BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2082630 · Received May 10, 2011

    Report

    Report Number
    9616099-2011-00315
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT DURING A PCI, DEFLATION OF THE BALLOON OF A CYPHER STENT DELIVERY SYSTEM (SDS) WAS VERY SLOW. THE TARGET LESION WAS THE LEFT MAIN TRUNK AND THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY ((B)(4)). THE LESION WAS A DE NOVO, SLIGHTLY CALCIFIED AND SLIGHTLY TORTUOUS. THERE WAS 90% STENOSIS. A BOSTON SCIENTIFIC INDEFLATOR WAS USED TO INFLATE THE BALLOON OF THE SDS. THE RATIO OF THE CONTRAST MEDIUM TO SALINE WAS 70% CONTRAST AND 30% SALINE, OR, 60% CONTRAST AND 40% SALINE. THE RECOMMENDED RATIO IS 1:1. THE CONTRAST USED IN THE PROCEDURE WAS LOPAMIDOL 370. INITIALLY, CYPHER SELECT+ (3.0/33 MM) WAS IMPLANTED AT THE DISTAL LEFT CIRCUMFLEX ((B)(4)) SUCCESSFULLY. THEN, A CYPHER BX (3.5/28 MM) WAS IMPLANTED AT 16 ATM AT THE TARGET WITHOUT PROBLEM. THERE WAS NO DIFFICULTY DELIVERING THE PRODUCT TO THE LESION. IT WAS UNKNOWN IF THE LESION WAS PRE-DILATED. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE (B)(4) IFU WARNS THAT PRIOR TO STENT PLACEMENTS, MAKE CERTAIN TO CARRY OUT PRE-DILATATION OF THE LESION. THE STENT WAS FULLY EXPANDED. IT WAS NOTED THAT THE "DEFLATION OF THE BALLOON WAS SLIGHTLY SLOW, BUT NOT FOR A VERY LONG TIME". THEN, TO CONDUCT POST-DILATION, THE SDS BALLOON WAS INSERTED INTO THE DEPLOYED STENT AND A BALLOON (3.0/15 MM: (B)(4)) WAS DELIVERED TO LCX BY KISSING BALLOON TECHNIQUE. THE BALLOONS WERE INFLATED AT 16 ATM WITHOUT PROBLEM, BUT THE DEFLATION OF THE SDS BALLOON, AGAIN WAS VERY SLOW. THE PHYSICIAN FELT THAT IT TOOK ALMOST A MINUTE. THE BALLOON WAS DEFLATED COMPLETELY AND THE SDS WAS REMOVED WITHOUT DIFFICULTY. (B)(4)WAS DEFLATED WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. ONE NON-STERILE CYPHER BX (B)(4) 3.5 X 30 MM WAS RECEIVED INSIDE TWO PLASTIC BAGS. THREE KINKS WERE DETECTED AT 9, 18.5, 25 CM. FROM THE DISTAL END; THIS CONDITION ON THE SHAFT COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. CRYSTALLIZED INFLATION RESIDUES WERE FOUND ALONG THE CATHETER; THE BALLOON WAS ALREADY INFLATED AND THE INNER BODY (BALLOON AREA) COULD BE OBSERVED ELONGATED. SEM RESULTS SHOWED THAT BOTH THE TRANSITION SEAL AND THE PROXIMAL SEAL PRESENTED NO EVIDENCE OF BLOCKAGE OR ANY OTHER ANOMALY THAT COULD BE RELATED TO THE REPORTED FAILURE. THE SAMPLE EXHIBITED NO EVIDENCE OF INTERNAL OR EXTERNAL SURFACE MATERIAL DAMAGE. DEFLATION/INFLATION TEST WAS EXECUTED; THE UNIT WAS INFLATED (16 ATM.) AND DEFLATED WITHOUT ANOMALIES. 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. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE REPORTED FAILURE, THE INNER BODY AND SHAFT CONDITION COULD NOT BE DETERMINED. HOWEVER, REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PROCEDURAL FACTORS (CONTRAST MEDIA TO SALINE RATIO) THAT MAY HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTY REPORTED. NEITHER THE DHR NOR THE PRODUCT ANALYSIS INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT DEVICES: GW: UNICORE, WHISPERMS, INTERMEDIATE; GC: XB3.5 6FR; BC: HIRYU 3.0/15MM; STENT: SELECT+ 3.0/33MM; BOSTON INDEFLATOR.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE AFFILIATE STATES THAT DEFLATION OF THE BALLOON OF THE CYPHER STENT DELIVERY SYSTEM (SDS) WAS VERY SLOW. THE PATIENT'S AGE WAS UNKNOWN BUT WAS A MALE. THE TARGET LESION WAS THE LEFT MAIN TRUNK AND THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (B)(6). THE LESION WAS A DE NOVO, SLIGHTLY CALCIFIED AND SLIGHTLY TORTUOUS. THERE WAS 90% STENOSIS. A BOSTON SCIENTIFIC INDEFLATOR WAS USED TO INFLATE THE BALLOON OF THE SDS. THE CONTRAST TO SALINE RATIO WAS 7:3 - 6:4. THE CONTRAST USED IN THE PROCEDURE WAS LOPAMIDOL 370. INITIALLY, CYPHER SELECT+ (3.0/33MM) WAS IMPLANTED AT THE DISTAL LEFT CIRCUMFLEX (B)(6) WITHOUT ANY PROBLEM. THEN, A CYPHER BX (3.5/28MM) WAS IMPLANTED AT 16ATM AT THE TARGET WITHOUT PROBLEM. THE STENT WAS FULLY EXPANDED. IT WAS NOTED THAT THE DEFLATION OF THE BALLOON WAS SLIGHTLY SLOW, BUT NOT FOR A VERY LONG TIME. THEN, TO CONDUCT POST-DILATION, THE SDS BALLOON WAS INSERTED INTO THE DEPLOYED STENT AND A BALLOON (3.0/15MM: HIRYU) WAS DELIVERED TO LCX BY KISSING BALLOON TECHNIQUE. THE BALLOONS WERE INFLATED AT 16ATM WITHOUT PROBLEM, BUT THE DEFLATION OF THE SDS BALLOON AGAIN WAS VERY SLOW. THE PHYSICIAN FELT THAT IT TOOK ALMOST A MINUTE. CONCLUSIVELY, THE BALLOON WAS DEFLATED COMPLETELY AND SO THE SDS WAS REMOVED PROPERLY. HIRYU WAS DEFLATED WITHOUT PROBLEM. BECAUSE THE STENT WAS IMPLANTED SAFELY, THE PROCEDURE WAS FINISHED. THERE WAS NO PATIENT INJURY REPORTED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE RATIO OF THE CONTRAST MEDIUM TO SALINE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 15055963

    Patients

    Seq Age Sex Outcome Treatment
    1