Description of Event or Problem · 1
SAME CASE AS MANUFACTURER'S REPORT NUMBERS; 6000093-2006-00334, 6000093-2006-00335,6000093-2006-00348 1 DAY AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A THROMBOSIS. THE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) AND DIAGONAL BRANCH (DIAG) CORONARY ARTERIES. TOTAL OCCLUSION WAS FOUND IN THE PROXIMAL LAD. ATTEMPTS TO CROSS THE TOTAL OCCLUSION WITH AN ASSAHI PROWATER FLEX GUIDEWIRE WERE UNSUCCESSFUL. THIS WIRE WAS EXCHANGED FOR AN ASHAI MIRACLE BROTHERS 3 GUIDEWIRE WITH SUPPORT OF A 2.5X20 MM MAVERICK BALLOON. THE MIRACLE BROTHERS 3 GUIDEWIRE WAS ADVANCED INTO THE DISTAL LAD. THE WIRE WAS EXCHANGED FOR AN ASAHI PROWATER FLEX GUIDEWIRE. AN ANGIOJET THROMBECTOMY WAS PERFORMED IN THE LAD IN A PROXIMAL TO DISTAL FASHION FOLLOWED BY A RUN IN A DISTAL TO PROXIMAL FASHION. THE DIAG LESION WAS PREDILATED USING A 2.5X20 MM MAVERICK BALLOON AT 3 ATMOSPHERES FOR 10 SECONDS. A REPEAT ANGIOGRAPHY DEMONSTRATED A SPIRAL DISSECTION IN THE DIAG BRANCH. A 2.5X24 MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE LAD AND EXTENDED INTO THE DIAG BRANCH. A 2.5X16 MM TAXUS EXPRESS2 WAS DEPLOYED IN THE MID DIAG - OVERLAPPING THE PREVIOUSLY PLACED STENT. A 2.5X15 MM SPRINTER BALLOON WAS ADVANCED INTO THE LAD. THE BALLOON WAS INFLATED TO 4 ATMOSPHERES FOR 10 SECONDS AND CRUSHED THE EXTENDING PORTITON OF THE TAXUS EXPRESS2 STENT IN THE LAD AGAINST THE WALL. A 3.5X16MM TAXUS EXPRESS2 STENT WAS DEPLOYED IN THE PROXIMAL PORTION OF THE LAD AT 14 ATMOSPHERES FOR 15 SECONDS. THE LESION WAS POST-DILATED WITH A 1.5 X 20 MM SPRINTER BALLOON IN THE DIAG AT 10 ATMOSPHERES FOR 10 SECONDS; THEN REPOSITIONED AND INFLATED 20 ATMOSPHERES FOR 10 SECONDS. A 2.5X15MM SPRINTER BALLOON WAS PLACED IN THE DIAG BRANCH AND THE BALLOON WAS INFLATED TO 20 ATOMOSPHERES FOR 10 SECONDS. SUBSEQUENTLY, A 3.75X15MM MAVERICK BALLOON WAS ADVANCED INTO THE LAD AND INFLATED TO 14 ATMOSPHERES FOR 10 SECONDS. REPEAT ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED REDUCTION OF THE LESION TO LESS THAN 0% RESIDUAL AND TIMI 3 FLOW IN BOTH VESSELS. THE PATIENT TOLERATED THE PROCEDURE WELL. HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN STABLE CONDITION. HE WAS GIVEN ASPIRIN, PLAVIX, AND REOPRO POST-PROCEDURE. THE PATIENT PRESENTED 1 DAY AFTER THE ORIGINAL INTERVENTION. THE PROXIMAL LAD WAS NOTED TO BE TOTALLY OCCLUDED. AN INTRAVASCULAR ULTRASOUND OF THE LAD AND DIAG BRANCHES DEMONSTRATED PATENT STENTS IN THE LAD WITH A DISSECTION IN THE PROXIMAL PORTION OF THE LAD. IN THE DIAG BRANCH, THE STENTS WERE SEEN TO BE PATENT, BUT THE POXIMAL DIAG STENT APPEARED TO BE INSUFFICIENTLY DEPLOYED. RE-ESTABLISHMENT OF TIMI3 FLOW WAS ACHIEVED AFTER ANGIOJET THROMBECTOMY AND COMPLEX PERCUTANEOUS CORONARY INTERVENTION WITH TWO-WIRE TECHNIQUE AND KISSING BALLOONS IN THE LAD. PLACEMENT OF A 3.5 X12 MM TAXUS STENT IN THE PROXIMAL PORTION OF THE LAD WAS FOLLOWED BY FINAL KISSING BALLOON DILATATIONS WITH A 3.0X15 MM BALLOON IN THE DIAG AND A 3.5 X 15 MM BALLOON IN THE LAD. THE PATIENT TOLERATED THE PROCEDURE WELL. HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT IN FAIR CONDITION . HE WAS GIVEN ASPIRIN AND PLAVIX LONG-TERM WITH DOULBLE-DOSE PLAVIX OF 150 MG FOR 1 MONTH.