BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021293 · Received March 25, 2008

    Report

    Report Number
    3003742446-2008-00042
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 29, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS ADMITTED THIRTY-SEVEN MOS AFTER UNDERGOING DUAL CYPHER STENT IMPLANTATION OF THE LEFT ANTERIOR DESCENDING ARTERY WITH ACUTE MYOCARDIAL INFARCTION. THE OPERATIVE REPORT INDICATED THAT A 6 FRENCH SHEATH WAS INSERTED IN THE RIGHT FEMORAL ARTERY. A 6FRENCH JL4, JR4 AND A PIGTAIL WERE INSERTED FOR LEFT HEART CATHETERIZATION. THE PT WAS FOUND TO HAVE 100% OCCLUSION OF A MID LEFT ANTERIOR DESCENDING AND THE STENT WAS FRACTURED. A 6FRENCH FL4 RUNAWAY GUIDING CATHETER WAS INSERTED OVER A GUIDEWIRE. A BWM GUIDEWIRE WAS INSERTED TO CROSS THE LESION. THE GUIDEWIRE WAS UNDER THE STENT, RIGHT IN THE PROXIMAL PART OF THE STENT. A SINGLE VIEW ANGIOGRAM WAS PERFORMED. THE 950 OVER THE GUIDEWIRE BALLOON WAS PLACED IN THE PROXIMAL PART OF THE STENT AND THEN THE LESION WAS CROSS WITH THE GUIDEWIRE. THE BALLOON WAS REPLACED WITH A 2.5X15M QUANTUM MAVERICK RX, AND INFLATED TO 8-10 ATMOSPHERES. A 2.5X 20MM QUANTUM BALLOON WAS INFLATED TO 8 ATMOSPHERES IN THE DISTAL PART OF THE STENT AND THE 28MM CYPHER STENT. THE FRACTURED STENT WAS COVERED WITH 3X24MM LIBERTE BARE METAL STENT THAT WAS DEPLOYED AT 10 ATMOSPHERES. A SECOND 3X28 MM LIBERTE BARE METAL STENT WAS DEPLOYED AT 12 ATMOSPHERES. BOTH BARE METAL STENTS WERE POST-DILATED WITH A 3.5X20MM BALLOON AT 10 ATMOSPHERES AT THE DISTAL END AND THEN AT 14-16 ATMOSPHERES. AFTER THE STENT DEPLOYMENT, THERE WAS 0% RESIDUAL STENOSIS. TIMI FLOW WAS THREE. THE SHEATHS WOULD BE REMOVED THE LATER, SINCE THE PT RECEIVED K AND K. HEMODYNAMIC DATA INDICATED THAT THE (BP) BLOOD PRESSURE WAS 103/73. THE (LVEDP) LEFT VENTRICULAR ENDIASTOLIC PRESSURE WAS 14. THERE WAS NO GRADIENT ACROSS THE AORTIC VALVE. THE CORONARY ANGIOGRAM REVEALED A NORMAL LEFT MAIN, MID LAD WITH PREVIOUS FRACTURED STENT WITH 100% OCCLUSION OF THROMBUS, LEFT CIRCUMFLEX IS LARGE AND DOMINANT VESSEL WITH A 20% MID AREA STENOSIS, AND THE RIGHT CORONARY ARTERY IS SMALL AND NON-DOMINANT VESSEL WITH PROXIMAL STENT THAT WAS 40-50% RESTENOSIS. THE LEFT VENTRICULOGRAM SHOWS THAT THE APEX ANTERIOR WALL WAS HYPOKINETIC. THE (LV) LEFT VENTRICLE SYSTOLIC FUNCTION WAS MODERATELY DECREASED WITH AN EJECTION FRACTION OF 40%. THE CONCLUSION REVEALED TWO-VESSEL DISEASE. THE MID LAD 100% OCCLUSION WAS DUE TO THE FRACTURED STENTS. MODERATELY DECREASED LV SYSTOLIC FUNCTION, AND GOOD RESULTS OF THE STENTED LAD LESION. THE PROCEDURE PROTOCOL PROVIDED INDICATED THAT THE PT'S VITAL SIGNS WERE BP 109/67, WITH A HEART RATE OF 83 AND RESPIRATIONS RATE OF 18. THE ECG WAS NORMAL SINUS RHYTHM WITH ST ELEVATIONS. PRE PROCEDURE MEDICATIONS CONSISTED OF 0.9 NACL DRIP AT 50 ML/HR, NITROGLYCERIN DRIP AT 6ML/HR, ASPIRIN 162 MG AND PLAVIX 300 MG GIVEN ORALLY, MEDICATIONS GIVEN DURING THE PROCEDURE CONSISTED OF ATROPINE 0.5MG IV, TWO 81MG BABY ASPIRINS AND PLAVIX 300MG GIVEN ORALLY FENTANYL 25 AND 50MCG INTRAVENOUS (IV), VERSED 1 MG IV X2, LIDOCAINE 2% GIVEN AT THE ACCESS SITE, AND HEPARIN BOLUS OF 4200 UNITS. THE ACT PRIOR TO THE HEPARIN BOLUS WAS 167 SECONDS. THE DIAGNOSTIC PROCEDURE WAS STARTED WITH THE INSERTION OF 6 FRENCH SHEATH IN THE RIGHT FEMORAL ARTERY FOLLOWED BY A 6 FRENCH JL4, JR 4 AND A PIG TAIL DIAGNOSTIC CATHETERS. THE AORTIC PRESSURE WAS 97/69 AND THE LEFT VENTRICLE PRESSURE 99/9. A 50% STENOSIS WAS NOTED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 6FRENCH FL4 RUNAWAY GUIDING CATHETER WAS INSERTED OVER A GUIDEWIRE. A BWM GUIDEWIRE WAS INSERTED AND ACROSS THE LESION. A SINGLE VIEW ANGIOGRAM WAS PERFORMED. A 2.5X15MM QUANTUM MAVERICK RX WAS INSERTED. THIS BALLOON WAS REMOVED WITHOUT INFLATION. A SECOND BMW GUIDEWIRE WAS INSERTED. THE MAVERICK BALLOON WAS RE-INSERTED OVER THE SECOND GUIDEWIRE, BUT WAS REMOVED SEVERAL TIMES. THE SECOND BMW GUIDEWIRE WAS REMOVED AND A LUGE GUIDEWIRE WAS INSERTED. THE LUGE GUIDEWIRE WAS REMOVED. A MAVERICK 2X15MM (OTW) OVER THE WIRE WAS INSERTED VIA A 300CM BMW GUIDEWIRE. THE BALLOON WAS INFLATED AT 12 ATMOSPHERES FOR 20 SECONDS, 4 ATMOSPHERES FOR 17 SECS, AND 16 ATMOSPHERES FOR 23 SECS. THE PT WAS REMOVED FROM THE CATHETERIZATION ROOM AND TRANSFERRED TO RECOVERY WITH NO BLEEDING OR HEMATOMA OF THE ACCESS SITE. ADD'L INFO PROVIDED BY OUR SALES REP INDICATED THAT THE OPERATING PHYSICIAN INDICATED THAT THE STENTS MAY HAVE FRACTURE. FILMS AND FINAL PROCEDURE DICTATION WILL BE PROVIDED. FOR THE INDEX PROCEDURE, THIS 42 YR OLD WITH KNOWN PRIOR CARDIAC HISTORY CHEST PAIN AND ANTERIOR Q-WAVE MYOCARDIAL INFARCTION WITH POSITIVE TROPONIN WAS ADMITTED TO A FIRST FACILITY (HOSPITAL) AND THEN WAS TRANSFERRED TO (ANOTHER HOSPITAL) ANOTHER FACILITY FOR CARDIAC CATHETERIZATION AFTER BEING DIAGNOSED WITH ACUTE ANTERIOR MYOCARDIAL INFARCTION. THE PT INITIALLY PRESENTED WITH CHEST DISCOMFORT. THE PT WAS SENT HOME, AND CAME BACK TO THE EMERGENCY DEPT THREE OR FOUR DAYS LATER. THE PT HAD ELEVATED CARDIAC MARKERS WITH Q WAVE AND ST ELEVATION IN THE ANTERIOR LEADS. THE TROPONIN LEVEL WAS 4.42. CK TOTAL WAS 446 AND CK-MB WAS 33.8 SODIUM WAS 137, POTASSIUM 3.9, BUN 11, CREATININE 0.6, AND GLUCOSE 95. THE WHITE BLOOD COUNT WAS 10.4, HEMOGLOBIN WAS .7, AND PLATELET WAS 191. AT THE TIME OF ADMISSION OF THE PT'S VITALS WERE STABLE. PHYSICAL EXAMINATION WAS FAIRLY UNREMARKABLE. THE (EKG) ELECTROCARDIOGRAM SHOWED SINUS RHYTHM WITH ST SEGMENT ELEVATION IN THE ANTERIOR LEADS WITH Q WAVE. TROPONIN WAS 4.42 AND TOTAL CK WAS 446. THE PT UNDERWENT THE PROCEDURE AFTER OBTAINING ARTERIAL ACCESS THROUGH THE RIGHT FEMORAL ARTERY WITH 5FRENCH SHEATH. A JL4 CATHETER WAS ADVANCED OVER A GUIDEWIRE AND MULTIPLE ANGIOGRAMS WERE PERFORMED OF THE LEFT CORONARY ARTERY. THE JL4 CATHETER WAS REMOVED AND A JR4 CATHETER WAS INSERTED. MULTIPLE ANGIOGRAMS OF THE RIGHT CORONARY ARTERY WERE OBTAINED. A PIG TAIL CATHETER WAS PLACED AND AFTER REMOVAL OF THE JR4 CATHETER. A LEFT VENTRICULOGRAM WAS PERFORMED AND AFTER THE VENTRICULOGRAM, A PULLBACK WAS PERFORMED TO MEASURE AND RECORD PRESSURE ACROSS THE AORTIC VALVE. THE PIGTAIL WAS REMOVED, BUT THE SHEATH WAS LEFT IN PLACE. THE FEMORAL SHEATH WAS LEFT IN PLACE FOR INTERVENTION OF THE LEFT ANTERIOR DESCENDING ARTERY. THE HEMODYNAMIC AND ANGIOGRAPHIC DATA WAS THE FOLLOWING: AORTIC PRESSURE 100/64MMHG, (LV) LEFT VENTRICULAR PRESSURE WAS 100/1MMHG, (LVEDP) LEFT VENTRICULAR ENDIASTOLIC PRESSURE WAS 14-16MMHG. THE ESTIMATED EJECTION FRACTURE WAS 35% WITH SEVERE HYPOKINESIS OF THE ANTERIOR APICAL WALL. THE CORONARY ANGIOGRAM OF THE LEFT MAIN CORONARY ARTERY WAS NORMAL AND GIVES ORIGIN TO THE (LAD) LEFT ANTERIOR DESCENDING AND LEFT CIRCUMFLEX CORONARY ARTERIES. THE LAD ARTERY HAS A SUBTOTAL OCCLUSION IN THE MID-PORTION AFTER THE TAKEOFF OF THE DIAGONAL BRANCH. THERE IS TIMI 0-1 FLOW IN THE LAD. THE CIRCUMFLEX ARTERY IS VERY LARGE AND DOMINANT VESSEL AND GIVES ORIGIN TO LARGE OBTUSE MARGINAL BRANCHES. THERE ARE MINIMAL LUMINAL IRREGULARITIES IN THE CIRCUMFLEX ARTERY. THE RIGHT CORONARY ARTERY IS VERY SMALL AND NON-DOMINANT VESSEL AND HAS SEVERE DISEASE THROUGHOUT ITS COURSE. THE PT UNDERWENT THE PERCUTANEOUS INTERVENTIONAL PROCEDURE THE FOLLOWING DAY TO TREAT THE LAD. A 6FRENCH SHEATH WAS INSERTED TO REPLACE THE 5FRENCH FEMORAL SHEATH. A 6FRENCH XB LAD GUIDING CATHETER WAS USED TO ENGAGE THE LEFT MAIN CORONARY ARTERY. THE LAD APPEARED TO BE SUBTOTAL WITH 0 TIMI 1 FLOW. A BMW GUIDEWIRE (GW) WAS ADVANCED, BUT IT DID NOT CROSS THE TARGET SITE, THIS GUIDEWIRE REMOVED. A PILOT SHORT EXCHANGED GW WAS INSERTED AND PLACED IN THE DISTAL LAD. THEN, A VOYAGER 2.5X15MM BALLOON WAS INSERTED AND INFLATED MULTIPLE TIMES THROUGH THE MID SEGMENT OF THE MID LAD JUST DISTAL TO FIRST DIAGONAL BRANCH. THE INFLATIONS CONDUCTED WITH THE VOYAGER WERE 6 ATMOSPHERES FOR 30 SECONDS X2, 8 ATMOSPHERES FOR 30 SECONDS X2, 10 ATMOSPHERES FOR 45 SECONDS, AND 12 ATMOSPHERES FOR 50 SECONDS. THERE WAS STILL SIGNIFICANT RESIDUAL STENOSIS ESPECIALLY IN THE PROXIMAL SEGMENT. A CYPHER STENTS (2.5X28MM) WAS DEPLOYED AT 11 ATMOSPHERES FOR SECONDS. THE STENT BALLOON WAS THEN REMOVED AND A 2.5 X 13MM CYPHER STENT WAS DEPLOYED AT 14 ATMOSPHERES FOR 35 SECONDS WITH APPROX 1 1-2MM OVERLAP. THE STENT BALLOON WAS PASSED INTO THE JUNCTION AND INFLATED 16 ATMOSPHERES FOR 30 SECONDS. THERE STILL APPEARED TO BE APPROX 30% RESIDUAL STENOSIS IN THE MID SEGMENT OF THE DISTAL STENT AND ALSO THE MID TO DISTAL SEGMENT OF THE PROXIMAL STENT. MULTIPLE INFLATIONS WITH A 3X15MM QUANTUM MAVERICK BALLOON WAS PERFORMED TO 12 ATMOSPHERES FOR 30 SECONDS, 18 ATMOSPHERES FOR 30 SECONDS AND 18 ATMOSPHERES FOR 45 SECONDS. MULTIPLE VIEWS WERE THEN OBTAINED AFTER INTRACORONARY NITROGLYCERIN WAS ADMINISTERED. THERE WAS LESS THAN 10% RESIDUAL STENOSIS. THERE WAS NO EVIDENCE OF DISSECTION. THE TIMI FLOW WAS THREE. THE PT WAS HEMODYNAMICALLY STABLE AND HAVING CHEST PAIN 1 OF 10-CHEST DISCOMFORT. THE PT STATED, "IT WAS LESS SEVERE THAN PRIOR TO THE PROCEDURE HAS STARTED". THE PT WILL BE ON REOPRO FOR 12 HRS, AND WAS GIVEN 600MG PLAVIX IN THE CATHERIZATION LAB. THE PT RECEIVED HEPARIN AND THE LAST ACT WAS 196 SECONDS. THEREFORE, THE HEPARIN WAS DISCONTINUED. POST PROCEDURE, THE PT REMAINED STABLE. NO ELEVATION IN THE CARDIAC MARKERS. HEMOGLOBIN WAS STABLE. THE PT HAD SLIGHT TENDERNESS IN THE GROIN (ACCESS SIGHT) BUT HAD GOOD DISTAL PULSES AND GOOD FEMORAL PULSE AND WAS AMBULATING WITHOUT ANY DIFFICULTIES. THE HEMOGLOBIN WAS STABLE. THE PT DISCHARGED HOME IN STABLE CONDITION. DISCHARGED MEDICATION CONSISTED OF ASPIRIN 325MG EVERY DAY, PLAVIX 75MG TWO TIMES A DAY, METOPROLOL 25MG TWICE A DAY, LIPITOR 40MG ONCE A DAY, AND LISIPINOPRIL 5MG ONCE A DAY. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS THE SECOND OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PT, WHICH IS ASSOCIATED WITH MFG REPORT #3003742446-2008-00041.

    Description of Event or Problem · 1

    THREE YRS AFTER UNDER DUAL CYPHER STENT IMPLANTATION OF THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD), THE PT UNDERWENT A DIAGNOSTIC CARDIOVASCULAR PROCEDURE THAT REVEALED A >100% OCCLUSION OF THE MID LAD WITHIN THE TWO CYPHER STENTS. THE PHYSICIAN COMMENTED THAT THE CYPHER STENTS MIGHT HAVE FRACTURED. PROCEDURE FILMS WILL BE PROVIDED. A 6FRENCH JL4 RUNAWAY WAS INSERTED. A BMW GUIDEWIRE WAS ADVANCED ACROSS THE LESION FOLLOWED BY A 2.5X15MM MAVERICK BALLOON, BUT BOTH UNITS WERE INSERTED AND REMOVED MULTIPLE TIMES WITHOUT INFLATIONS. THE 2.5MM BALLOON WAS REMOVED ALONG WITH THE GUIDEWIRE AND A LUGE GUIDEWIRE AND 2.0X15 MAVERICK BALLOON WAS INSERTED. THIS BALLOON WAS INFLATED TO 12 ATMS FOR 20 SECONDS, 4 ATMOSPHERES FOR 17 SECONDS, AND 16 ATMOSPHERES FOR 23 SECONDS. THE GUIDEWIRE AND BALLOON WERE REMOVED. THE PT WAS REMOVED FROM THE LAB AND SEND TO RECOVERY. ADDENDUM: THE OPERATING REPORT INDICATED THAT THE PT WAS ADMITTED WITH AN ACUTE MYOCARDIAL INFARCTION AND THE ANGIOGRAM SHOWED CORONARY STENT THROMBOSIS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R 6FRENCH JL4| QUANTUM MAVERICK BALLOON| LIBETER STENTS