BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 731839 · Received June 29, 2006

    Report

    Report Number
    9616099-2006-00735
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    May 29, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TARGET LESION WERE THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND THE FIRST (1ST) DIAGONAL. THE LESIONS WERE REPORTED TO BE: DE NOVO, ECCENTRIC, A BIFURCATED LESION, HEAVILY FLEXION, TORTUOUS, HEAVILY CALCIFIED, 40 MM IN LENGTH, 2.5 MM VESSEL DIAMETER, AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.0/30 MM BALLOON AT 10 ATM FOR 30 SEC. A CYPHER 2.5/28 MM STENT WAS IMPLANTED AT 16 ATM FOR 20 SEC. A SECOND CYPHER 2.5/18 MM STENT WAS IMPLANTED AT 20 ATMS FOR 15 SEC PROXIMAL TO THE FIRST STENT IN OVERLAPPING FASHION. THE DISTAL 2.5/28 MM STENT WERE POST-DILATED. THERE WAS A REPORTED 75% LESION DISTAL TO THE 2.5/28 MM STENT IN THE 1ST DIAGONAL THAT WAS NOT TREATED DUE TO HEAVY CALCIFICATION, FLEXION AND DIFFICULTY ACCESSING THE LESION. AFTER THE INTERVENTION THE PERIPHERAL FLOW TO THE DISTAL LAD WAS STOPPED (TIMI FLOW 0). NO INTERVENTION WAS DONE DUE TO THE VESSEL DIAMETER BEING NARROW ORIGINALLY. THERE WAS NO REPORTED POST-PROCEDURAL MI. IVUS WAS NOT DONE. THE RESIDUAL STENOSIS WAS REPORTED TO BE 25%. AN ACT OF 339 WAS REPORTED. PLEASE NOTE THAT DEVICE (LOT # I0106070) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2006-00734 AND # 9616099-2006-00735. A MALE WITH A HISTORY OF PREVIOUS MI, PREVIOUS PCI AND FIBROID LUNG EXPERIENCED A THROMBOTIC EVENT THREE MONTHS POST CYPHER STENT IMPLANTATIONS. THE REASON FOR THE PT'S INITIAL ADMISSION WAS NOT REPORTED; BUT AN ELECTIVE ANGIOGRAM REVEALED A LESION IN HIS PROXIMAL LAD/FIRST DIAGONAL. THIS PT'S ADVANCED AGE AND HISTORY PUT HIM AT INCREASED RISK FOR MACE. PRE PROCEDURAL MEDICATIONS INCLUDED ASA AND TICLID; WHILE INTRA PROCEDURAL MEDICATIONS INCLUDED HEPARIN. THE HIGHEST RECORDED RECORD WAS 339 SECONDS. THE LESION WAS DESCRIBED AS DE NOVO, TYPE C, 75% OCCLUDED, 2.5MM IN DIAMETER, 40MM IN LENGTH, ECCENTRIC, BIFURCATING, HEAVILY CALCIFIED, TORTUOUS AND LOCATED IN AN AREA OF FLEXION. THE SAFETY AND EFFECTIVENESS OF THE CYPHER STENT HAS NOT BEEN ESTABLISHED IN THESE TYPE OF VESSELS AND /OR LESIONS. THE LESION WAS PRE-DILATED PRIOR TO THE PLACEMENT OF A 2.50 X 28MM CYPHER STENT AT A MAXIMUM INFLATION PRESSURE OF 20ATM. ACCORDING TO THE IFU, THE RATED BURST PRESSURE OF THE CYPHER STENT SHOULD NOT BE EXCEEDED IN ORDER TO PREVENT INTIMAL DAMAGE OR VESSEL DISSECTION. A RESIDUAL STENOSIS OF 25% WAS REPORTED DESPITE POST DILATION. ACCORDING TO THE IFU, THE USE OF THE CYPHER STENT IS CONTRAINDICATED IN PTS JUDGED TO HAVE LESIONS THAT PREVENT THE COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. AFTER IMPLANTATION OF THE CYPHER STENT, FLOW TO THE REST OF THE LAD STOPPED. THIS WAS LEFT UNTREATED SINCE THE VESSEL DIAMETER OF THE REMAINING LAD WAS NARROW. OF NOTE, DISTAL DISEASE IN THE FIRST DIAGONAL WAS LEFT UNTREATED SINCE THE VESSEL WAS TOO CALCIFIED AND FLEXED AT THIS POINT. THE PT WAS DISCHARGED ON MEDICATIONS THAT INCLUDED ASA AND TICLID. ONE AND A HALF MONTHS AFTER THE INDEX PROCEDURE, THE PT DEVELOPED A RASH AND DISCONTINUED. THE PT WAS STARTED ON SARPOGRELATE AT THIS POINT. THREE MONTHS AFTER THE INDEX PROCEDURE, THE PT EXPERIENCED CHEST PAIN AND DIFFICULTY BREATHING. HE RULED IN FOR AN AMI AND SUBSEQUENTLY DEVELOPED ACUTE HEART FAILURE WITH AN LVEF OF 20%. A REPEAT ANGIOGRAM REVEALED THROMBUS INSIDE THE IMPLANTED CYPHER STENTS. THE PT WAS TREATED WITH THE INSERTION OF AN IABP AND PTCA. DURING THE PTA, A VESSEL PERFORATION OCCURRED INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENT. THIS WAS THEN TREATED WITH FURTHER PTCA. ACCORDING TO THE PROCEDURAL PHYSICIAN, THE PROBABLE CAUSED OF THE THROMBOTIC EVENT INCLUDED THE UNDER-DIALATION OF THE STENT, THE UNTREATED DISTAL DISEASE AND THE DISCONTINUATION OF THE PT'S TICLID. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THERE ARE PT, VESSEL PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT. THE DEVICE HISTORY RECORD FOR THE OTHER PRODUCT INVOLVED IN THIS COMPLAINT IS NOT YET AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE REPORT FROM THE AFFILIATE INDICATED THAT APPROX THREE AND ONE-HALF (3 1/2) MONTHS AFTER THE INDEX PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND BREATHING DIFFICULTY. THE PT WAS DIAGNOSED WITH AN ACUTE MYOCARDIAL INFARCTION (AMI) WHICH LED TO ACUTE HEART FAILURE (AHF). THE PT'S EJECTION FRACTION (EF) WAS REPORTED TO BE APPROX 20% . CORONARY ANGIOGRAPHY WAS DONE AND DEMONSTRATED THROMBUS INSIDE THE PREVIOUSLY IMPLANTED CYPHER STENTS. AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED AND PTCA WAS DONE USING A 2.5/15 MM BALLOON AT 14 ATM SEVERAL TIMES FOR 60 SEC TOTAL. DURING THE PTCA VESSEL PERFORATION OCCURRED AND PTCA WAS DONE AGAIN. THE FLOW-PROCEDURE WAS TIMI 2. THE PHYSICIAN'S COMMENTS RAGARDING THE POSSIBLE CAUSE OF THE LATE THROMBOSIS WAS THAT IT MAY BE DUE TO: (1) THE STENT WAS UNDER-DILATED. (2) THERE REMAINED UNTREATED LESION DISTAL TO THE IMPLANTED CYPHER. (3) TICLOPIDINE HYDROCHLORIDE WAS STOPPED DUE TO RUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA I0106070

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R (1) HEPARIN| (3) ASPIRIN| (4) SARPOGRELATE HYDROCHLORIDE| (2) TICLOPIDINE HYDROCHLORIDE| 2.5/10 MM BALLOON CATHETER| 2.0/3. MM BALLOON CATHETER| (1) HEPARIN.| (2) TICLOPIDINE HYDROCHLORIDE| (1) HEPARIN| (3) ASPIRIN| (2) TICLOPIDINE HYDROCHLORIDE| (1) HEPARIN