BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083546 · Received July 28, 2008

    Report

    Report Number
    9616099-2008-01866
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    September 18, 2007
    Report Date
    July 1, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MFR REPORT NUMBERS ARE 9616099-2008-01866 AND 9616099-2008-01867. AN EVENT FROM A LITERATURE REVIEW INDICATED THAT A PT EXPERIENCED A "LATE GIANT CORONARY ANEURYSM" AFTER HAVING A STENT IMPLANTED THAT THEN FRACTURED. THE PT'S HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, PERMANENT PACEMAKER, DIABETES AND OBESITY. THE PT'S HISTORY PUTS THEM AT INCREASED RISK FOR A MACE. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESIONS WERE THE MID TO PROXIMAL RIGHT CORONARY ARTERY (RCA) AND THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE RCA WAS TOTALLY OCCLUDED WITH COLLATERALS COMING FROM THE LEFT CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED AND THEN A DISSECTION WAS VISUALIZED AT THE PROXIMAL RCA. THREE CYPHER STENTS (2.5/28MM, 2.5/18MM AND 3.0/18MM) WERE THE IMPLANTED FROM THE DISTAL RCA TO THE OSTIUM IN AN OVERLAPPING FASHION. THE STENTS WERE POST DILATED WITH SATISFACTORY RESULTS. THREE WEEKS LATER THE PT RETURNED FOR TREATMENT TO THE LAD, WHICH HAD A SEVERE STENOSIS IN THE MID SECTION. TWO CYPHER STENT WERE IMPLANTED FOLLOWED BY A BARE METAL STENT TO TREAT A DISTAL EDGE DISSECTION THAT HAD OCCURRED. FINAL ANGIOGRAPHY SHOWED GOOD RESULTS. CAG OF THE RCA AT THE TIME REVEALED NO IN-STENT RESTENOSIS BUT A PULSATILE DEFORMATION IN THE GEOMETRY OF ONE OF THE STENTS, THE 3.0MM X 18MM CYPHER. THE PT DID NOT HAVE ANGINA AFTER THE PROCEDURE AND WAS DISCHARGED ON ASPIRIN AND TICLID. EIGHT MONTHS LATER, THE PT PRESENTED WITH ANGINA. ANGIOGRAPHY REVEALED FOCAL IN-STENT RESTENOSIS IN THE PREVIOUSLY IMPLANTED BARE METAL STENT AND A LARGE SACCULAR CORONARY ANEURYSM IN THE PROXIMAL RCA. THE MID LAD WITH THE BMS WAS TREATED WITH POBA. IVUS WAS PERFORMED ON THE RCA AND REVEALED AN ABSENCE OF STENT STRUTS. "IT WAS SUGGESTED THAT THE ANEURYSM MIGHT BE A PSEUDO ANEURYSM WITHOUT ANY THROMBUS FORMATION, BECAUSE IVUS DID NOT SHOW A THREE-LAYER APPEARANCE OF ARTERIAL WALL. CONSIDERING THE POTENTIAL RISK OF CORONARY RUPTURE, THE ENTRY OF CORONARY ANEURYSM WAS FINALLY SEALED WITH A POLYTETRAFLUOROETHYLENE (PTFE)-COVERED STENT." THE STERILE LOT NUMBERS FOR THE STENTS IS UNK THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. CORONARY ARTERY ANEURYSMS ARE STATED IN THE IFU AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. CORONARY ARTERY ANEURYSMS MAY ALSO OCCUR FROM TRAUMA, BLUNT OR IATROGENIC THAT OCCURS IN THE CATHETERIZATION LAB DURING AN INTERVENTIONAL PROCEDURE. THE ARTICLE DID INDICATE THAT THERE WAS DIFFICULTY IN GETTING A WIRE TO CROSS THE LESION. THAT, IN ADDITION TO TIP OF THE GUIDING CATHETER PUSHING AGAINST THE INTIMA OF THE VESSEL WALL WHILE TRYING TO CROSS THE OCCLUSION MAY HAVE CAUSED INTIMAL TRAUMA TO THE VESSEL WALL. ALTHOUGH INFLATION PRESSURES ARE UNK CHRONIC TOTAL OCCLUSION USUALLY REQUIRE HIGHER INFLATION PRESSURES TO OBTAIN A PATENT LUMAN. EXCESSIVE DILATATION MAY CAUSE DEEP WALL INJURY OF THE VESSEL THAT MAY LEAD TO ANEURYSM FINDINGS. THE IFU ALSO INDICATES THAT THE SAFETY AND EFFECTIVENESS OF THE CYPHER STENT HAS NOT YET BEEN ESTABLISHED IN PTS WITH CHRONIC TOTAL OCCLUSIONS. BASED ON THE LIMITED INFO PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE DUE TO STABLE ANGINA. CORONARY ANGIOGRAPHY (CAG) REVEALED A CHRONIC TOTAL OCCLUSION AT THE MIDDLE PORTION OF THE RIGHT CORONARY ARTERY, (RCA) WITH A DIFFUSE LESION PROXIMAL TO THE OCCLUDED SEGMENT. A SEVERE STENOSIS AT THE MIDDLE PORTION OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS ALSO REVEALED. THERE WERE GRADE 3 COLLATERALS FROM THE LEFT CIRCUMFLEX ARTERY (LCX) TO RCA. THE LESION WAS PRE-DILATED. AFTER PRE-DILATION, CAG REVEALED A DISSECTION AT THE PROXIMAL RCA. THREE CYPHER STENTS WERE THEN DEPLOYED FROM THE DISTAL RCA TO THE RCA OSTIUM WITH AN OVERLAP BETWEEN EACH STENT. POST-DILATATION WAS CONDUCTED WITH GOOD ANGIOGRAPHIC RESULTS. THREE WEEKS LATER, INTERVENTION WAS PROVIDED IN THE LAD LESION. TWO CYPHER STENTS WERE DEPLOYED IN LAD AND ONE ZETA TM BARE-METAL STENT WAS USED FOR A BAILOUT SITUATION TO TREAT A DISTAL EDGE DISSECTION. FINAL ANGIOGRAPHY SHOWED GOOD ANGIOGRAPHIC RESULTS. CAG OF THE RCA AT THE TIME REVEALED NO IN-STENT RESTENOSIS, BUT A PULSATILE DEFORMATION IN GEOMETRY OF ONE OF THE STENTS (3.0X18MM CYPHER). THE PT WAS DISCHARGED ON ASPIRIN AND TICLOPIDINE. EIGHT MONTHS LATER, AFTER THE TWO INTERVENTIONS, THE PT WAS ADMITTED WITH ANGINA. CAG REVEALED A FOCAL AND TIGHT IN-STENT RESTENOSIS (90%) AT THE SITE OF BARE-METAL STENT IN THE MIDDLE PORTION OF THE LAD. CAG ALSO REVEALED A LARGE ECCENTRIC SACCULAR CORONARY ANEURYSM (17MM X 9MM) AT THE PROXIMAL RCA. THE MIDDLE PORTION OF LAD WAS RETREATED WITH A BALLOON DILATATION, WHICH LED TO A GOOD ANGIOGRAPHIC RESULT. IVUS THEN SHOWED ABSENCE OF STENT STRUTS AROUND THE ORIFICE OF ANEURYSM OF RCA, WHICH SUGGESTED A FRACTURE OF CYPHER. THIS IS THE SEGMENT THAT CORRESPONDED TO THE PORTION THAT SHOWED A MARKED PULSATILE DEFORMATION AT THE TIME THE LAD WAS TREATED. IT WAS SUGGESTED THAT THE ANEURYSM MIGHT BE PSEUDOANEURYSM WITHOUT ANY THROMBUS FORMATION, BECAUSE IVUS DID NOT SHOW A THREE-LAYER APPEARANCE OF ARTERIAL WALL. CONSIDERING THE POTENTIAL RISK OF CORONARY RUPTURE, THE ENTRY OF CORONARY ANEURYSM WAS FINALLY SEALED WITH A POLYTETRAFLUOROETHYLENE (PTFE)- COVERED STENT.

    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 73 YR Hospitalization| L| R A 3.0MM NON-COMPLIANT BALLOON| A MIRACLE GUIDEWIRE| AND A 2.0MM BALLOON CATHETER| A .014- IN FLOPPY GUIDEWIRE