BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2132190 · Received June 17, 2011

    Report

    Report Number
    3003742446-2011-00308
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 23, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INVESTIGATOR, THE STENT FRACTURE WAS PROBABLY RELATED TO THE INDEX PROCEDURE AND POSSIBLY THE CYPHER STENT. CONCOMITANT MEDICATIONS: HYDROCHLOROTHIAZIDE SINCE (B)(6) 2009, ZOCOR 20MG DAILY SINCE (B)(6) 2009, METOPROLOL 25MG SINCE (B)(6) 2009, ASPIRIN 81MG DAILY SINCE (B)(6) 2010, CLOPIDOGREL 75MG SINCE (B)(6) 2009. CONCOMITANT DEVICES: 3.0 X 23MM CYPHER RX, 3.0 X 8MM CYPHER RX. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00308 AND 3003742446-2011-00309.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION INCLUDING REVIEW OF FILMS: INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A DISSECTION, RESTENOSIS AND STENT FRACTURE AFTER HAVING CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, HYPERLIPIDEMIA, HYPERTENSION LVEF 40 TO 50%, SMOKING WITHIN 30 DAYS OF INDEX PROCEDURE, CYST REMOVAL OF LEFT CHECK, CYST OF THIRD DIGIT OF RIGHT HAND, AND GASTRO-ESOPHAGEAL REFLUX DISEASE. THE INDICATION FOR THE PROCEDURE WAS ANGINA. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS 80% STENOSED, DE NOVO, AND 20MM IN LENGTH AND MILDLY TORTUOUS. THE LESION WAS DIRECT STENTED WITH A 3.0 X 23MM CYPHER RX STENT AT 22 ATMS. AN EDGE DISSECTION OCCURRED, PROXIMAL AND DISTAL, AND A 2.5 X 13MM CYPHER RX WAS IMPLANTED AT 22ATM DISTAL TO THE INITIAL STENT AND WAS POST-DILATED WITH THE DELIVERY BALLOON AND A 3.0 X 8MM CYPHER RX WAS IMPLANTED AT 22 ATM PROXIMAL TO THE INITIAL STENT AND WAS POST-DILATED WITH THE DELIVERY BALLOON. THE ADDITIONAL STENTS TREATED THE DISSECTION. THERE WAS NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. SEVENTEEN MONTHS LATER, THE PATIENT EXPERIENCED SEVERE ANGINA, AND ANGIOGRAPHY REVEALED A STENT FRACTURE OF THE INITIALLY IMPLANTED STENT IN THE AREA WHERE IT WAS OVERLAPPING WITH THE DISTAL STENT AND RESTENOSIS THREE DAYS LATER. THE FRACTURE WAS TREATED WITH A 2.75 X 12MM PROMUS STENT. ACCORDING TO THE INVESTIGATOR, THE STENT FRACTURE WAS PROBABLY RELATED TO THE INDEX PROCEDURE AND POSSIBLY THE CYPHER STENT. A PROCEDURAL CD WAS SENT OUT FOR INDEPENDENT REVIEW AND INDICATED THE FOLLOWING: THE INDEX LESION WAS A DIFFUSELY DISEASED SMALL CALIBER VESSEL. WHEN THE FIRST STENT WAS IMPLANTED, A PROXIMAL AND DISTAL EDGE DISSECTION OCCURRED, WHICH WAS TREATED WITH THE IMPLANT OF TWO OTHER STENTS. AT THE FOLLOW UP PROCEDURE, STENT FRACTURE WAS NOTED AND TREATED WITH A 2.75MM X 12MM PROMO STENT. ACCORDING TO THE REVIEWER OF NOTE, THERE WAS A MODERATE TO SEVERE DEGREE OF IN-STENT RE-STENOSIS AND MILD SEPARATION OF THE FRACTURED SEGMENTS. IT IS THE OPINION OF THE REVIEWER THAT THIS PATIENT HAD STENTING OF THE MID LAD, INTRAVASCULAR ULTRASOUND WAS NOT CARRIED OUT AND THE SEGMENTS WERE ACUTELY STRAIGHTENED BY THE STENTS AND I BELIEVE THESE ARE THE MECHANICAL FORCES THAT LEAD TO THE FRACTURE OF THE STENTS AND THE RESULTING RESTENOSIS. THE REVIEWER ALSO INDICATES THAT THERE WAS RESIDUAL DISEASE AT THE INDEX PROCEDURE THAT LEAD TO SPASM OR DISSECTIONS OF THE PROXIMAL AND DISTAL ENDS OF THE INDEX STENT. 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. DISSECTION, RESTENOSIS AND STENT FRACTURE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE INFORMATION PROVIDED FROM THE INVESTIGATOR AND THE REPORT FROM THE INDEPENDENT REVIEWER, THERE APPEARS TO BE VESSEL/LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00308 AND 3003742446-2011-00309.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A DISSECTION OCCURRED DURING THE INDEX PROCEDURE AND APPROXIMATELY 17 MONTHS AFTER THE INDEX PROCEDURE, A PATIENT EXPERIENCED SEVERE ANGINA AND ANGIOGRAPHY REVEALED A STENT FRACTURE AND RESTENOSIS. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS 20MM IN LENGTH, AND DE NOVO. THE REFERENCE VESSEL WAS 2.75MM IN DIAMETER AND MILDLY TORTUOUS. A 3.0 X 23MM CYPHER RX WAS IMPLANTED AT 22ATM BY DIRECT STENTING. AN EDGE DISSECTION OCCURRED AND A 2.5 X 13MM CYPHER RX WAS IMPLANTED AT 22ATM DISTAL TO THE INITIAL STENT AND WAS POST-DILATED WITH THE DELIVERY BALLOON AND A 3.0 X 8MM CYPHER RX WAS IMPLANTED AT 22 ATM PROXIMAL TO THE INITIAL STENT AND WAS POST-DILATED WITH THE DELIVERY BALLOON. THE ADDITIONAL STENTS TREATED THE DISSECTION AND THE TOTAL STENTED SEGMENT WAS 40MM IN LENGTH. IVUS WAS NOT PERFORMED. THERE WAS NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. SEVENTEEN MONTHS LATER, THE PATIENT EXPERIENCED SEVERE ANGINA AND ANGIOGRAPHY REVEALED A STENT FRACTURE OF THE INITIALLY IMPLANTED STENT IN THE AREA WHERE IT WAS OVERLAPPING WITH THE DISTAL STENT AND RESTENOSIS THREE DAYS LATER. THE STENTS HAD BEEN IMPLANTED IN AN ACTIVELY MOVING SEGMENT OF THE ARTERY. THE STENT WAS NOT SEPARATED AT THE AREA OF FRACTURE. THE FRACTURE WAS TREATED WITH A 2.75 X 12MM PROMUS STENT.

    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 15042363

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention