BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 1073703 · Received July 1, 2008

    Report

    Report Number
    2024168-2008-00536
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 31, 2008
    Report Date
    June 2, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE PARTIAL DEFLATION OF THE BALLOON. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITHOUT BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE CRIMP MARKS VISIBLE ON THE BALLOON BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE SDS. THE OVERALL TOTAL LENGTH OF THE SDS WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR, FILLED WITH RENOGRAFIN-60 DILUTED 1:1 WITH WATER, WAS USED TO MEASURE THE DEFLATION TIMES AND THEY MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND RESULTS OF THE RETURNED DEVICE ANALYSIS. THE ANALYSIS OF THE RETURNED DEVICE DID NOT FIND ANY ISSUE WITH THE INFLATION AND DEFLATION OF THE BALLOON OF THE SDS. THREE MEASUREMENTS OF THE DEFLATION TIME OF THE RETURNED DEVICE FOUND THAT THE DEFLATION TIME MET MANUFACTURING CRITERIA. FACTORS THAT CAN AFFECT DIFFICULTY IN DEFLATING A BALLOON INCLUDE, BUT ARE NOT LIMITED TO BLOCKAGE IN INFLATION LUMEN, REDUCED ANNULAR SPACE, OR KINKED SHAFT. IN THIS CASE, THERE WAS NO QUALITY ISSUE FOUND WITH THE RETURNED DEVICE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE STENT IMPLANT WAS NOT RETURNED. THIS IS CONSISTENT WITH THE REPORTED STENT DEPLOYMENT. HOWEVER, THE ANALYSIS NOTED THAT THE BALLOON WAS STILL TIGHTLY FOLDED WITH PRESENCE OF CRIMP MARKS ON THE BALLOON, WHICH SUGGESTS THAT THE BALLOON MAY NOT HAVE BEEN INFLATED OR A WRONG DEVICE WAS RETURNED FOR ANALYSIS. A FOLLOW-UP BY THE QA ANALYST TO THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE WAS RETURNED TO ABBOTT VASCULAR. IT IS UNKNOWN WHY THE BALLOON WAS STILL TIGHTLY FOLDED WITH CRIMP MARKS STILL VERY EVIDENT ON IT. IT IS EXPECTED THAT THE BALLOON WILL APPEAR LOOSELY FOLDED WITH THE CRIMP MARKS BARELY APPARENT AFTER INFLATION AND DEFLATION. THIS WAS OBSERVED AFTER THE FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE. BASED ON THE INCIDENT INFORMATION AND RESULT OF THE RETURNED DEVICE ANALYSIS, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED COMPLAINT OF DIFFICULT TO DEFLATE. HOWEVER, THERE WAS NO INDICATION OF A QUALITY ISSUE WITH THE RETURNED DEVICE. IN ADDITION, THE LOT HISTORY RECORD REVIEW DID NOT INDICATE ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT AND A QUERY OF THE COMPLAINT-HANDLING DATABASE INDICATED THAT THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED WITH THIS PART NUMBER / LOT NUMBER COMBINATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: PARTIAL DEFLATION IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: PARTIAL DEFLATION. IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE POSTERIAL LATERAL AND THE VESSEL DIAMETER WAS 2.0 MM. THE PIXEL WAS INFLATED UP TO 6 ATM FOR 30 SECONDS AND THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE BALLOON DID NOT DEFLATE COMPLETELY (PARTIALLY DEFLATED). THE CATHETER WAS EVENTUALLY ABLE TO BE REMOVED FROM THE PATIENT BY CAREFULLY PULLING THE PIXEL INTO THE GUIDING CATHETER, AND ALL THE DEVICES WERE REMOVED OUT OF THE PATIENT IN ONE UNIT. IN VITRO, IT WAS ATTEMPTED TO INFLATE AND DEFLATE THE BALLOON AND IT THERE SEEMED TO BE NO PROBLEM. THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX PIXEL CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8040731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK