BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2091786 · Received May 17, 2011

    Report

    Report Number
    3003742446-2011-00254
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 5, 2010
    Report Date
    January 17, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES AFTER THE INDEX PROCEDURE AND LATER EXPERIENCED RESTENOSIS WITH LATE STENT MALAPPOSITION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, RENAL INSUFFICIENCY, BENIGN PROSTATIC HYPERTROPHY AND PAST SMOKER. THE TARGET LESION WAS THE MID AND DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DISTAL LAD WAS DESCRIBED AS DE NOVO AND 70% STENOSED. THE LESION WAS DIRECT STENTED WITH A 2.25MM X 13MM CYPHER RX AT 16 ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL RATE OF STENOSIS WAS 0%. THE MID LAD WAS DESCRIBED AS 80% STENOSED, 50MM IN LENGTH, DE NOVO AND ANATOMICALLY COMPLEX. THE LESION WAS PRE-DILATED WITH A 2.0 X 30MM BALLOON AT 16ATM FOLLOWED BY THE IMPLANT OF A 2.25 X 23MM CYPHER RX IMPLANTED IN THE DISTAL PORTION OF THE LESION AT 16ATM. THE STENT WAS NOT POST-DILATED. A 2.5 X 28MM CYPHER RX STENT WAS THEN IMPLANTED AT 18ATM PROXIMAL TO AND ABUTTING THE PREVIOUS STENT. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.0 X 15MM BALLOON AT 12ATM. THAT WAS FOLLOWED BY THE IMPLANT OF A 3.5 X 8MM CYPHER RX STENT AT 16ATM PROXIMAL TO AND ABUTTING THE PREVIOUS STENT. THE REPORTED RESIDUAL STENOSIS WAS 0%. IT WAS NOTED AFTER THE PROCEDURE THAT THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED, POST-PROCEDURE CK WAS 8000 (ULN 238 U/L), CK-MB WAS 4.3 (ULN 3.8 NG/ML) AND TROPONIN I WAS 0.34 (ULN 0.03 NG/ML). THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO TREATMENT FOR THE ELEVATED ENZYMES AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A POSITIVE ISCHEMIC FUNCTIONAL STUDY AND UNDERWENT REVASCULARIZATION OF THE MID LAD. IVUS SHOWED AN UNDER DEPLOYED 2.25 X 23 STENT IN THE MID LAD WITH ABOUT 60% STENOSIS. THE LESION WAS SUCCESSFULLY TREATED WITH A 2.75MM BALLOON WITH A REPORTED RESIDUAL STENOSIS OF 20%. IT WAS NOTED THAT THERE WAS 90% OSTIAL LESION IN THE 2ND DIAGONAL, BUT THERE WAS NO TREATMENT REPORTED FOR THAT LESION AND IT WAS NOT WITHIN 5MM OF THE RESTENOSIS. THE DEVICES WERE IMPLANTED AND, THEREFORE, NOT AVAILABLE FOR ANALYSIS. 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. ELEVATED CARDIAC ENZYMES, RESTENOSIS AND STENT MALAPPOSITION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. WHILE LATE STENT MALAPPOSITION HAS PREVIOUSLY BEEN ASSOCIATED WITH BIFURCATING LESIONS, PLAQUE DISTRIBUTION IN THE LESION AND BRACHYTHERAPY, REVIEW OF CURRENT LITERATURE DEMONSTRATES SOME AUTHORS SUGGEST DRUG-ELUTING STENTS MAY HAVE THE SAME POTENTIAL RISKS AS BRACHYTHERAPY, IN TERMS OF THE ANTI-PROLIFERATIVE EFFECTS ON VASCULAR SMOOTH MUSCLE CELLS AND ENDOTHELIAL CELLS. HOWEVER, WITH SUCH LIMITED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT, HOWEVER THE UNDER EXPANSION OF THE STENT SIX MONTHS POST-PROCEDURE MAY BE RELATED TO NOT BEING POST-DILATED AFTER IMPLANT. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00254 AND 3003742446-2011-00255.

    Additional Manufacturer Narrative · 1

    NEXT, A 3.5 X 8MM CYPHER RX WAS IMPLANTED AT 16ATM PROXIMAL TO AND ABUTTING THE PREVIOUS STENT. THE THREE STENTS FULLY COVERED THE MID LAD LESION WITH NO RESIDUAL STENOSIS. PRE AND POST PROCEDURE TIMI FLOW WAS 3. MAXIMUM POST-PROCEDURE CK WAS 8000 (ULN 238 U/L), CK-MB WAS 4.3 (ULN 3.8 NG/ML) AND TROPONIN I WAS 0.34 (ULN 0.03 NG/ML). THE PATIENT WAS ASYMPTOMATIC AND WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A POSITIVE ISCHEMIC FUNCTIONAL STUDY AND UNDERWENT REVASCULARIZATION OF THE MID LAD. IVUS SHOWED THAT THE PROXIMAL PORTION OF THE 2.25 X 23 STENT IN THE MID LAD WAS UNDER-DEPLOYED AND HAD ABOUT 60% RE-STENOSIS. THE LESION WAS SUCCESSFULLY TREATED WITH A 2.75MM BALLOON AND THERE WAS 20% RESIDUAL STENOSIS. IT WAS NOTED THAT THERE WAS 90% OSTIAL LESION IN THE 2ND DIAGONAL, BUT THERE WAS NO TREATMENT REPORTED FOR THAT LESION AND IT WAS NOT WITHIN 5MM OF THE RESTENOSIS. CONCOMITANT MEDICATIONS INCLUDED TEKTURNA 300MG DAILY SINCE 2008, BYSTOLIC 5MG DAILY SINCE (B)(6) 2010, ASPIRIN 81MG SINCE (B)(6) 2010, VYTORIN 10/20 DAILY SINCE (B)(6) 2010, FISH OIL DAILY SINCE (B)(6) 2010 AND CLOPIDOGREL 75MG SINCE (B)(6) 2010. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00254 AND 3003742446-2011-00255.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    UPDATED COMPLAINT CONCLUSION TO INCLUDE INFORMATION ABOUT SIDE BRANCH OCCLUSION. AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED ELEVATED CARDIAC ENZYMES AFTER THE INDEX PROCEDURE AND LATER EXPERIENCED RESTENOSIS WITH LATE STENT MALAPPOSITION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THESE EVENTS HAVE ALREADY BEEN CAPTURED AND REPORTED AS RESTENOSIS. ADDITIONAL INFORMATION RECEIVED INDICATES THAT A SIDE BRANCH OCCLUSION OCCURRED POST DEPLOYMENT OF ONE CYPHER STENT. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERLIPIDEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, RENAL INSUFFICIENCY, BENIGN PROSTATIC HYPERTROPHY AND PAST SMOKER. THE TARGET LESION WAS THE MID AND DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DISTAL LAD WAS DESCRIBED AS DE NOVO AND 70% STENOSED. THE LESION WAS DIRECT STENTED WITH A 2.25MM X 13MM CYPHER RX AT 16 ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL RATE OF STENOSIS WAS 0%. THE MID LAD WAS DESCRIBED AS 80% STENOSED, 50MM IN LENGTH, DE NOVO AND ANATOMICALLY COMPLEX. THE LESION WAS PRE-DILATED WITH A 2.0 X 30MM BALLOON AT 16ATM FOLLOWED BY THE IMPLANT OF A 2.25 X 23MM CYPHER RX IMPLANTED IN THE DISTAL PORTION OF THE LESION AT 16ATM. POST STENT DEPLOYMENT, SIDE BRANCH OCCLUSION OF THE SECOND DIAGONAL OCCURRED. THERE WAS 90% OCCLUSION AT THE BIFURCATION AND 10% RESIDUAL STENOSIS POST STENT DEPLOYMENT. THE STENT WAS NOT POST-DILATED. A 2.5 X 28MM CYPHER RX STENT WAS THEN IMPLANTED AT 18ATM PROXIMAL TO AND ABUTTING THE PREVIOUS STENT. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.0 X 15MM BALLOON AT 12ATM. THAT WAS FOLLOWED BY THE IMPLANT OF A 3.5 X 8MM CYPHER RX STENT AT 16ATM PROXIMAL TO AND ABUTTING THE PREVIOUS STENT. THE REPORTED RESIDUAL STENOSIS WAS 0%. IT WAS NOTED AFTER THE PROCEDURE THAT THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED, POST-PROCEDURE CK WAS 8000 (ULN 238 U/L), CK-MB WAS 4.3 (ULN 3.8 NG/ML) AND TROPONIN I WAS 0.34 (ULN 0.03 NG/ML). THE PATIENT WAS ASYMPTOMATIC. THERE WAS NO TREATMENT FOR THE ELEVATED ENZYMES AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT HAD A POSITIVE ISCHEMIC FUNCTIONAL STUDY AND UNDERWENT REVASCULARIZATION OF THE MID LAD. IVUS SHOWED AN UNDER DEPLOYED 2.25 X 23 STENT IN THE MID LAD WITH ABOUT 60% STENOSIS. THE LESION WAS SUCCESSFULLY TREATED WITH A 2.75MM BALLOON WITH A REPORTED RESIDUAL STENOSIS OF 20%. IT WAS NOTED THAT THERE WAS 90% OSTIAL LESION IN THE 2ND DIAGONAL, BUT THERE WAS NO TREATMENT REPORTED FOR THAT LESION AND IT WAS NOT WITHIN 5MM OF THE RESTENOSIS. 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. ELEVATED CARDIAC ENZYMES, RESTENOSIS AND STENT MALAPPOSITION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM. THIS ACTION (INHERENT RISK OF THE PROCEDURE) IN ADDITION TO THE SIDE BRANCH OCCLUSION MAY HAVE CONTRIBUTED TO THE ELEVATED ENZYMES POST PROCEDURE. WHILE LATE STENT MALAPPOSITION HAS PREVIOUSLY BEEN ASSOCIATED WITH BIFURCATING LESIONS, PLAQUE DISTRIBUTION IN THE LESION AND BRACHYTHERAPY, REVIEW OF CURRENT LITERATURE DEMONSTRATES SOME AUTHORS SUGGEST DRUG-ELUTING STENTS MAY HAVE THE SAME POTENTIAL RISKS AS BRACHYTHERAPY, IN TERMS OF THE ANTI-PROLIFERATIVE EFFECTS ON VASCULAR SMOOTH MUSCLE CELLS AND ENDOTHELIAL CELLS. HOWEVER, WITH SUCH LIMITED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WITH ANY CERTAINTY WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT, HOWEVER THE UNDER EXPANSION OF THE STENT SIX MONTHS POST-PROCEDURE MAY BE RELATED TO NOT BEING POST-DILATED AFTER IMPLANT. THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00254 AND 3003742446-2011-00255.

    Description of Event or Problem · 1

    INFORMATION RECEIVED ON (B)(6) 2011 FROM THE (B)(6) MINUTES REVEALED THAT AT THE TIME OF THE INDEX PROCEDURE, THE 2ND DIAGONAL WAS 10% STENOSED PRE-PROCEDURE AND WAS 90% STENOSED POST-PROCEDURE AT THE BIFURCATION. ACCORDING TO THE INVESTIGATIONAL SITE PERSONNEL, THIS WAS CAUSED BY THE 2.25 X 23MM STENT. THERE WAS NO TREATMENT FOR THE OCCLUSION.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT HAD A POSITIVE FUNCTIONAL TEST FOR ISCHEMIA AND UNDERWENT REVASCULARIZATION OF THE TARGET LESION DUE TO RESTENOSIS AND STENT UNDER-EXPANSION APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT HAD LESIONS IN THE MID AND DISTAL LEFT ANTERIOR DESCENDING (LAD). THE INDICATION FOR THE INDEX PROCEDURE WAS SEVERE DYSPNEA ON EXERTION. THE DISTAL LAD LESION WAS DE NOVO, 8MM IN LENGTH, CLASS A AND 70% STENOSED. THE REFERENCE VESSEL WAS 2.25MM IN DIAMETER. A 2.25 X 13MM CYPHER RX WAS IMPLANTED AT 16ATM BY DIRECT STENTING. THE STENT WAS NOT POST-DILATED AND THERE WAS NO RESIDUAL STENOSIS. PRE AND POST TIMI FLOW WAS 3. THE MID LAD WAS 80% STENOSED, 50MM IN LENGTH AND CLASS C. THE REFERENCE VESSEL WAS 3.5MM IN DIAMETER. THE LESION WAS PRE-DILATED WITH A 2.0 X 30MM BALLOON AT 16ATM. A 2.25 X 23MM CYPHER RX WAS IMPLANTED IN THE DISTAL PORTION OF THE LESION AT 16ATM AND WAS NOT POST-DILATED. NEXT, A 2.5 X 28MM CYPHER RX WAS IMPLANTED AT 18ATM PROXIMAL TO AND ABUTTING THE PREVIOUS STENT. THE STENT WAS POST-DILATED PER STANDARD PROCEDURE WITH A 3.0 X 15MM BALLOON AT 12ATM.

    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 15107478

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R