Description of Event or Problem · 1
SAME CASE AS MFR REPORT #2134265-2008-00726 AND # 2134265-2008-00727. IT WAS REPORTED THAT DURING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, SHAFT FRACTURE AND STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS IN THE SEVERELY TORTUOUS AND HEAVILY CALCIFIED PROXIMAL TO DISTAL RIGHT CORONARY ARTERY (RCA). A NON-BSC GUIDE CATHETER AND A NON-BSC GUIDEWIRE WERE ADVANCED INTO THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN INCORPORATED THE 2 WIRE TECHNIQUE DURING THE PROCEDURE. THE LESION WAS PREDILATED WITH A 3.5X15MM NON-BSC BALLOON CATHETER. A 3.0X20MM TAXUS EXPRESS2 DRUG ELUTING STENT (DES) WAS ADVANCED BUT UNABLE TO CROSS THE PROXIMAL RCA. THE PHYSICIAN ADVANCED A NON-BSC ASPIRATION CATHETER TO THE TARGET LESION. THE ASPIRATION CATHETER WAS NOT USED TO REMOVE THROMBUS, BUT TO "HELP OUT" THE TAXUS EXPRESS2 STENT DELIVERY SYSTEM (SDS) BY CROSSING THE LESION FIRST. THE PHYSICIAN ATTEMPTED TO READVANCE TH 3.0X20MM TAXUS EXPRESS2 DES TO THE TARGET LESION, BUT IT WOULD NOT CROSS THE LESION COMPLETELY. DURING WITHDRAWAL, THE 3.0X20MM TAXUS EXPRESS2 DES BECAME CAUGHT ON THE NON-BSC ASPIRATION CATHETER. WHILE REMOVING THE WHOLE SYSTEM WAS REMOVED AS A UNIT, THE HYPOTUBE OF THE SDS FRACTURED IN THE GUIDE CATHETER. THE DEVICE WAS ABLE TO BE REMOVED SUCCESSFULLY WITH A SNARE AND IT WAS NOTICED THAT THE EDGE OF THE STENT APPEARED "LIFTED". THE NON-BSC ASPIRATION CATHETER WAS READVANCED TO THE TARGET LESION. A 3.0X32MM TAXUS EXPRESS2 DES WAS SUCCESSFULLY DEPLOYED IN THE DISTAL RCA. ANOTHER 3.0X20MM TAXUS EXPRESS2 DES WAS ADVANCED TO THE MID RCA WITH THE NON-BSC ASPIRATION CATHETER, BUT IT WOULD NOT CROSS THE LESION. AS A RESULT OF "PUSHING" THE DEVICE, THE HYPOTUBE FRACTURED. THE DEVICE WAS ABLE TO BE SUCCESSFULLY REMOVED. THE GUIDE CATHETER WAS RE-ENGAGED AS IT HAD "OFTEN BACK OUT" DURING THE PROCEDURE. THIS RESULTED IN UNSPECIFIED "DAMAGE" DURING THE PROCEDURE. THIS RESULTED IN UNSPECIFIED "DAMAGE" TO THE OSTIUM OF THE RCA. A 3.5X20MM TAXUS EXPRESS2 DES WAS SUCCESSFULLY DEPLOYED IN THE OSTIAL PORTION OF THE RCA. THE GUIDEWIRE AND NON-BSC ASPIRATION CATHETER WERE READVANCED. A 3.0X16MM TAXUS EXPRESS2 DES WAS DEPLOYED IN THE MID RCA OVERLAPPING THE 3.0 X 32MM TAXUS IN THE DISTAL RCA. A 3.5X16MM TAXUS EXPRESS DES WAS THEN ADVANCED ATTEMPTING TO OVERLAP THE 3.0X16MM TAXUS EXPRESS2 DES BUT IT WOULD NOT CROSS ADEQUATELY AND THE HYPOTUBE KINKED. THE NON-BSC ASPIRATION CATHETER WAS ADVANCED DISTALLY AND ANOTHER 3.5X16MM TAXUS EXPRESS2 DES WAS ADVANCED BUT CAUGHT ON THE 3.5X20MM TAXUS EXPRESS2 DES IMPLANTED IN THE OSTIUM OF THE RCA. THE DEVICE WAS REMOVED AND THE DECISION WAS MADE TO END THE PROCEDURE. INITIAL VISUAL EXAMINATION OF THE 3.5X16MM TAXUS EXPRESS2 DES SHOWED ONE HAD SUSTAINED A SHAFT FRACTURE AND OTHER HAD A SHAFT KINK. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THE PATIENT'S CURRENT CONDITION LISTED AS "GOOD".