CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 9616099-2012-00661
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- January 1, 2006
- Report Date
- October 30, 2012
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
THE PATIENT WAS PREPARED AND DRAPED IN STANDARD STERILE FASHION AND THE RIGHT AND LEFT NATIVE CORONARY ARTERIES AND MAMMARY GRAFT WERE IMAGED VIA A RIGHT FEMORAL APPROACH USING A 6FR SYSTEM, JUDKINS 4 LEFT AND RIGHT AS WELL AS INTERNAL MAMMARY DIAGNOSTIC CATHETERS. THE RIGHT CORONARY ARTERY WAS OCCLUDED PROXIMALLY AND COLLATERALIZED FROM THE LEFT. THE PROXIMAL LEFT MAIN ARTERY WAS SEVERELY STENOSED (70% DIAMETER STENOSIS BY QCA, INCREASED FROM EARLIER REPORTS), WHILE THE MAMMARY GRAFT WAS A SMALL VESSEL BECOMING DIFFUSELY STENOTIC AT ITS DISTAL THIRD LEADING INTO THE 1ST DIAGONAL. CONSIDERING THE PRESENCE OF PROLONGED REST PAIN AND ABSENCE OF IMPROVEMENT WITH CONSERVATIVE THERAPY, THE DECISION WAS MADE TO PROCEED WITH REVASCULARIZATION. THE PROHIBITIVE RISK ASSOCIATED WITH A SECOND BYPASS IN AN (B)(6) PATIENT, AND THE CLINICAL CONTEXT OF AN ONGOING ACUTE CORONARY SYNDROME, FAVORED IMMEDIATE PERCUTANEOUS INTERVENTION OVER REPEAT SURGICAL REVASCULARIZATION. AFTER CONSIDERATION OF THE VARIOUS ALTERNATIVES, WE DECIDED TO TREAT THE NATIVE LEFT MAIN STENOSIS, WHILE PARTIALLY PROTECTING THE LEFT SYSTEM BY PRECEDING LEFT MAIN INTERVENTION BY SIMPLE BALLOON ANGIOPLASTY OF THE MAMMARY GRAFT. AN ACTIVATED CLOTTING TIME OF 250 SECONDS WAS ACHIEVED WITH ADDITIONAL HEPARIN BOLUS IV, AND THE MAMMARY GRAFT WAS SUCCESSFULLY DILATED TO 2.0 MM. IN ORDER TO APPROACH THE PROXIMAL LEFT MAIN, A 6FR CORDIS JL4 GUIDE PROVIDED THE BEST ALIGNMENT AND SUPPORT WITHOUT EXCESSIVELY ENGAGING THE OSTIUM. OVER AN ACS HI-TORQUE FLOPPY GUIDEWIRE, A 3.5 X 12 MM SPRINTER BALLOON WAS INFLATED TO 12 ATM TO PREDILATE THE LESION. THE REFERENCE DIAMETER OF THE LEFT MAIN WAS ESTIMATED TO BE 4.75 MM, AND A 3.5 X 13 MM CYPHER DRUG-ELUTING STENT WAS ADVANCED TO THE PROXIMAL VESSEL AND INFLATED TO 16 ATM FOR 4 SECONDS. EVEN AS WE ADVANCED A 4.5 X 11 MM NONCOMPLIANT POSTDILATION BALLOON IN THE GUIDE WITH THE AIM OF INCREASING THE DIAMETER OF THE CYPHER STENT TO 4.75 MM, IT BECAME APPARENT THAT THE STENT WAS NO LONGER IN THE PROXIMAL LEFT MAIN ARTERY, BUT HAD SLID BACK OVER THE GUIDE CATHETER AND WAS NOW RESTING AT THE PRIMARY CURVE OF THE JL4, NOT UNLIKE A RING OVER A FINGER. WHILE THE MIGRATED STENT WAS SAFELY RETAINED OVER THE GUIDE, AN ULTRA 5.0 X 13 MM BARE METAL STENT WAS ADVANCED AND INFLATED AT 14 ATM TO SECURE THE PROXIMAL LEFT MAIN AT THE INITIAL ANGIOPLASTY SITE AND OPTIMAL STENT RESULT WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND. PLEASE NOTE THAT THE EXACT EVENT DATE IS UNKNOWN; HOWEVER, THE LITERATURE REVIEW WAS PUBLISHED IN 2006. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE REVIEW, LAROSE ET AL, WHEN SIZE MATTERS: LESIONS LEARNED FROM LEFT MAIN STENT EMBOLIZATION AND RETRIEVAL; JOURNAL OF INTERVENTIONAL CARDIOLOGY; 19(4):350-5, 2006 AUG., THE USE OF A DES OUTSIDE THE APPROVED VESSEL DIAMETER TO TREAT LEFT MAIN CORONARY ARTERY DISEASE LED TO RETROGRADE MIGRATION OF THE STENT OVER THE GUIDING CATHETER. AN (B)(6) GENTLEMAN WAS URGENTLY TRANSFERRED TO THE HOSPITAL FOR HIGH RISK ACUTE CORONARY SYNDROME. THE PATIENT PRESENTED TO THE ED WITH CRUSHING SUBSTERNAL CHEST DISCOMFORT. UPON ARRIVAL, CHEST PAIN PERSISTED AND COULD NOT BE RELIEVED, PHYSICAL EXAMINATION WAS UNREMARKABLE (HEART RATE 72/MIN, BLOOD PRESSURE 140/90 MMHG, RESPIRATORY RATE 26/MIN, SATURATION 92% ON ROOM AIR), AND ELECTROCARDIOGRAM WAS NOTABLE FOR NEW DIFFUSE 1.5 MM ST SEGMENT DEPRESSION. HISTORY INCLUDED CORONARY BYPASS 4 YEARS PRIOR FOR SIGNIFICANT LEFT MAIN STENOSIS, PERMANENT PACEMAKER IMPLANTATION 2 YEARS PRIOR FOR SYMPTOMATIC BRADYCARDIA, AS WELL AS HYPERTENSION AND HYPERLIPIDEMIA, WHICH WERE BOTH CONTROLLED WITH MEDICATIONS. A CORONARY ANGIOGRAM 2 YEARS EARLIER HAD SHOWN OCCLUSION OF ALL VENOUS GRAFTS WHILE THE LEFT INTERNAL MAMMARY GRAFT TO 1ST DIAGONAL BRANCH WAS WIDELY PATENT. A RECENT PHARMACOLOGICAL NUCLEAR MEDICINE STUDY PERFORMED FOR CRESCENDO ANGINA DEMONSTRATED REVERSIBLE ANTERIOR ISCHEMIA, LEADING TO MODIFICATION OF HIS PHARMACOLOGICAL THERAPY. A CONCOMITANT RADIONUCLIDE VENTRICULOGRAPHY INDICATED PRESERVED LEFT VENTRICULAR FUNCTION (EJECTION FRACTION 56%). MEDICATIONS INCLUDED ASA 81 MG DAILY, CLOPIDOGREL 75 MG DAILY, ATORVASTATIN 40 MG DAILY, METOPROLOL XL 100 DAILY, AND RAMIPRIL 5 MG TWICE DAILY. UPON ARRIVAL TO THE EMERGENCY DEPARTMENT, ASA WAS COMPLETED TO 325 MG, HEPARIN WAS BOLUSED 50 U/KG IV FOLLOWED BY INFUSION AT 18 U/KG PER HOUR, AND EPTIFIBATIDE WAS BOLUSED TWICE AT 180 G/KG IV FOLLOWED BY 2 G/KG PER MINUTE INFUSION. THE PATIENT WAS PREPARED AND DRAPED IN STANDARD STERILE FASHION AND THE RIGHT AND LEFT NATIVE CORONARY ARTERIES AND MAMMARY GRAFT WERE IMAGED VIA A RIGHT FEMORAL APPROACH USING A 6FR SYSTEM, JUDKINS 4 LEFT AND RIGHT AS WELL AS INTERNAL MAMMARY DIAGNOSTIC CATHETERS. THE RIGHT CORONARY ARTERY WAS OCCLUDED PROXIMALLY AND COLLATERALIZED FROM THE LEFT. THE PROXIMAL LEFT MAIN ARTERY WAS SEVERELY STENOSED (70% DIAMETER STENOSIS BY QCA, INCREASED FROM EARLIER REPORTS), WHILE THE MAMMARY GRAFT WAS A SMALL VESSEL BECOMING DIFFUSELY STENOTIC AT ITS DISTAL THIRD LEADING INTO THE 1ST DIAGONAL. CONSIDERING THE PRESENCE OF PROLONGED REST PAIN AND ABSENCE OF IMPROVEMENT WITH CONSERVATIVE THERAPY, THE DECISION WAS MADE TO PROCEED WITH REVASCULARIZATION. THE PROHIBITIVE RISK ASSOCIATED WITH A SECOND BYPASS IN AN (B)(6) PATIENT, AND THE CLINICAL CONTEXT OF AN ONGOING ACUTE CORONARY SYNDROME, FAVORED IMMEDIATE PERCUTANEOUS INTERVENTION OVER REPEAT SURGICAL REVASCULARIZATION. AFTER CONSIDERATION OF THE VARIOUS ALTERNATIVES, WE DECIDED TO TREAT THE NATIVE LEFT MAIN STENOSIS, WHILE PARTIALLY PROTECTING THE LEFT SYSTEM BY PRECEDING LEFT MAIN INTERVENTION BY SIMPLE BALLOON ANGIOPLASTY OF THE MAMMARY GRAFT. AN ACTIVATED CLOTTING TIME OF 250 SECONDS WAS ACHIEVED WITH ADDITIONAL HEPARIN BOLUS IV, AND THE MAMMARY GRAFT WAS SUCCESSFULLY DILATED TO 2.0 MM. IN ORDER TO APPROACH THE PROXIMAL LEFT MAIN, A 6FR CORDIS JL4 GUIDE PROVIDED THE BEST ALIGNMENT AND SUPPORT WITHOUT EXCESSIVELY ENGAGING THE OSTIUM. OVER AN ACS HI-TORQUE FLOPPY GUIDEWIRE, A 3.5 X 12 MM SPRINTER BALLOON WAS INFLATED TO 12 ATM TO PREDILATE THE LESION. THE REFERENCE DIAMETER OF THE LEFT MAIN WAS ESTIMATED TO BE 4.75 MM, AND A 3.5 X 13 MM CYPHER DRUG-ELUTING STENT WAS ADVANCED TO THE PROXIMAL VESSEL AND INFLATED TO 16 ATM FOR 4 SECONDS. EVEN AS WE ADVANCED A 4.5 X 11 MM NONCOMPLIANT POSTDILATION BALLOON IN THE GUIDE WITH THE AIM OF INCREASING THE DIAMETER OF THE CYPHER STENT TO 4.75 MM, IT BECAME APPARENT THAT THE STENT WAS NO LONGER IN THE PROXIMAL LEFT MAIN ARTERY, BUT HAD SLID BACK OVER THE GUIDE CATHETER AND WAS NOW RESTING AT THE PRIMARY CURVE OF THE JL4, NOT UNLIKE A RING OVER A FINGER. WHILE THE MIGRATED STENT WAS SAFELY RETAINED OVER THE GUIDE, AN ULTRA 5.0 X 13 MM BARE METAL STENT WAS ADVANCED AND INFLATED AT 14 ATM TO SECURE THE PROXIMAL LEFT MAIN AT THE INITIAL ANGIOPLASTY SITE AND OPTIMAL STENT RESULT WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND. THE CYPHER STENT HAS BEEN UNAVAILABLE FOR ANALYSIS. THERE HAS BEEN NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. INACCURATE PLACEMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL STENTING PROCEDURES. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS PRODUCT WAS USED OUTSIDE OF THE IFU GUIDELINES IN TERMS OF APPROPRIATE SIZING. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED DIFFICULTY.
AS REPORTED IN THE LITERATURE REVIEW, LAROSE ET AL, WHEN SIZE MATTERS: LESIONS LEARNED FROM LEFT MAIN STENT EMBOLIZATION AND RETRIEVAL; JOURNAL OF INTERVENTIONAL CARDIOLOGY; 19(4):350-5, 2006 AUG., THE USE OF A DES OUTSIDE THE APPROVED VESSEL DIAMETER TO TREAT LEFT MAIN CORONARY ARTERY DISEASE LED TO RETROGRADE MIGRATION OF THE STENT OVER THE GUIDING CATHETER. AN (B)(6) GENTLEMAN WAS URGENTLY TRANSFERRED TO THE HOSPITAL FOR HIGH RISK ACUTE CORONARY SYNDROME. THE PATIENT PRESENTED TO THE ED FOR CRUSHING SUBSTERNAL CHEST DISCOMFORT. UPON ARRIVAL, CHEST PAIN PERSISTED AND COULD NOT BE RELIEVED, PHYSICAL EXAMINATION WAS UNREMARKABLE (HEART RATE 72/MIN, BLOOD PRESSURE 140/90 MMHG, RESPIRATORY RATE 26/MIN, SATURATION 92% ON ROOM AIR), AND ELECTROCARDIOGRAM WAS NOTABLE FOR NEW DIFFUSE 1.5 MM ST SEGMENT DEPRESSION. HISTORY INCLUDED CORONARY BYPASS 4 YEARS PRIOR FOR SIGNIFICANT LEFT MAIN STENOSIS, PERMANENT PACEMAKER IMPLANTATION 2 YEARS PRIOR FOR SYMPTOMATIC BRADYCARDIA, AS WELL AS HYPERTENSION AND HYPERLIPIDEMIA, WHICH WERE BOTH CONTROLLED WITH MEDICATIONS. A CORONARY ANGIOGRAM 2 YEARS EARLIER HAD SHOWN OCCLUSION OF ALL VENOUS GRAFTS WHILE THE LEFT INTERNAL MAMMARY GRAFT TO 1ST DIAGONAL BRANCH WAS WIDELY PATENT. A RECENT PHARMACOLOGICAL NUCLEAR MEDICINE STUDY PERFORMED FOR CRESCENDO ANGINA DEMONSTRATED REVERSIBLE ANTERIOR ISCHEMIA, LEADING TO MODIFICATION OF HIS PHARMACOLOGICAL THERAPY. A CONCOMITANT RADIONUCLIDE VENTRICULOGRAPHY INDICATED PRESERVED LEFT VENTRICULAR FUNCTION (EJECTION FRACTION 56%). MEDICATIONS INCLUDED ASA 81 MG DAILY, CLOPIDOGREL 75 MG DAILY, ATORVASTATIN 40 MG DAILY, METOPROLOL XL 100 DAILY, AND RAMIPRIL 5 MG TWICE DAILY. UPON ARRIVAL TO THE EMERGENCY DEPARTMENT, ASA WAS COMPLETED TO 325 MG, HEPARIN WAS BOLUSED 50 U/KG IV FOLLOWED BY INFUSION AT 18 U/KG PER HOUR, AND EPTIFIBATIDE WAS BOLUSED TWICE AT 180 G/KG IV FOLLOWED BY 2 G/KG PER MINUTE INFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |