AMPLATZER DUCT OCCLUDER

Additional Manufacturer Narrative

THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

Description of Event or Problem

THE ARTICLE, "TRANSCATHETER CLOSURE OF A POSTOPERATIVE LEFT VENTRICULAR PSEUDOANEURYSM USING A DUCT OCCLUDER IN A HIGH-RISK PATIENT", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF AN 83-YEAR-OLD PATIENT WITH A HISTORY OF ASCENDING THORACIC AORTIC ANEURYSM, SEVERE AORTIC REGURGITATION, POSTERIOR LEFT VENTRICULAR WALL TEAR, AND ASCENDING AORTA AND AORTIC VALVE REPLACEMENT. ON AN UNKNOWN DATE A "6-6MM" AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR LEFT VENTRICULAR PSEUDOANEURYSM IMPLANT. THE DEVICE WAS IMPLANTED. POST-IMPLANT MINIMAL RESIDUAL SHUNTING WAS OBSERVED. THE PATIENT WAS DISCHARGED. AT 3-MONTHS FOLLOW-UP COMPUTED TOMOGRAPHY DEMONSTRATED STABLE DEVICE POSITIONING WITH NO SIGNIFICANT RESIDUAL COMMUNICATION. [THE PRIMARY AND CORRESPONDING AUTHOR WAS AUGUSTIN TCHASSEM DIMDIE, CLINIQUE SUD LUXEMBOURG, VIVALIA, ARLON, BELGIUM, WITH CORRESPONDING E-MAIL: AUGUSTIN.TCHASSEM.DIMDIE@ULB.BE.]