PALADIN

Description of Event or Problem

IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE LEFT DISTAL COMMON CAROTID ARTERY USING THE PALADIN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IEP SYSTEM, THE PALADIN FILTER WOULD NOT OPEN. THE TARGET VESSEL DIAMETER WAS REPORTED AS 4MM, WITH MINIMAL TORTUOSITY AND SEVERE CALCIFICATION. AN 8FR NON-CONTEGO (PARAGON) BALLOON GUIDE CATHETER AND A NON-CONTEGO (STRYKER SYNCRO 14) GUIDEWIRE WERE USED. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE-DILATED WITH A 2MM EUPHORA BALLOON. THE VESSEL WAS POST-DILATED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEUROGUARD DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE DEVICE WAS INSIDE THE PATIENT WHEN THE FAILURE OCCURRED. FEMORAL ACCESS WAS GAINED WITH AN 8FR BALLOON GUIDE CATHETER. THE DEVICE WAS PREPPED ACCORDING TO THE IFU AND WHEN THE DEVICE WAS MOVED INTO PLACE THE FILTER WHEEL WAS TURNED TO OPEN. WHEN THE FILTER DID NOT OPEN THEY CLOSED THE WHEEL BACK DOWN AND TRIED AGAIN. THIS WAS ATTEMPTED THREE TIMES WITH NO CHANGE. PALADIN WAS PLANNED TO BE USED AS THE PRE-DILATION BALLOON PRIOR TO CAROTID STENTING PLANNED WITH NEUROGUARD. AFTER PALADIN FAILED, THEN THE 2MM BALLOON WAS USED FOR PRE-DILATION. POST-DILATION WAS PERFORMED WITH THE INTEGRATED NEUROGUARD BALLOON.

Additional Manufacturer Narrative

THE MANUFACTURER'S INVESTIGATION IS ONGOING. THIS REPORT IS BASED ON THE INFORMATION AVAILABLE AT THE TIME OF SUBMISSION. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT, AS REQUIRED.