BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1895111 · Received November 10, 2010

    Report

    Report Number
    3003742446-2010-00407
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    April 7, 2010
    Report Date
    May 19, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS AT THE TIME OF THE DISSECTION: HEPARIN INTRA-PROCEDURE, INTEGRILIN INTRA-PROCEDURE, DIOVAN HCT 320/25 DAILY, LIPITOR 40MG DAILY, TOPROL XL ER 25MG DAILY, AMARYL 1MG DAILY, ASPIRIN 325MG DAILY, CLINIDINE HCL 0.1MG THREE TIMES DAILY, PEPCID 20MG DAILY, FISH OIL 1000MG DAILY, METFORMIN 500MG TWICE DAILY, POTASSIUM 20MEQ DAILY, ONGLYZA 5MG DAILY, GLIPIZIDE ER 2.5MG DAILY, LASIX 20MG DAILY, CLOPIDOGREL 75 MG DAILY. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE CORRECT DATE OF EVENT WAS (B)(6) 2010. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A CORONARY ARTERY DISSECTION DURING THE PROCEDURE. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, PREVIOUS PCI, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, LVEF > 50%, PVD/CLAUDICATION AND TYPE II DIABETES MELLITUS, AND AN UNSPECIFIED CARDIAC ARRHYTHMIA. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA/ACUTE CORONARY SYNDROME. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS 80% STENOSED, DE NOVO, 22MM IN LENGTH AND A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS PRE-DILATED PRIOR TO THE ADVANCEMENT OF A 2.5MM X 18MM CYPHER STENT, BUT THE STENT COULD NOT CROSS THE LESION. THE LESION WAS AGAIN PRE-DILATED AND THE STENT WAS REINTRODUCED AND IMPLANTED AT THE TARGET LESION. A TYPE A EDGE DISSECTION WAS NOTED AFTER IMPLANT AND WAS TREATED WITH THE IMPLANT OF A 2.25MM X 8MM CYPHER STENT PROXIMAL AND OVERLAPPING THE FIRST. THE STENTS WERE POST-DILATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CORONARY ARTERY DISSECTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE EVENT, OTHER THAN THE INHERENT RISK ASSOCIATED WITH THE PROCEDURE. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: CEC ADJUDICATION MINUTES WERE REVIEWED. THE COMMITTEE DISAGREED WITH THE CODING OF MI (PROTOCOL DEFINITION) AND STENT THROMBOSIS (BOTH PROTOCOL AND ARC DEFINITIONS). THIS IS IN ACCORDANCE WITH THE FILE AS IT STANDS. THE COMMITTEE AGREED WITH THE CODING OF AND ARC (PERI-PROCEDURAL PCI). THIS EVENT WAS PREVIOUSLY CAPTURED AS AN ELEVATED CARDIAC ENZYME EVENT. THE FILE WILL BE UPDATED WITH REMOVAL OF THE ENZYME CODE AND A CODE FOR MI WILL BE ADDED AND THE FILE PROCESSED ACCORDINGLY. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #(B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS CYPRESS STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI AND AN ARTERIAL DISSECTION DURING THE INDEX PROCEDURE. THIS IS AN (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING MI WITH PCI (B)(6) 2010, DYSLIPIDEMIA, HYPERTENSION, PVD AND DIABETES. THE INDICATION FOR THE INDEX PROCEDURE WAS A POSITIVE FUNCTIONAL STUDY AND ANGINA. ANGIOGRAPHY REVEALED AN 80% STENOSIS IN THE MID LAD. IN (B)(6) 2010, THE INDEX PROCEDURE WAS PERFORMED FOR TREATMENT OF ONE TARGET LESION. PRE-DILATION AND SINGLE STENT IMPLANTATION WERE SUCCESSFULLY COMPLETED. THE SITE REPORTED AN EDGE DISSECTION AT THE DISTAL EDGE AND AN ADDITIONAL STUDY STENT WAS IMPLANTED IN AN OVER LAPPING FASHION SUCCESSFULLY. THE CORE LAB REPORTED A 18% RESIDUAL STENOSIS, NO DISSECTION AND TIMI 3 FLOW. PRE-PROCEDURE NO CARDIAC ENZYMES WERE DRAWN. POST-PROCEDURE THE CK WAS 46, THE CKMB WAS NOT TESTED AND THE TROPONIN WAS 0.38. THE NEXT SET OF ENZYMES REVEALED A CK OF 51, A CKMB WAS NOT DONE AND TROPONIN OF 0.35. THE CEC COMMITTEE HAS DEEMED THIS ENZYME ELEVATION AS AN ARC PERI-PROCEDURAL PCI THUS THE FILE HAS BEEN CODED FOR MI. ADDITIONAL SOURCE DOCUMENTATION WAS REQUESTED FROM THE SITE; HOWEVER, THE SITE RESPONDED "REVIEWED BY PI. NO PERI-PROCEDURAL MI EXPERIENCED. NO SOURCE WILL BE SENT." THE PATIENT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE ON DUAL ANTI-PLATELET THERAPY. THE STUDY STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. PI#: 1-C6UVUX: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15095734 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION 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 SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. 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 ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL, LESION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #3003742446-2010-00407 AND #3003742446-2012-00175.

    Description of Event or Problem · 1

    AS REPORTED VIA (B)(4) STUDY, A PATIENT EXPERIENCED A VESSEL DISSECTION DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DE NOVO AND 22MM IN LENGTH. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER. PRE-PROCEDURE TIMI FLOW WAS II AND THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA/ACUTE CORONARY SYNDROME. THE LESION WAS PRE-DILATED WITH A NON-CORDIS 2.5 X 12MM BALLOON AT 14ATM. A 2.5 X 18MM CYPHER RX WAS ADVANCED TO THE LESION, BUT COULD NOT CROSS AND WAS REMOVED FROM THE PATIENT. THE LESION WAS PRE-DILATED AGAIN, AND THE STENT WAS REINSERTED AND IMPLANTED AT THE TARGET LESION. DUE TO A TYPE A EDGE DISSECTION THAT WAS NOTED AFTER STENT IMPLANTATION, A 2.25 X 18MM CYPHER RX WAS IMPLANTED PROXIMAL TO THE FIRST CYPHER WITH OVERLAP TO SUCCESSFULLY TREAT THE DISSECTION. THERE WAS NO OTHER INJURY TO THE PATIENT. THE STENTS WERE POST-DILATED WITH A 2.5 X 12MM BALLOON AT 20ATM. THE PATIENT WAS DISCHARGED APPROXIMATELY TWO DAYS AFTER THE INDEX PROCEDURE.

    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 15095734

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention