TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2134265-2014-01105
Event Type: Injury
Date Received: March 12, 2014
Date of Event: February 21, 2011
Report Date: February 13, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MDR ID: 2134265-2014-01098, 2134265-2014-01106 AND 2134265-2014-01107. (B)(4). IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) AND CHEST PAIN ASSOCIATED WITH NAUSEA, SHORTNESS OF BREATH AND DIAPHORESIS OCCURRED. IN (B)(6) 2010, AT THE START OF THE STUDY, THE SUBJECT RECEIVED THE STUDY MEDICATION MAINTENANCE DOSE OF 75 MG. ON AN UNKNOWN DATE, THE SUBJECT WAS STARTED ON ASPIRIN 325 MG. TWO DAYS AFTER, THE PATIENT PRESENTED DUE TO VENTRICULAR TACHYCARDIA, ELEVATED TROPONIN I, STABLE ANGINA AND SIGNIFICANT CORONARY ARTERY DISEASE. CARDIAC CATHETERIZATION WAS THEN RECOMMENDED. THE PATIENT WAS BROUGHT TO THE CARDIAC CATHETERIZATION LAB IN A FASTING AND NONSEDATED STATE. VASCULAR ACCESS WAS OBTAINED VIA RIGHT GROIN USING A 6F SHEATH UNDER FLUOROSCOPIC GUIDANCE WITHOUT ANY COMPLICATION HOWEVER, DIFFICULTY ADVANCING WAS NOTED DUE TO FIBROSIS. THE 98% TARGET LESION WAS AN IN-STENT RESTENOSIS OF AN UNSPECIFIED STENT LOCATED IN THE MID DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 6F NON-BSC CATHETER WAS USED TO PERFORM ANGIOGRAPHY IN THE LEFT CORONARY SYSTEM AND AN UNSPECIFIED IMAGING CATHETER TO PERFORM ANGIOGRAPHY IN THE TARGET LESIONS AND ANOTHER UNSPECIFIED MULTIPURPOSE CATHETER TO VISUALIZE THE AORTA TO RIGHT CORONARY ARTERY FOR LAST REVIEW. FOLLOWING THE DIAGNOSTIC ANGIOGRAM, A 6F UNSPECIFIED IMAGING CATHETER WAS ADVANCED HOWEVER WAS DIFFICULT TO ENGAGE. THE DEVICE WAS REPLACED WITH ANOTHER 6F IMAGING CATHETER BUT WAS NOT ABLE TO ENGAGE THE OSTIUM OF THE LIMA TO LAD GRAFT. A NON-BSC GUIDE WIRE WAS THEN ADVANCED TO CROSS THE LESION AND ANOTHER NON-BSC GUIDE WIRE TO CROSS THE DISTAL PART OF THE LESION. A 2MM APEX BALLOON CATHETER WAS ADVANCED TO PRE-DILATE THE ISR AREA. MULTIPLE BALLOON DILATATIONS WERE PERFORMED. THE PHYSICIAN TREATED THE ISR OF THE MID DISTAL LAD WITH DIRECT PLACEMENT USING 2.25 MM X 2.0 MM AND 2.25 MM X 12 MM TAXUS LIBERTE STENTS. POST-DILATATION WITH A BALLOON STENT WAS PERFORMED. DURING THE PROCEDURE, THE PATIENT WAS GIVEN INTRACORONARY NITROGLYCERIN TO RELIEVED THE CORONARY SPASM AND ALSO GIVEN ANGIOMAX. AT THE END OF THE PROCEDURE, RIGHT FEMORAL ANGIOGRAM WAS PERFORMED WITH A 6F NON-BSC DEVICE THROUGH THE RIGHT FEMORAL ARTERY WITHOUT ANY COMPLICATIONS. IN (B)(6) 2010, THE PATIENT PRESENTED WITH CHEST PAIN AND HAD NON-ST MYOCARDIAL INFARCTION. LEFT HEART CATHETERIZATION WAS THEN PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY UTILIZING A MODIFIED SELDINGER TECHNIQUE USING A 6F SHEATH. THE 99% STENOSED, FOCAL TARGET LESION WAS LOCATED IN THE DISTAL LAD. A 6F NON-BSC GUIDE CATHETER WAS ADVANCED OVER THE NON-BSC GUIDE WIRE TO THE AORTIC ROOT AND ENGAGED THE LEFT MAIN ARTERY AND MULTIPLE ANGIOGRAMS WERE OBTAINED. HEPARIN DRIP WAS ADMINISTERED. AFTER CROSSING THE DISTAL LAD USING A NON-BSC GUIDE WIRE, A 1.5MM X 12MM APEX BALLOON CATHETER WAS INFLATED AT 6 ATMOSPHERES FOR 180 SECONDS. A 2.25 X 8MM TAXUS ATOM STENT WAS THEN IMPLANTED AT 4 ATMOSPHERES FOR 20 SECONDS. POST-DILATION WAS PERFORMED USING A 2.5MM X 12MM QUANTUM APEX BALLOON CATHETER AT 4 ATMOSPHERES FOR 20 SECONDS AND ADDITIONAL DILATION WAS MADE USING A 2.5 X 15MM QUANTUM APEX BALLOON CATHETER AT 8 ATMOSPHERES FOR 20 SECONDS. THE 2.25MM X 12MM TAXUS ATOM STENT WAS THEN IMPLANTED PROXIMAL TO THE PREVIOUSLY PLACED STENT AND POST-DILATATION WITH A 2.5MM X 15MM APEX BALLOON CATHETER WAS PERFORMED AT 12 ATMOSPHERES FOR 30 SECONDS. FOLLOWING POST DILATATION, GOOD ANGIOGRAPHIC RESULT WAS OBTAINED WITH 0% RESIDUAL STENOSIS. THE PROCEDURE WAS COMPLETED WITH A 6F NON-BSC VASCULAR CLOSURE DEVICE AND THE PATIENT TOLERATED THE PROCEDURE WELL. IN (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN WITH AN INTENSITY OF 10/10 WHEN HE WAS WALKING FROM THE BATHROOM TO THE LIVING ROOM WHICH WAS REPORTED WITH THE SERIOUS CRITERIA OF HOSPITALIZATION. THE PATIENT DESCRIBED THE PAIN AS A PRESSURE OVER THE LEFT CHEST THAT RADIATED TO THE LEFT SHOULDER AND WAS ASSOCIATED WITH NAUSEA, SHORTNESS OF BREATH, AND DIAPHORESIS. THE CHEST PAIN DID NOT IMPROVE WITH NITROGLYCERIN SUBLINGUAL FOR 3 DOSES; THEREFORE, THE PATIENT WAS BROUGHT TO THE ER VIA EMS. THE FOLLOWING DAY, THE PATIENT HAD A CARDIAC CATHETERIZATION WHICH REVEALED OCCLUSION OF THE LAD POST ORIGIN OF THE FIRST DIAGONAL BRANCH, OCCLUSION OF THE LEFT CIRCUMFLEX POST ORIGIN OF THE FIRST OBTUSE MARGINAL, 99 % STENOSIS OF THE OSTIUM OF THE FIRST OBTUSE MARGINAL, SAPHENOUS VEIN GRAFT (SVG) TO POSTERIOR DESCENDING ARTERY (PDA) WITH MULTIPLE STENTS WITH MILD IN-STENT RESTENOSIS, 80 % TO 90 % STENOSIS WITHIN THE PDA AND LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD WAS PATENT. SUBSEQUENTLY, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) REVASCULARIZATION WITH REDUCTION OF THE 80 % - 90 % STENOSIS OF THE PDA TO 0 % WITH A PLACEMENT OF A DRUG ELUTING STENT. PCI OF THE OSTIAL FIRST OBTUSE MARGINAL WAS UNSUCCESSFUL. RECOMMENDATION WERE MADE TO CONTINUE THE SUBJECT ON ASPIRIN AND PLAVIX TO MAXIMIZE HIS ANTI-ANGINAS INCLUDING RANEXA, AND TO DO AGGRESSIVE MEDICAL TREATMENT FOR HIS CORONARY ARTERY DISEASE AS WELL AS A DIURETIC FOR HIS ELEVATED LEFT VENTRICULAR END-DIASTOLIC PRESSURE. TWO DAYS POST PROCEDURE,THE OUTCOME OF THE EVENT IS RECOVERED/ RESOLVED AND THE PATIENT WAS DISCHARGED HOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
146961	TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	UNK433

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Hospitalization\| R