUTHOR. HOWEVER, DESPITE THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ON THE PRODUCT, EVENT AND PATIENT, NO ADDITIONAL INFORMATION WAS OBTAINED. (3331/3221) NO GRAFT IDENTIFICATION WAS PROVIDED DESPITE ATTEMPTS TO CONTACT THE AUTHOR OF THE ARTICLE. THEREFORE, NO REVIEW OF THE DEVICE HISTORY RECORDS CAN BE PERFORMED AND THEREFORE NO RESULTS WILL BE OBTAINED. (4109/3221) NO LOT NUMBER WAS PROVIDED DESPITE ATTEMPTS TO CONTACT THE AUTHOR OF THE ARTICLE. THEREFORE, THE ANALYSIS OF HISTORICAL DATA CONCERNING THE SAME LOT NUMBER CANNOT BE PERFORMED AND THEREFORE NO RESULTS WILL BE OBTAINED. (22) BASED ON THE FOLLOWING PART OF THE ASSESSMENT OF OUR CORPORATE MEDICAL OFFICER ¿THE PATHOLOGIC CHANGES IDENTIFIED ARE COMPATIBLE WITH THE USE OF THIS GRAFT IN THIS PARTICULAR EXTRA-ANATOMICAL LOCATION AND WITH THE DURATION OF THE IMPLANT¿ WE CONCLUDE THAT IT IS A KNOWN INHERENT RISK OF DEVICE. PLEASE NOTE THAT, AS INDICATED IN THE LAST APPROVED VERSION OF THE PRODUCT INSTRUCTIONS FOR USE: ¿POTENTIAL COMPLICATIONS WHICH MAY OCCUR IN CONJUNCTION WITH THE USE OF ANY VASCULAR PROSTHESIS INCLUDE THROMBOSIS, EMBOLIC EVENTS, OCCLUSION AND STENOSIS, INTIMAL HYPERPLASIA WHICH COULD CAUSE RECURRENT SYMPTOMS, INFECTION, SEPSIS, PERIGRAFT FLUID, SEROMA FORMATION, BLEEDING, HEMATOMA, FEVER, INFLAMMATORY REACTION, PSEUDOANEURYSM, ANASTOMOTIC ANEURYSM, STROKE, DILATATION OF THE PROSTHESIS, ANASTOMOTIC DISRUPTION OR TEARING OF THE SUTURE LINE AND/OR HOST VESSEL¿.

Additional Manufacturer Narrative

IMPLANT DATE LEFT EMPTY BECAUSE THE IMPLANTED DATE IS UNKNOWN, HOWEVER THE PRODUCT WAS IMPLANTED MORE THAN 10 YEARS AGO. DEVICE IS NOT ACCESSIBLE AS IT REMAINED IMPLANTED. AN ATTEMPT TO CONTACT THE AUTHOR IS ONGOING. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. "WEB ADDRESS LOCATION FOR THE ARTICLE : HTTPS://ONLINELIBRARY.WILEY.COM/DOI/ABS/10.1002/CCD.28389.

Description of Event or Problem

(B)(4). THIS IS A PUBLISHED CASE REPORT OF A (B)(6) WITH A POSTERIO-MALALIGNED VENTRICULAR SEPTAL DEFECT (VSD) AND TYPE B INTERRUPTED AORTIC ARCH WITH ABERRANT RIGHT SUBCLAVIAN ARTERY (RSCA) THAT WAS INITIALLY REPAIRED IN INFANCY. SUBSEQUENTLY, HE UNDERWENT DACRON PATCH REPAIR OF RECURRENT TRANSVERSE AORTIC ARCH OBSTRUCTION AND PLACEMENT OF A 14 MM HEMASHIELD DACRON JUMP GRAFT FROM THE ASCENDING AORTA TO THORACIC DESCENDING AORTA. THE PATIENT WAS LOST TO FOLLOW-UP FOR 10 YEARS. HE PRESENTED WITH CHEST PAIN, LOWER EXTREMITY CLAUDICATION, AND SEVERE UPPER EXTREMITY HYPERTENSION. ECHOGRAPHY AND CATHETERIZATION SHOWED THE DACRON JUMP GRAFT WAS PATENT AT ITS PROXIMAL TAKEOFF, BUT TORTUOUS AND SEVERELY STENOTIC AT ITS DISTAL INSERTION INTO THE THORACIC AORTA. A COVERED STENT WAS USED TO TREAT THE GRAFT STENOSIS. THE PATIENT HAD AN UNEVENTFUL RECOVERY.