BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1052377 · Received March 18, 2008

    Report

    Report Number
    2024168-2008-00191
    Event Type
    Malfunction
    Date Received
    March 18, 2008
    Date of Event
    January 28, 2008
    Report Date
    January 31, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE STENT DELIVERY SYS (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON HAD LOOSE FOLDS. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. THERE WAS A BEND IN THE SHAFT 1 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PROD PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED RX VISION STENT DELIVERY SYS (SDS). IT WAS REPORTED THAT IN AN ATTEMPT TO CROSS THROUGH A CALCIFIED LESION, THE STENT DISLODGED PROXIMAL ONTO THE SHAFT OF THE SDS. THE DEVICE WAS REMOVED AND A BALLOON CATHETER WAS USED TO PERFORM ANGIOPLASTY. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. ADDITIONALLY, STENT DISLODGEMENT MAY BE CAUSED BY, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MFR, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL OR FORCED SHEATH REMOVAL, INTERACTION WITH OTHER DEVICES AND/OR ANATOMY, AND LESION MORPHOLOGY. ANALYSIS OF THE SDS CONFIRMED THAT THE STENT HAD DISLODGED AND WAS NOT RETURNED FOR EVAL. BLOOD IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN AND THE LOOSELY FOLDED BALLOON IS CONSISTENT WITH THE SDS BEING PREPARED FOR USE, INSERTED INTO THE BODY, AND THE BALLOON BEING AT LEAST PARTIALLY INFLATED. CRIMP MARKS WERE VISIBLE ON THE BALLOON AND BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MFR. ALL OUTLINE TESTING FOR THIS LOT IN QUESTION MET STENT MOVEMENT CRITERIA. THE LOT HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMING MATERIAL REPORTS ISSUED FOR THIS LOT THAT WERE RELATED TO THE REPORTED DISLODGED STENT. THE RELEASE TESTING DATA WAS ALSO REVIEWED. ALL SAMPLES FROM THIS LOT PASSED TESTING FOR STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER, AND STENT MOVEMENT, INDICATING THE UNITS HAD AN ADEQUATE CRIMP. THE REPORTED MODERATELY CALCIFIED LESION LIKELY CONTRIBUTED TO THE FAILURE TO CROSS AND THE STENT DISLODGEMENT. IN THIS CASE, WITH THE INFO PROVIDED AND THE ANALYSIS OF THE DEVICE, THE DIFFICULTIES APPEAR TO BE RELATED TO THE CIRCUMSTANCES OF THE PROCEDURE AND NOT A PROD QUALITY ISSUE. PROD PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. IN ADDITION, A BEND WAS NOTED IN THE SHAFT, WHICH WAS NOT REPORTED IN THE INCIDENT AND MAY HAVE OCCURRED DURING THE PACKAGING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVAL. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE PROFILE DIMENSIONS ON ALL CATHETERS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MFG LINE AT ABBOTT VASCULAR. ADDITIONALLY, ALL STENT DELIVERY SYS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND SECURITY. THIS MDR IS CONSIDERED CLOSED BY THE PROD PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE VISION DID NOT CROSS THE CALCIFIED RIGHT CORONARY ARTERY (RCA) LESION AND THE STENT HAD MOVED PROXIMAL ONTO THE SHAFT OF THE DEVICE. THE DEVICE WAS REMOVED FROM THE PT. THE STENT WAS DISCARDED. ONLY BALLOON ANGIOPLASTY WAS PERFORMED AT THAT LESION SITE. NO PT INJURY WAS REPORTED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    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 RX VISION 12| STENT: RX VISION 18| GUIDE WIRE: POWATER