BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1973686 · Received January 31, 2011

    Report

    Report Number
    9616099-2011-00063
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    December 3, 2010
    Report Date
    March 2, 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

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    AFTER PREDILATION, THERE WAS FRICTION DURING DELIVERY OF THE 2.5X8 CYPHER SELECT PLUS DUE TO CALCIFICATION AND AFTER DELIVERY OF THE DEVICE, THE BALLOON OF THE SDS RUPTURED WITH THE SECOND INFLATION. THE SDS WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FURTHER POST DILATION USING ANOTHER BALLOON CATHETER. THERE WAS NO PATIENT INJURY. THE TARGET LESION WAS THE MID TO DISTAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS DE-NOVO, HEAVILY CALCIFIED AND MODERATELY TORTUOUS. PRE-PROCEDURE STENOSIS WAS 99%. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED WITH A BALLOON CATHETER (APEX: 2.0/10 MM) TWO OR THREE TIMES. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE DEVICE PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE CONTRAST TO SALINE RATIO WAS 1:1. A MEDTRONIC INDEFLATOR WAS USED FOR THE PROCEDURE. THE INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES. AFTER PREDILATION THE PHYSICIAN MANAGED TO DELIVER THE CYPHER SELECT PLUS ((B)(4)) TO THE TARGET LESION, ALTHOUGH THERE WAS FRICTION DUE TO CALCIFICATION AT THE PROXIMAL PORTION OF THE MID LAD, THE SDS OF THE CYPHER WAS INFLATED AT 12 ATM FOR 30 SEC AND THEN WAS INFLATED AGAIN UP TO 12-14 ATM, BUT THE BALLOON RUPTURED. BALLOON RUPTURE WAS CONFIRMED BY BACK-FLOW OF BLOOD INTO THE INFLATION DEVICE. THEREFORE, THE SDS OF THE CYPHER SELECT+ WAS RETRIEVED FROM THE PATIENT AND POST-DILATION WAS CONDUCTED WITH ANOTHER BALLOON CATHETER (HIRYU: 2.5/10 MM) TO FURTHER DILATE THE CYPHER SELECT+ STENT. THE SDS WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED AT THE HOSPITAL. 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 15131142 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FUNCTIONAL TESTS (MULTIPLE INFLATION AND BURST) AS WELL AS RESULTS FOR LEAK TEST AND 100% INSPECTION WERE REVIEWED AND NO ANOMALIES WERE FOUND. NO DEFINITIVE CONCLUSION CAN BE MADE WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS; HOWEVER, BASED ON THE REPORTED INFORMATION, IT APPEARS THAT THE CALCIFIED LESION CHARACTERISTICS CONTRIBUTED TO THE REPORTED BALLOON BURST. WITH REVIEW OF THE DEVICE HISTORY RECORDS AND THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. PROCEDURAL/CLINICAL FACTORS APPEAR TO HAVE CONTRIBUTED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S AGE AND GENDER WERE UNKNOWN. THE TARGET LESION WAS THE MID TO DISTAL LAD. THE LESION WAS DE-NOVO, HEAVILY CALCIFIED AND MODERATELY TORTUOUS. PRE-PROCEDURE STENOSIS WAS 99%. FEMORAL APPROACH WAS CHOSEN FOR THE PROCEDURE. PRE-DILATION WAS CONDUCTED WITH A BALLOON CATHETER (APEX: 2.0/10MM) TWO OR THREE TIMES. THEN, THE PHYSICIAN MANAGED TO DELIVER A CYPHER SELECT PLUS (2.5/8MM: COMPLAINT PRODUCT) TO THE TARGET LESION, ALTHOUGH THERE WAS FRICTION DUE TO CALCIFICATION AT THE PROXIMAL PORTION OF THE MID LAD, THE SDS OF THE CYPHER SELECT+ WAS INFLATED AT 12ATM FOR 30SEC AND THEN WAS INFLATED AGAIN UP TO 12-14ATM, BUT THE BALLOON RUPTURED. BALLOON RUPTURE WAS CONFIRMED BY BACK-FLOW OF BLOOD INTO THE INFLATION DEVICE. THEREFORE, THE SDS OF THE CYPHER SELECT+ WAS RETRIEVED FROM THE PATIENT AND POST-DILATION WAS CONDUCTED WITH ANOTHER BALLOON CATHETER (HIRYU: 2.5/10MM) TO FURTHER DILATE THE CYPHER SELECT+ STENT. THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. THE SDS WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS DISCARDED AT THE HOSPITAL. THE PHYSICIAN DID NOT INDICATE ANY ANOMALIES PRIOR TO USE. THE DEVICE PREPPED NORMALLY AND WAS ABLE TO MAINTAIN NEGATIVE PRESSURE. THE CONTRAST TO SALINE RATIO WAS 1:1. A MEDTRONIC INDEFLATOR WAS USED FOR THE PROCEDURE. THE INDEFLATOR WAS SUCCESSFULLY USED WITH OTHER DEVICES.

    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 15131142

    Patients

    Seq Age Sex Outcome Treatment
    1 MEDTRONIC INFLATION DEVICE