CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 3003742446-2011-00387
Event Type: Injury
Date Received: August 16, 2011
Date of Event: May 20, 2010
Report Date: July 21, 2011
Manufacturer: CORDIS LLC (PR)
Product Code: NIQ
PMA / PMN Number: P020026
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE REPORT RECEIVED FROM THE PATIENT VIA MEDICAL AFFAIRS INDICATED THAT APPROXIMATELY 5 YEARS AFTER PCI IN THE LEFT ANTERIOR DESCENDING ARTERY WITH 2 CYPHER STENTS, RE-PCI WAS PERFORMED IN THE LAD DUE TO IN-STENT RESTENOSIS WITH AN ENDEAVOR STENT FOR TREATMENT OF A HEART ATTACK. THIS (B)(6) MALE PATIENT WITH KNOWN HISTORY OF CORONARY ARTERY DISEASE AND PREVIOUS PCI AND STENTING, DIABETES MELLITUS, HYPERTENSION, AND HYPERLIPIDEMIA HAD ONGOING SEVERE EPISODES OF ANGINA. THE PATIENT REPORTED TO HAVE TWO CYPHER STENTS IMPLANTED IN THE LAD FOR 98% BLOCKAGE. APPROXIMATELY 10 MONTHS LATER, THE PATIENT REPORTS TO HAVE HAD A TAXUS STENT IN THE RCA FOR CHEST PAIN. TWO YEARS LATER, THE PATIENT REPORTED TO HAVE 2 MEDTRONIC STENTS IMPLANTED. MEDICAL RECORDS RECEIVED FROM THE PATIENT'S CARDIOLOGISTS INDICATE THAT THE PATIENT HAD A CARDIAC CATHETERIZATION WHICH REVEALED AN UNKNOWN PATENT STENT IN THE PROXIMAL TO MID LAD, MILD DISEASE IN THE DIAGONAL BRANCH, MILD DISEASE IN THE PROXIMAL CIRCUMFLEX, AND A DOMINANT RCA WIDELY PATENT. THE EJECTION FRACTION WAS 55%. NO PCI WAS PERFORMED AND AGGRESSIVE MEDICAL MANAGEMENT AND RISK FACTOR MODIFICATION WAS IMPLEMENTED. APPROXIMATELY 10 YEARS LATER, THE PATIENT PRESENTED WITH TYPICAL ANGINA PECTORIS AND ANGIOGRAPHY WAS PERFORMED. THERE WAS 90% IN-STENT RESTENOSIS NOTED IN THE MID LAD AFTER THE TAKEOFF OF THE DIAGONAL BRANCH. THERE WAS MILD OSTIAL DISEASE IN THE DIAGONAL BRANCH. THERE WAS 20-30% STENOSIS IN THE PROXIMAL CIRCUMFLEX, 20% STENOSIS IN THE PROXIMAL RCA, PATENT STENT IN THE MID RCA, 90% STENOSIS IN THE PROXIMAL PLA. EJECTION FRACTION WAS 60%. BASED ON THIS FINDINGS, PCI WAS CONDUCTED TO TREAT THE IN-STENT RESTENOSIS IN THE LAD AND THE 90% STENOSIS IN THE RIGHT PLA. THE SEVERE STENOSIS OF THE PROXIMAL TO MID LAD IN-STENT RESTENOSIS WAS TREATED WITH THE IMPLANTATION OF A 2.5X24MM ENDEAVOR STENT. THE SECOND DIAGONAL WAS DILATED WITH A VOYAGER BALLOON ACHIEVING EXCELLENT RESULTS. THE LESION IN THE RIGHT PLA WAS TREATED WITH THE IMPLANTATION OF A 3.0X12MM ENDEAVOR STENT. 0% RESIDUAL STENOSIS AND TIMI 3 FLOW WAS OBTAINED IN BOTH TREATED VESSELS. APPROXIMATELY A YEAR LATER, THE PATIENT EXPERIENCED ONGOING CHEST PAIN. ANGIOGRAPHY REVEALED MILD DISEASE IN THE PROXIMAL CIRCUMFLEX, MINIMAL IN-STENT RESTENOSIS IN THE STENT IMPLANTED IN THE PROXIMAL LAD, 20% STENOSIS IN THE PROXIMAL RCA, AND MILD DISEASE IN THE RIGHT PLA. THE EJECTION FRACTION WAS 60%. NO PCI WAS CONDUCTED AND MEDICAL MANAGEMENT WAS ADVISED. MEDICAL RECORDS DETAILING CYPHER STENT IMPLANTATION WERE NOT AVAILABLE. THERE WAS NO EVIDENCE IN THE MEDICAL RECORDS PROVIDED THAT THE PATIENT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS FOLLOWING STENT IMPLANTATION AND ARE OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS (SPECIFICALLY DIABETES) THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT AND MYOCARDIAL INFARCTION. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 3003742446-2011-00386 AND 3003742446-2011-00387.

Additional Manufacturer Narrative · 1

THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 3003742446-2011-00386 AND 3003742446-2011-00387.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT REGARDING THE PATIENT'S INTERVENTION FOR IN-STENT RESTENOSIS ON (B)(6) 2010, POST PERCUTANEOUS CORONARY INTERVENTION TO THE LAD WITH AN ENDEAVOR STENT, PLAIN OLD BALLOON ANGIOPLASTY TO DIAGONAL, AND PERCUTANEOUS CORONARY INTERVENTION WITH STENTING TO POSTEROLATERAL ARTERY WITH ANOTHER ENDEAVOR DRUG-ELUTING STENT. THE PATIENT'S CONDITION AT DISCHARGE WAS STABLE AND DENIED ANY CHEST PAIN OR SHORTNESS OF BREATH. THE POST-PROCEDURE MEDICATIONS WERE AS FOLLOWS: ASPIRIN 325MG DAILY, PLAVIX 75 MG DAILY, NEURONTIN 600 TWICE A DAY, TOPROL XL 50 MG TWICE A DAY, SINGULAIR, ZOCOR 40 MG AT BEDTIME, DIOVAN 320 MG A DAY, PROTONIX 40 MG A DAY, TRAMADOL 50 MG 4 X DAY, NITROGLYCERIN 0.5 AS NEEDED, ALBUTEROL AS NEEDED, LEVOTHYROXINE 50 MCG DAILY, BUDESONIDE WITH FORMAL INHALERS TWICE A DAY, METFORMIN 500 TWICE A DAY TO BE STARTED 48 HOURS AFTER PROCEDURE. APPROXIMATELY 1 YEAR FOLLOWING THE INITIAL PROCEDURE ((B)(6) 2006), THE PATIENT PRESENTED WITH PROGRESSIVE ANGINA PECTORIS, KNOWN CORONARY ARTERY DISEASE WITH RECENT PCI AND STENTING WITH ONGOING SEVERE EPISODES. ANGIOGRAPHY REVEALED A WIDELY PATENT STENT WITH MODERATE TO MILD DISEASE IN THE DIAGONAL BRANCH. RECORDS RECEIVED OF A SUBSEQUENT CARDIAC CATHETERIZATION ON (B)(6) 2011 REVEALED THE PATIENT PRESENTED WITH ONGOING CHEST PAIN WITH THE RESULTS OF THE EVALUATION SHOWING A PATENT STENT WITH MINIMAL IN-STENT RESTENOSIS. HOWEVER, THE PHYSICIANS' IMPRESSION/PLAN AT THE END OF THE PROCEDURE INDICATED A PATENT STENT IN THE PROXIMAL LAD. THE PATIENT WAS CONTINUED ON MAXIMAL MEDICAL MANAGEMENT. HE WAS STARTED ON IMDUR 60 MG ONCE A DAY. PLEASE NOTE THAT ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 3003742446-2011-00386 AND 3003742446-2011-00387.

Description of Event or Problem · 1

THE REPORT RECEIVED FROM THE PATIENT VIA MEDICAL AFFAIRS INDICATED THAT APPROXIMATELY 5 YEARS AFTER PCI IN THE LEFT ANTERIOR DESCENDING ARTERY WITH 2 CYPHER STENTS, RE-PCI WAS PERFORMED IN THE LAD DUE TO IN-STENT RESTENOSIS WITH AN ENDEAVOR STENT DUE TO IN-STENT RESTENOSIS WITH AN ENDEAVOR STENT FOR TREATMENT OF A HEART ATTACK. THE PATIENT ALSO HAD PLAIN OLD BALLOON ANGIOGPLASTY IN THE DIAGONAL AND PCI WITH STENTING TO THE POSTEROLATERAL ARTERY WITH ANOTHER ENDEAVOR DRUG-ELUTING STENT. THE PATIENT WAS DISCHARGED ONE DAY LATER. IN A PREVIOUS REPORT FILED APPROXIMATELY 12 MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT REPORTING HAVING HAD A RECENT ANGIOGRAM AND HAD A STENT (TAXUS) STENT WAS IMPLANTED ON RIGHT SIDE. PATIENT SAID THAT DURING THIS LAST CATH, DOCTORS TOLD HIM THAT THE STENTS "WERE DETERIORATING." HE WAS REFERRED TO A CARDIOVASCULAR SURGEON. APPROXIMATELY 5 YEARS LATER, THE PATIENT CALLED "REQUESTING INFORMATION REGARDING RECALLED CYPHER STENTS, AND ADDITIONALLY REPORTED ADVERSE EVENTS. ON (B)(6) 2006 PATIENT HAD A ONE TO TWO DAY INPATIENT HOSPITALIZATION AND A TAXUS STENT PLACED IN RCA FOR "CHEST PAIN." TREATMENT REPORTED WAS NITROGLYCERINE TRANSDERMAL PATCH 0.8 MG/HR. EVENT HAS NOT RESOLVED. BEGINNING 2008-U-U PATIENT EXPERIENCED HYPOTHYROIDISM. TREATMENT REPORTED WAS LEVOTHYROXINE 50 MCG DAILY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CYPHER SIROLIMUS-ELUTING CORONARY STENT	DRUG-ELUTING STENT (NIQ)	NIQ	CORDIS LLC (PR)	NA	A0405744

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Hospitalization\| L\| R	ENDEAVOR STENT