Description of Event or Problem · 1
SAME CASE AS MFR REPORT #2134265-2008-00483. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. THE 90% STENOSED, CALCIFIED, TARGET LESION WAS IN THE EXTREMELY TORTUOUS LEFT CIRCUMFLEX (CX) AND "HIGH LATERAL" (HL) (CASS SITE #28) ARTERIES. THE PHYSICIAN SELECTED AND ATTEMPTED TO ADVANCE A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) BUT THE DEVICE WOULD NOT CROSS. AN ATLANTIS INTRAVASCULAR ULTRASOUND (IVUS) WAS UNABLE TO CROSS THE HL LESION. THE LESION WAS PREDILATED WITH A 2.5X15MM QUANTUM MAVERICK BALLOON AND THE PROXIMAL CX WAS PREDILATED WITH A 3.5X15MM QUANTUM MAVERICK BALLOON. THE 2.5X24MM TAXUS EXPRESS2 DES WAS RETRIED; HOWEVER, IT WAS STILL UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, RESISTANCE WAS ENCOUNTERED AND THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM ON THE UNK TYPE GUIDEWIRE. THE STENT WAS ABLE TO BE RETRIEVED WITH A SNARE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE ATLANTIS IVUS CATHETER AGAIN BUT IT REMAINED UNABLE TO CROSS THE LESION. THE 2.5X15MM QUANTUM MAVERICK BALLOON WAS REATTEMPTED, BUT CONTINUED TO BE UNABLE TO PASS ADEQUATELY. THE ATLANTIS IVUS CATHETER WAS ABLE TO BE ADVANCED INTO THE LEFT ANTERIOR DESCENDING ARTERY WHERE IT WAS DETERMINED THAT THE PREVIOUSLY IMPLANTED 3.5X32MM TAXUS EXPRESS2 DES APPEARED TO HAVE A STENT STRUT THAT EXTENDED INTO THE CX. THERE WAS EXTREME STENOSIS NOTED IN THE LEFT MAIN TRUNK WITH NO BACK FLOW. IVUS ALSO DETERMINED THAT THERE WAS UNSTABLE PLAQUE IN THE LMT. THE DECISION WAS MADE TO ABORT THE PERCUTANEOUS PROCEDURE AND SEND THE PT TO SURGERY. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".