BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1920637 · Received December 13, 2010

    Report

    Report Number
    3003742446-2010-00449
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES INCLUDE A 3.2X20MM DURASTAR PTCA DILATION CATHETER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. ADDENDUM: CARDIAC CATHETERIZATION REPORT REVEALED THE RIGHT CORONARY ARTERY HAD A BARE METAL STENT IMPLANTED IN 2001 AND A 3.0X28 CYPHER STENT IMPLANTED IN (B)(6) 2010 FOR IN-STENT RESTENOSIS. RESULTS INDICATED THERE WAS SEVERE REPEAT IN-STENT RESTENOSIS OF THE PROXIMAL TO MID RCA. THERE WAS A TIMI FLOW DOWN THE REST OF THE CORONARY ARTERY. THE STENT STENOSIS WAS GRADED AT BETTER THAN 95%. PER THE CARDIAC CATHETERIZATION REPORT, TREATMENT INCLUDED AGGRESSIVE MEDICAL THERAPY WITH CONSIDERATION FOR CORONARY ARTERY BYPASS GRAFTING IF THE PATIENT FAILED. THE STUDY COORDINATOR CONFIRMED THAT THE BARE METAL STENT WAS A BX VELOCITY STENT IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY IN 2001. MEDICAL THERAPY INCLUDED LASIX, IMDUR, AND AN INCREASE IN METOPROLOL DOSE. THE EVENT RESOLVED WITHOUT SEQUELAE. 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 15077894 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT EXPERIENCED IN-STENT RESTENOSIS APPROXIMATELY EIGHT MONTHS POST INDEX PROCEDURE. THIS IS A (B)(6) FEMALE WITH MEDICAL HISTORY INCLUDING ANGINA, PREVIOUS PERCUTANEOUS CORONARY INTERVENTION WITH BARE METAL STENT PLACEMENT IN 2001, HYPERTENSION, HYPERLIPIDEMIA, CONGESTIVE HEART FAILURE, MITRAL REGURGITATION, TYPE 2 DIABETES MELLITUS, IODINE ALLERGY, AND SILK TAPE ALLERGY. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF A BX VELOCITY STENT. THE LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS 80% STENOSED, NON-THROMBOSED, 20MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.2X20MM DURA STAR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATION CATHETER AT 10ATMS. A 3.0X28MM CYPHER STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 3.25X20MM BALLOON CATHETER AT 18ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. APPROXIMATELY EIGHT MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN LASTING TWENTY-FIVE MINUTES NOT RELIEVED WITH NITROGLYCERIN. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AND SUBSEQUENTLY UNDERWENT CARDIAC CATHETERIZATION THAT REVEALED 95% IN-STENT RESTENOSIS WITH COLLATERAL FILLING OF THE CYPHER STENT. THIS WAS SEEN IN THE PROXIMAL TO MID RCA. THE EVENT WAS MEDICALLY MANAGED. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO CORDIS PRODUCT. ADDENDUM: CARDIAC CATHETERIZATION REPORT REVEALED THE RIGHT CORONARY ARTERY HAD A BARE METAL STENT IMPLANTED IN 2001 AND A 3.0X28 CYPHER STENT IMPLANTED IN (B)(6) 2010 FOR IN-STENT RESTENOSIS. RESULTS INDICATED THERE WAS SEVERE REPEAT IN-STENT RESTENOSIS OF THE PROXIMAL TO MID RCA. THERE WAS A TIMI FLOW DOWN THE REST OF THE CORONARY ARTERY. THE STENT STENOSIS WAS GRADED AT BETTER THAN 95%. PER THE CARDIAC CATHETERIZATION REPORT, TREATMENT INCLUDED AGGRESSIVE MEDICAL THERAPY WITH CONSIDERATION FOR CORONARY ARTERY BYPASS GRAFTING IF THE PATIENT FAILED. MEDICAL THERAPY INCLUDED LASIX, IMDUR, AND AN INCREASE IN METOPROLOL DOSE. THE EVENT RESOLVED WITHOUT SEQUELAE. 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 15077894 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTION FOR USE (IFU). IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRA-STENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND DIABETES.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS OF THE CYPHER STENT APPROXIMATELY EIGHT MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF AN UNKNOWN DRUG-ELUTING STENT. THE LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS DESCRIBED AS 80% STENOSED, NON-THROMBOSED, 20MM IN LENGTH, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A 3.2X20MM DURA STAR PTCA DILATION CATHETER AT 10ATMS. A 3.0X28MM CYPHER STENT WAS SUCCESSFULLY IMPLANTED AT 18ATMS. POST-DILATION WAS PERFORMED WITH AN UNKNOWN 3.25X20MM BALLOON CATHETER AT 18ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. EIGHT MONTHS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN LASTING TWENTY-FIVE MINUTES NOT RELIEVED WITH NITROGLYCERIN. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT AND SUBSEQUENTLY UNDERWENT CARDIAC CATHETERIZATION THAT REVEALED 95% IN-STENT RESTENOSIS WITH COLLATERAL FILLING OF THE CYPHER STENT. THIS WAS SEEN IN THE PROXIMAL TO MID RCA. THE EVENT WAS MEDICALLY MANAGED. THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO CORDIS PRODUCT.

    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) 15077894

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention