BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3999967 · Received August 11, 2014

    Report

    Report Number
    3003742446-2014-00038
    Event Type
    Injury
    Date Received
    August 11, 2014
    Date of Event
    January 1, 2013
    Report Date
    July 20, 2014
    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

    IN DECEMBER 2007, HE RETURNED WITH UNSTABLE ANGINA THAT REQUIRED DEPLOYMENT OF A 2.5 X 18 MM CYPHER SIROLIMUS-ELUTING STENT TO TREAT THE OSTIUM OF THE SVG-D-OM BYPASS FOR THE FIRST EPISODE OF IN-STENT RESTENOSIS. IN APRIL 2008, THE PATIENT WAS READMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH THE SECOND EPISODE OF OSTIAL SVG-D-OM BYPASS GRAFT IN-STENT RESTENOSIS. FOR THIS EVENT, THE RESTENOSIS WAS TREATED WITH A 2.5 X 14 MM NON-CORDIS ZOTAROLIMUS-ELUTING STENT DEPLOYED AT 16 ATM FOR 25 SEC AND POSTDILATED AT 21 ATM FOR 30 SEC WITH 0% POSTPROCEDURE STENOSIS. IN LATE JUNE 2008, 85 DAYS AFTER THE APRIL 08 CORONARY INTERVENTION, THE PATIENT WAS READMITTED WITH RECURRENT CHEST PAIN AND A NON-ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION SHOWED PATENT LM AND CX STENTS AND TOTAL OCCLUSION OF THE OSTIUM OF THE SVG-D-OM BYPASS WITH EVIDENCE OF PROXIMAL STENT FRACTURE OF THE NON-CORDIS ZOTAROLIMUS-ELUTING STENT IN A HIGHLY DYNAMIC PORTION OF THE VESSEL. CORONARY ANGIOPLASTY WAS PERFORMED WITH A 1.5X 6 MM NON-CORDIS BALLOON, WHICH WAS INFLATED AT 12 ATM TO DILATE THE AREA OF IN-STENT RESTENOSIS DISTAL TO THE STENT FRACTURE. A 2.5 X 12 MM NON-CORDIS BALLOON WAS THEN INFLATED AT 10 ATM. THE PROXIMAL SEGMENT OF THE FRACTURED STENT REMAINED AROUND THE BALLOON CATHETER JUST PROXIMAL TO THE BALLOON. THE BALLOON WAS INFLATED AT LOW PRESSURE TO SECURE THE SMALL PROXIMAL SEGMENT OF THE NON-CORDIS FRACTURED STENT. THE GUIDEWIRE, BALLOON, AND GUIDING CATHETER WERE THEN PULLED OUT TOGETHER WITH RESTORATION OF THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 3 FLOW IN THE BYPASS GRAFT. THE PROXIMAL PORTION OF THE FRACTURED STENT, HOWEVER, DISLODGED AT THE FEMORAL ARTERY SHEATH LEVEL. VASCULAR SURGERY EVALUATION LOCATED THE SEPARATED NON-CORDIS STENT FRAGMENT IN A BRANCH OF THE RIGHT FEMORAL PROFUNDIS ARTERY. INTRAOPERATIVE ARTERIOGRAM SHOWED GOOD PERFUSION OF THE RIGHT SUPERFICIAL FEMORAL AND FEMORAL PROFUNDIS ARTERIES, THEREFORE, THE STENT FRAGMENT WAS LEFT IN THE FEMORAL PROFUNDIS BRANCH. THE PATIENT RECOVERED WITHOUT ANY UNTOWARD CARDIAC OR VASCULAR EVENTS AND WAS DISCHARGED 2 DAYS LATER. IT IS NOTEWORTHY THAT THE PATIENT HAD BEEN TREATED WITH AN APPROPRIATE MEDICAL REGIMEN FROM 2004 UNTIL THE JUNE 2008 ADMISSION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE IT IS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: VENERO ET AL (2013). A COMPLETELY FRACTURED ZOTAROLIMUS-ELUTING STENT IN AN AORTOCORONARY SAPHENOUS VEIN BYPASS GRAFT. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 81, 62-65. THE CATALOG CODE PROVIDED (CYPHER), REPRESENTS AN UNKNOWN US CYPHER STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. PLEASE NOTE THAT THE EVENT DATE (JANUARY 1, 2013) WAS PROVIDED INCORRECTLY IN ORDER TO MEET ELECTRONIC MEDWATCH ACCEPTANCE REQUIREMENTS. IT IS ONLY KNOWN THAT THE ARTICLE WAS PUBLISHED IN 2013; THE MONTH AND DAY IS CURRENTLY UNKNOWN. PLEASE NOTE THAT THE IMPLANT DATE (MAY 1, 2004) WAS PROVIDED INCORRECTLY IN ORDER TO MEET ELECTRONIC MEDWATCH ACCEPTANCE REQUIREMENTS. IT IS ONLY KNOWN THAT THE EVENT OCCURRED ON MAY 2004; THE DAY IS CURRENTLY UNKNOWN. CONCOMITANT MEDICATIONS: ASPIRIN, CLOPIDOGREL, SIMVASTATIN, EXTENDED RELEASE NIACIN, METOPROLOL SUCCINATE, BENAZEPRIL, GLIPIZIDE, REPAGLINIDE, PIOGLITAZONE, AND INSULIN. CONCOMITANT DEVICES: 2.5X18 MM CYPHER STENT, 2 UNKNOWN CYPHER STENTS, AND AN ENDEAVORVR ZOTAROLIMUS-ELUTING STENT (MEDTRONIC, MINNEAPOLIS, MN). THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS IN THIS ARTICLE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2014-00037, 3003742446-2014-00038, 3003742446-2014-00039, AND 3003742446-2014-00040.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS IN THIS ARTICLE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2014-00037, 3003742446-2014-00038, 3003742446-2014-00039, AND 3003742446-2014-00040. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY VENERO ET AL A COMPLETELY FRACTURED ZOTAROLIMUS-ELUTING STENT IN AN AORTOCORONARY SAPHENOUS VEIN BYPASS GRAFT, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 81 (2013) 62-65; THE PATIENT WAS TREATED WITH 3 CYPHER SIROLIMUS-ELUTING STENTS, ONE OF WHICH WAS A 2.5 X 8 MM CYPHER SIROLIMUS-ELUTING STENT TO THE OSTIUM OF THE SVG-D-OM BYPASS. APPROXIMATELY 3 YEARS LATER, HE RETURNED WITH UNSTABLE ANGINA THAT REQUIRED DEPLOYMENT OF A 2.5 X18 MM CYPHER, SIROLIMUS-ELUTING STENT TO TREAT THE OSTIUM OF THE SVG-D-OM BYPASS FOR THE FIRST EPISODE OF IN-STENT RESTENOSIS. APPROXIMATELY ONE YEAR LATER, THE PATIENT WAS READMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH THE SECOND EPISODE OF OSTIAL SVG-D-OM BYPASS GRAFT IN-STENT RESTENOSIS. FOR THIS EVENT, THE RESTENOSIS WAS TREATED WITH A 2.5 X 14 MM NON-CORDIS ZOTAROLIMUS-ELUTING STENT. EIGHTY-FIVE (85) DAYS AFTER THE (B)(6) CORONARY INTERVENTION, THE PATIENT WAS READMITTED WITH RECURRENT CHEST PAIN AND A NON-ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION SHOWED PATENT LM AND CX STENTS AND TOTAL OCCLUSION OF THE OSTIUM OF THE SVG-D-OM BYPASS WITH EVIDENCE OF PROXIMAL STENT FRACTURE OF THE NON-CORDIS ZOTAROLIMUS-ELUTING STENT. BETWEEN 2001 AND 2004, THE PATIENT HAD SEVERAL ADMISSIONS FOR UNSTABLE ANGINA FOR WHICH HE REQUIRED MULTIPLE PERCUTANEOUS CORONARY INTERVENTIONS (PCI) TO THE BYPASS GRAFTS. IN (B)(6) 2004, THE PATIENT UNDERWENT RE-DO CABG WITH LEFT INTERNAL MAMMARY ARTERY BYPASS TO THE LAD, SEQUENTIAL SVG BYPASS TO THE DIAGONAL AND OBTUSE MARGINAL (D-OM) BRANCHES, AND SVG BYPASS TO THE RCA. THREE MONTHS LATER, HE RETURNED WITH CHEST PAIN DURING CARDIAC REHABILITATION. HE WAS TREATED WITH 3 CYPHER SIROLIMUS-ELUTING STENTS, ONE OF WHICH WAS A 2.5X8 MM CYPHER SIROLIMUS ELUTING STENT TO THE OSTIUM OF THE SVG-D-OM BYPASS. IN (B)(6) 2007, HE RETURNED WITH UNSTABLE ANGINA THAT REQUIRED DEPLOYMENT OF A 2.5 X 18 MM CYPHER SIROLIMUS-ELUTING STENT TO TREAT THE OSTIUM OF THE SVG-D-OM BYPASS FOR THE FIRST EPISODE OF IN-STENT RESTENOSIS. IN (B)(6) 2008, THE PATIENT WAS READMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH THE SECOND EPISODE OF OSTIAL SVG-D-OM BYPASS GRAFT IN-STENT RESTENOSIS. FOR THIS EVENT, THE RESTENOSIS WAS TREATED WITH A 2.5 X 14 MM NON-CORDIS ZOTAROLIMUS-ELUTING STENT DEPLOYED AT 16 ATM FOR 25 SEC AND POSTDILATED AT 21 ATM FOR 30 SEC WITH 0% POSTPROCEDURE STENOSIS. IN LATE JUNE 2008, 85 DAYS AFTER THE APRIL 08 CORONARY INTERVENTION, THE PATIENT WAS READMITTED WITH RECURRENT CHEST PAIN AND A NON-ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION SHOWED PATENT LM AND CX STENTS AND TOTAL OCCLUSION OF THE OSTIUM OF THE SVG-D-OM BYPASS WITH EVIDENCE OF PROXIMAL STENT FRACTURE OF THE NON-CORDIS ZOTAROLIMUS-ELUTING STENT IN A HIGHLY DYNAMIC PORTION OF THE VESSEL. CORONARY ANGIOPLASTY WAS PERFORMED WITH A 1.5X 6 MM NON-CORDIS BALLOON, WHICH WAS INFLATED AT 12 ATM TO DILATE THE AREA OF IN-STENT RESTENOSIS DISTAL TO THE STENT FRACTURE. A 2.5 X 12 MM NON-CORDIS BALLOON WAS THEN INFLATED AT 10 ATM. THE PROXIMAL SEGMENT OF THE FRACTURED STENT REMAINED AROUND THE BALLOON CATHETER JUST PROXIMAL TO THE BALLOON. THE BALLOON WAS INFLATED AT LOW PRESSURE TO SECURE THE SMALL PROXIMAL SEGMENT OF THE NON-CORDIS FRACTURED STENT. THE GUIDEWIRE, BALLOON, AND GUIDING CATHETER WERE THEN PULLED OUT TOGETHER WITH RESTORATION OF THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 3 FLOW IN THE BYPASS GRAFT. THE PROXIMAL PORTION OF THE FRACTURED STENT, HOWEVER, DISLODGED AT THE FEMORAL ARTERY SHEATH LEVEL. VASCULAR SURGERY EVALUATION LOCATED THE SEPARATED NON-CORDIS STENT FRAGMENT IN A BRANCH OF THE RIGHT FEMORAL PROFUNDIS ARTERY. INTRAOPERATIVE ARTERIOGRAM SHOWED GOOD PERFUSION OF THE RIGHT SUPERFICIAL FEMORAL AND FEMORAL PROFUNDIS ARTERIES, THEREFORE, THE STENT FRAGMENT WAS LEFT IN THE FEMORAL PROFUNDIS BRANCH. THE PATIENT RECOVERED WITHOUT ANY UNTOWARD CARDIAC OR VASCULAR EVENTS AND WAS DISCHARGED 2 DAYS LATER. IT IS NOTEWORTHY THAT THE PATIENT HAD BEEN TREATED WITH AN APPROPRIATE MEDICAL REGIMEN FROM 2004 UNTIL THE (B)(6) 2008 ADMISSION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE IT IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) RECORD COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. CORONARY ARTERY RESTENOSIS IS USUALLY ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-CORONARY STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTION OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. UNSTABLE ANGINA OCCURS WHEN THE PATIENT FEELS CHEST PAIN THAT IS EXPERIENCED INCREASINGLY OFTEN AND/OR WITH LESS AND LESS EXERTION. THIS CONDITION REPRESENTS A SEVERITY OF CORONARY ARTERY DISEASE (CAD) BETWEEN STABLE ANGINA PECTORIS AND A MYOCARDIAL INFARCTION. UNSTABLE ANGINA IS USUALLY CAUSED BY BLOOD CLOTS OR ATHEROSCLEROTIC LESIONS THAT PARTIALLY OR TOTALLY BLOCK A CORONARY ARTERY, SUCH AS WITH THE CORONARY ARTERY RESTENOSIS REPORTED. A MYOCARDIAL INFARCTION (MI) RESULTS WHEN A CORONARY VESSEL BECOMES COMPLETELY OBSTRUCTED AND BLOCKS THE VESSEL FROM SUPPLYING BLOOD TO THE HEART MUSCLE, CAUSING THE HEART MUSCLE TO DIE. A NON-ST ELEVATION MI IS CHARACTERIZED BY LACK OF AN ST ELEVATION NOTED ON THE EKG. AN MI IS A KNOWN POTENTIAL ADVERSE EVENT RELATED TO HAVING A CORONARY STENT IMPLANTED. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY A SIDE BRANCH, CAUSING AN MI. BASED ON THE INFORMATION REPORTED, PATIENT FACTORS MOST LIKELY CONTRIBUTED TO THE EVENTS REPORTED. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES OF THE CORDIS STENTS THAT CONTRIBUTED TO THE REPORTED EVENTS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WERE TAKEN.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY VENERO ET AL A COMPLETELY FRACTURED ZOTAROLIMUS-ELUTING STENT IN AN AORTOCORONARY SAPHENOUS VEIN BYPASS GRAFT, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 81 (2013) 62-65; THE PATIENT WAS TREATED WITH 3 CYPHER SIROLIMUS-ELUTING STENTS, ONE OF WHICH WAS A 2.5 X 8 MM CYPHER SIROLIMUS-ELUTING STENT TO THE OSTIUM OF THE SVG-D-OM BYPASS. APPROXIMATELY 3 YEARS LATER, HE RETURNED WITH UNSTABLE ANGINA THAT REQUIRED DEPLOYMENT OF A 2.5 X18 MM CYPHER, SIROLIMUS-ELUTING STENT TO TREAT THE OSTIUM OF THE SVG-D-OM BYPASS FOR THE FIRST EPISODE OF IN-STENT RESTENOSIS. APPROXIMATELY ONE YEAR LATER, THE PATIENT WAS READMITTED WITH UNSTABLE ANGINA AND DIAGNOSED WITH THE SECOND EPISODE OF OSTIAL SVG-D-OM BYPASS GRAFT IN-STENT RESTENOSIS. FOR THIS EVENT, THE RESTENOSIS WAS TREATED WITH A 2.5 X 14 MM NON-CORDIS ZOTAROLIMUS-ELUTING STENT. 85 DAYS AFTER THE APRIL 08 CORONARY INTERVENTION, THE PATIENT WAS READMITTED WITH RECURRENT CHEST PAIN AND A NON-ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION SHOWED PATENT LM AND CX STENTS AND TOTAL OCCLUSION OF THE OSTIUM OF THE SVG-D-OM BYPASS WITH EVIDENCE OF PROXIMAL STENT FRACTURE OF THE NON-CORDIS ZOTAROLIMUS-ELUTING STENT. BETWEEN 2001 AND 2004, THE PATIENT HAD SEVERAL ADMISSIONS FOR UNSTABLE ANGINA FOR WHICH HE REQUIRED MULTIPLE PERCUTANEOUS CORONARY INTERVENTIONS (PCI) TO THE BYPASS GRAFTS. IN FEBRUARY 2004, THE PATIENT UNDERWENT RE-DO CABG WITH LEFT INTERNAL MAMMARY ARTERY BYPASS TO THE LAD, SEQUENTIAL SVG BYPASS TO THE DIAGONAL AND OBTUSE MARGINAL (D-OM) BRANCHES, AND SVG BYPASS TO THE RCA. THREE MONTHS LATER, HE RETURNED WITH CHEST PAIN DURING CARDIAC REHABILITATION. HE WAS TREATED WITH 3 CYPHER SIROLIMUS-ELUTING STENTS, ONE OF WHICH WAS A 2.5X8 MM CYPHER SIROLIMUS ELUTING STENT TO THE OSTIUM OF THE SVG-D-OM BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476381 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R