BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1013992 · Received March 13, 2008

    Report

    Report Number
    2024168-2008-00183
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS CODE: PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE DISLODGED STENT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND ON THE INSIDE OF THE SOFT TIP. THERE WAS NO CONTRAST VISIBLE. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS. THE BALLOON WAS TIGHTLY FOLDED. THERE WAS NO DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND RESULTS OF THE ANALYSIS. THE SDS WAS RETURNED WITHOUT THE STENT IMPLANT CONFIRMING THE REPORTED COMPLAINT OF MISSING STENT. HOWEVER, THE PRESENCE OF CRIMP MARKS ON THE TIGHTLY FOLDED BALLOON INDICATES THAT THE STENT WAS AT LEAST CRIMPED ONTO THE BALLOON AT THE TIME OF MANUFACTURING. THIS SUGGESTS THAT THE ANOMALY IS STENT DISLODGEMENT INSTEAD OF MISSING STENT AS REPORTED. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS: "PRIOR TO USING THE GUIDANT MULTI-LINK VISION RX OR GUIDANT MULTI-LINK VISION OTW CORONARY STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED." IN THIS INSTANCE, THE SDS WAS RETURNED WITH BLOOD ON THE BALLOON AND INSIDE THE SOFT TIP, WHICH IS CONSISTENT WITH THE REPORTED ADVANCEMENT OF THE SDS INSIDE THE PATIENT. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURING. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL REPORTS. ADDITIONALLY, A QUERY OF THE COMPLAINT- HANDLING DATABASE INDICATED THAT THERE HAS BEEN NO SIMILAR COMPLAINTS REPORTED FOR BOTH THE ORIGINAL AND REWORK LOT. ALL QUALITY PARAMETERS INCLUDING STENT PLACEMENT AND STENT MOVEMENT WERE WITHIN SPECIFICATION ON THE LOTS RELEASE TEST SAMPLES. BASED ON THE INCIDENT INFORMATION AND RESULTS OF THE ANALYSIS OF THE RETURNED SDS, WITHOUT THE STENT IMPLANT AND THE PROTECTIVE SHEATH, A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT CANNOT BE DETERMINED, BUT THERE IS NO INDICATION OF A QUALITY ISSUE. A CONCLUSIVE ROOT CAUSE FOR THE DISLODGED STENT COULD NOT BE DETERMINED. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT WAS MISSING FROM THE 4.0 X 08 VISION STENT DELIVERY SYSTEM (SDS) WHEN THE SDS WAS REMOVED FROM THE PACKAGE. THE TECHNICIAN NOTED THAT THE STENT WAS MISSING PRIOR TO USE. HOWEVER, THE PHYSICIAN INSISTED THE STENT WAS PRESENT ON THE SDS AND USED IT FOR THE PROCEDURE. UPON ADVANCEMENT OF THE SDS, THE PHYSICIAN REALIZED THAT THERE WAS NO STENT ON THE SDS. THEREFORE, THE SDS WAS REMOVED AND ANOTHER VISION STENT WAS USED TO COMPLETE THE PROCEDURE. DESPITE EVERY ATTEMPT TO FIND THE STENT BY LOOKING THROUGH THE PACKAGING, THE BACKTABLE AND ON THE FLOOR THE STENT IMPLANT WAS NEVER FOUND. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THIS EVENT IS BEING FILED BASED ON THE ANALYSIS OF THE RETURNED SDS WHICH REVEALED CRIMP MARKS ON THE BALLOON, INDICATING THAT A STENT WAS ORIGINALLY CRIMPED ON THE BALLOON AND DISLODGED DURING UNPACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 7101731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK