ALPHAVAC

Additional Manufacturer Narrative

THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT EMBOLIZATION AND SUBSEQUENT EXPIRATION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). THERE WERE NO REPORTS OF ALPHAVAC DEVICE MALFUNCTION OR PERFORMANCE ISSUE DURING THE PROCEDURE; THEREFORE, THE DEVICE WAS NOT A CONTRIBUTING FACTOR TO THE PATIENT'S EXPIRATION. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE PACKAGING/ASSEMBLY LOTS COULD NOT BE PERFORMED SINCE THERE WAS NO REPORTED LOT NUMBER. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS PROVIDED WITH THIS DEVICE CONTAINS THE FOLLOWING STATEMENTS: INDICATIONS FOR USE THE CANNULA IS INDICATED FOR: THE NON-SURGICAL REMOVAL OF THROMBI OR EMBOLI FROM THE VENOUS VASCULATURE. ASPIRATION OF CONTRAST MEDIA AND OTHER FLUIDS FROM THE VENOUS VASCULATURE. THE CANNULA IS INTENDED FOR USE IN THE VENOUS SYSTEM AND FOR THE TREATMENT OF PULMONARY EMBOLISM. DIRECTIONS FOR USE AND MANUALS FOR THE ALPHAVAC SYSTEM AND ALL RELATED ACCESSORIES SHOULD BE READ PRIOR TO USE AND DEVICES USED AS INDICATED. AS WITH ALL MEDICAL DEVICES, THIS DEVICE AND ANCILLARY EQUIPMENT ARE TO BE USED BY TRAINED PHYSICIANS ONLY. SPECIFICALLY, THIS DEVICE IS TO BE USED ONLY BY MEDICAL PERSONNEL EXPERIENCED WITH USING SURGICAL AND/OR PERCUTANEOUS (SELDINGER) VASCULAR ACCESS TECHNIQUES AS WELL AS PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS, INTRAVASCULAR, DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES REQUIRING FLUOROSCOPIC OR IMAGE GUIDANCE AND VISUALIZATION. ADVERSE EVENTS: THIS DEVICE, AS DO ALL EMBOLECTOMY SYSTEMS AND DEVICES, HAS POSSIBLE SIDE EFFECTS, WHICH INCLUDE, BUT ARE NOT LIMITED TO INFECTIONS, BLOOD LOSS, THROMBUS FORMATION, EMBOLIC EVENTS, VESSEL, VENTRICULAR OR VALVULAR DAMAGE AND COMPLICATIONS OF PERCUTANEOUS OR SURGICAL INSERTION TECHNIQUES. THESE MAY OCCUR IF THE DIRECTIONS FOR USE ARE NOT FOLLOWED. POSSIBLE COMPLICATIONS INCLUDE THOSE NORMALLY ASSOCIATED WITH LARGE BORE SURGICAL AND/OR PERCUTANEOUS VESSEL CATHETERIZATION/CANNULATION, ANTICOAGULATION, AND APPLICATION OF INTRAVASCULAR INTRODUCER SYSTEMS WHICH INCLUDE BUT ARE NOT LIMITED TO: DISTAL EMBOLIZATION OF THROMBUS, PULMONARY EMBOLISM, CARDIAC ARREST, DEATH. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

Description of Event or Problem

AN ANGIODYNAMICS CLINICAL SPECIALIST MANAGER REPORTED THE FOLLOWING EVENT: "DR. (B)(6) CONTACTED OUR CLINICAL TEAM FOR VIRTUAL COVERAGE OF AN INCOMING PE PATIENT. KERRY-ANN WAS AVAILABLE AND RECEIVED INFORMATION FROM DR. (B)(6) STATING THAT THE PATIENT WAS YOUNG AND HAD RECENTLY HAD KNEE SURGERY. RIGHT HEART STRAIN WAS FOUND ON BEDSIDE ECHO, AND PATIENT HAD BEEN RESUSCITATED AT LEAST 3-4 TIMES SO FAR. TNK WAS GIVEN AND THE PATIENT WAS TRANSFERRED TO THE CATH LAB, WHERE DR. TOMA PROCEEDED WITH AN ALPHAVAC PE PROCEDURE. KERRY-ANN PROVIDED VIRTUAL INSTRUCTIONS FOR DEVICE ASSEMBLY AND HANDLE PULLS. THE PATIENT REQUIRED CPR 3 TIMES ON THE TABLE, AND THE DEVICE HAD TO BE PULLED OUT OF THE PAS. AFTER NO CLOT RETRIEVAL, AND SUSTAINED ASYSTOLE, DR. TOMA PROCEEDED TO TAKE A PA GRAM WITH A PIGTAIL CATHETER. IMAGING SHOWED NO CENTRAL CLOT BUT SCATTER PE WHICH WAS FATAL AND ALPHAVAC WOULD NOT BE USEFUL." IT WAS REPORTED THAT THE PATIENT WAS EXTREMELY UNSTABLE BEFORE THE PROCEDURE AND CPR HAD BEEN PERFORMED MANY TIMES. ONCE PROLONGED ASYSTOLE WAS PRESENT, THE PHYSICIAN TOOK IMAGES TO VISUALLY CONFIRM IF THE ALPHAVAC DEVICE WOULD MAKE ANY DIFFERENCE FOR THIS PATIENT AND IT WAS DETERMINED THAT IT WOULD NOT.