Description of Event or Problem · 1
PATIENT CAME TO US WITH GANGRENE IN BOTH FEET. PERIPHERAL ANGIOGRAM ON THE RIGHT LEG SHOWED AN OCCLUDED ANTERIOR TIBIA, OCCLUDED PERONEAL ARTERY, AND AN OCCLUDED POSTERIOR TIBIA. ON THE LEFT LEG SHE HAD AN OCCLUDED ANTERIOR TIBIA, OCCLUDED PERONEAL, AND OCCLUDED POSTERIOR TIBIA. CARDIOLOGIST ATTEMPTED TO GET A CATHETER OR BALLOON DOWN, BUT COULD ONLY GET A WIRE THRU ANY OCCLUSIONS. HE ADVANCED A 1.25S PILOT ORBITAL ATHERECTOMY DEVICE (MADE BY CSI, CARDIOVASCULAR SYSTEMS INC)OVER THE WIRE AND TIRED ADVANCING IT BY ROTATING AT 60,000RPMS, THEN 90,000RPMS, THEN 120,000RPMS (ALL STANDARD OPERATING PROCEDURES FOR THE DEVICE). THE DEVICE WORKED FINE THE FIRST TWO TIMES, BUT ON THE THIRD, THE DEVICE TIP BROKE OFF AND REMAINED IN THE OCCLUDED VESSEL. SINCE THE TIP WASN'T GOING TO GO ANYWHERE WITH THE VESSEL OCCLUDED, HE ELECTED NOT TO TRY RETRIEVING IT WITH A VASCULAR RETRIEVAL DEVICE, OR A MICROSNARE, OR SEND THE PATIENT TO SURGERY TO RETRIEVE IT, SINCE ANY OF THOSE COULD BE MORE RISK THAN ANY BENEFIT. HE MANAGED TO STENT OTHER PORTIONS OF THE PATIENT'S PERIPHERAL ARTERIES AND HOPEFULLY THAT WOULD GIVE THE PATIENT SOME ADDED FLOW, BUT HE WASN'T HOPEFUL THAT THE PATIENT'S NON-HEALING ULCERS WOULD HEAL, NOR WAS HE HOPEFUL THAT ANY AMPUTATIONS WOULD HEAL EITHER. PATIENT AND FAMILY WERE AGAINST ANY AMPUTATIONS, SO THE PATIENT MOST LIKELY WOULD BE REFERRED TO HOSPICE AS THE GANGRENE PROGRESSED. IF THE PATIENT DID AGREE TO AMPUTATIONS, THEN THE FOREIGN BODY COULD BE REMOVED, BUT IT REALLY WAS DOING THE PATIENT NO HARM. THE PORTION OF THE VESSEL WHERE THE DEVICE TIP RESIDES REMAINS OCCLUDED, SO THE PIECE OF THE DEVICE IS UNLIKELY TO CAUSE THE PATIENT ANY HARM.======================MANUFACTURER RESPONSE FOR STEALTH 360, PILOT (PER SITE REPORTER).======================REQUESTED MR INFORMATION, COPY OF THE STUDY AND RETURN OF EQUIPMENT INVOLVED.======================MANUFACTURER RESPONSE FOR WIRE, VIPERWIRE ADVANCE GUIDEWIRE (PER SITE REPORTER).======================RETURN DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REESTABLISH CIRCULATION THROUGH OCCLUDED ARTERIES.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.