CYPHER SIROLIMUS-ELUTING CORONARY STENT

Report

Report Number: 3003742446-2011-00208
Event Type: Injury
Date Received: April 27, 2011
Date of Event: August 26, 2010
Report Date: March 31, 2010
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

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

Additional Manufacturer Narrative · 1

A 2.0 X 12MM BALLOON CATHETER WAS USED DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00208 AND 3003742446-2011-00389. A PATIENT ENROLLED IN THE (B)(4) STUDY EXPERIENCED RESTENOSIS AND MYOCARDIAL INFARCTION POST IMPLANTATION OF SEVERAL CYPHER STENTS. THE PATIENT'S MEDICAL HISTORY INCLUDES: HISTORY OF ANGINA, POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA, PREVIOUS PCI, HISTORY OF CORONARY ARTERY DISEASE, UNSTABLE ANGINA PECTORIS, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, DIABETES MELLITUS TYPE II, ALLERGY TO PENICILLIN AND ALLERGY TO CODEINE. INITIALLY, A LESION IN THE DISTAL RIGHT CORONARY ARTERY WAS TREATED. THE LESION WAS 20MM IN LENGTH AND 2.25MM IN DIAMETER. THE LESION WAS PRE-DILATED AT 12ATM. A 2.25 X 23MM CYPHER STENT WAS IMPLANTED AT 11ATM. FIVE DAYS POST INDEX PROCEDURE, THE PATIENT REPORTED SEVERE SUBSTERNAL CHEST PAIN RADIATING TO THE LEFT SHOULDER. THE PATIENT HAD A 2.25 X 13MM CYPHER STENT IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING BRANCH. ANGIOGRAPHY REVEALED THAT THE STENT IMPLANTED DURING THE INDEX PROCEDURE WAS PATENT. APPROXIMATELY TWENTY TWO DAYS LATER, THE PATIENT REPORTED ATYPICAL CHEST PAIN WHICH WAS MEDICALLY MANAGED. ANGIOGRAPHY WAS NOT CONDUCTED. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT HAD CHEST PAIN. A NEW LESION, IN THE OBTUSE MARGINAL BRANCH, WAS DISCOVERED. THIS LESION WAS TREATED WITH A XIENCE STENT. IT WAS CONFIRMED THAT THE OTHER STENTS IMPLANTED PRIOR TO THIS EVENT WERE PATENT. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT THEN RETURNED WITH ANGINA. THE PATIENT WAS NOTED TO HAVE SEVERE, 99% ,STENOSIS AT THE PROXIMAL EDGE OF THE STENT THE CYPHER (CXS13225) STENT THAT HAD BEEN INITIALLY IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE OTHER STENTS WERE NOTED TO BE PATENT. APPROXIMATELY ELEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH CHEST PAIN. THE LESION IN THE OBTUSE MARGINAL PREVIOUSLY TREATED WITH A XIENCE STENT WAS REVASCULARIZED. ADDITIONAL INFORMATION THAT WAS RECEIVED INDICATED THAT THE PATIENT HAD A 2.5X13MM CYPHER STENT IMPLANTED PRIOR TO THE INDEX PROCEDURE IN THE OBTUSE MARGINAL BRANCH. THE CYPHER RESTENOSED ABOUT A YEAR AND A HALF LATER, AND WAS TREATED WITH A 2.5 X 14MM ENDEAVOR STENT. APPROXIMATELY SIX MONTHS LATER, THAT STENT HAD RESTENOSIS AND THE PATIENT HAD A MYOCARDIAL INFARCTION. THE PATIENT WAS TREATED WITH A 2.5 X 8MM XIENCE STENT. APPROXIMATELY SEVEN MONTHS LATER, THE PATIENT HAD RESTENOSIS ONCE AGAIN AND HAD A CORONARY ARTERY BYPASS GRAFT. 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 IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. MYOCARDIAL INFARCTIONS ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. 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) AND VESSEL/LESION FACTORS (SMALL VESSEL DIAMETER, MULTIPLE STENTS, RESTENOTIC LESIONS) THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. 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.

Additional Manufacturer Narrative · 1

THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00208 AND 3003742446-2011-00389. THE ADJUDICATION MINUTES THAT WERE RECEIVED ON (B)(6) 2011 INDICATED THAT THERE WAS 70% STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY AND ANGIOGRAPHIC CORE LAB REPORTED 17% IN-LESION RESTENOSIS, WITH NO THROMBUS, IN THE DISTAL RIGHT CORONARY ARTERY. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PERCUTANEOUS INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, DIABETES AND ALLERGIES TO CODEINE AND PENICILLIN. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. THE DISTAL RIGHT CORONARY ARTERY WAS TREATED DURING THE INDEX WITH A 2.25MM X 23MM CYPHER STENT. FIVE DAYS POST INDEX PROCEDURE, THE PATIENT REPORTED SEVERE SUBSTERNAL CHEST PAIN RADIATING TO THE LEFT SHOULDER. THE PATIENT HAD A 2.25 X 13MM CYPHER STENT IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING BRANCH. ANGIOGRAPHY REVEALED THAT THE STENT IMPLANTED DURING THE INDEX PROCEDURE WAS PATENT. APPROXIMATELY TWENTY TWO DAYS LATER, THE PATIENT REPORTED ATYPICAL CHEST PAIN WHICH WAS MEDICALLY MANAGED. ANGIOGRAPHY WAS NOT CONDUCTED. APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE, THE PATIENT HAD CHEST PAIN. A NEW LESION, IN THE OBTUSE MARGINAL BRANCH, WAS DISCOVERED. THIS LESION WAS TREATED WITH A XIENCE STENT. IT WAS CONFIRMED THAT THE OTHER STENTS IMPLANTED PRIOR TO THIS EVENT WERE PATENT. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT THEN RETURNED WITH ANGINA. THE PATIENT WAS NOTED TO HAVE SEVERE, 99%, STENOSIS AT THE PROXIMAL EDGE OF THE STENT THE CYPHER STENT THAT HAD BEEN INITIALLY IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE OTHER STENTS WERE NOTED TO BE PATENT. APPROXIMATELY ELEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED WITH CHEST PAIN. A LESION IN THE OBTUSE MARGINAL WAS REVASCULARIZED. OF NOTE, THIS LESION HAD BEEN PREVIOUSLY TREATED WITH A XIENCE STENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. RISK FACTORS FOR RESTENOSIS INCLUDE DIABETES, HYPERTENSION, LESIONS WITH A SMALL LUMEN AND LONG LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT PATIENT AND/OR LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

Additional Manufacturer Narrative · 1

IN THE PREVIOUS SUPPLEMENTAL MDR REPORT, IT WAS STATED THAT ADDITIONAL INFORMATION WOULD BE SUBMITTED WITHIN 30 DAYS OF RECEIPT, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00208 AND 3003742446-2011-00389.

Description of Event or Problem · 1

FIVE DAYS POST INDEX PROCEDURE, THE PATIENT REPORTED SEVERE SUBSTERNAL CHEST PAIN RADIATING TO THE LEFT SHOULDER. THE PATIENT HAD A 2.25 X 13MM CYPHER STENT IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING BRANCH. ANGIOGRAPHY REVEALED THAT THE STENT IMPLANTED DURING THE INDEX PROCEDURE WAS PATENT. APPROXIMATELY TWENTY TWO DAYS LATER, THE PATIENT REPORTED ATYPICAL CHEST PAIN WHICH WAS MEDICALLY MANAGED. ANGIOGRAPHY WAS NOT CONDUCTED. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT THEN RETURNED WITH ANGINA. THE PATIENT WAS NOTED TO HAVE SEVERE, 99% ,STENOSIS AT THE PROXIMAL EDGE OF THE STENT THE CYPHER (B)(4) STENT THAT HAD BEEN INITIALLY IMPLANTED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE OTHER STENTS WERE NOTED TO BE PATENT. THE PATIENT ENROLLED IN (B)(4) STUDY WITH A LESION IN THE DISTAL RIGHT CORONARY ARTERY. THE LESION WAS 20MM IN LENGTH AND 2.25MM IN DIAMETER. THE LESION WAS PRE-DILATED AT 12ATM. A 2.25 X 23MM CYPHER STENT WAS IMPLANTED AT 11ATM.

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	15077891

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR		Required Intervention