BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2052204 · Received April 12, 2011

    Report

    Report Number
    2024168-2011-02574
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND MID LEFT CIRCUMFLEX (LCX) ARE TREATED WITH STENT IMPLANTS. THE LAD AND DIAGONAL ARE THEN WIRED. THE OSTIUM OF THE DIAGONAL (EXTENDING INTO THE LAD) IS PRE-DILATED AND STENTED. THE STENT SHADOW IS VERY FAINT, BUT THE PROXIMAL EDGE DOES APPEAR TO EXTEND INTO THE LAD. A BALLOON DILATATION OCCURS THEN AT A LESION SITE IN THE MID-LAD, BELOW THE STENTED DIAGONAL BRANCH. ANOTHER DILATATION OCCURS IN THE LAD JUST PROXIMAL TO THE DIAGONAL BRANCH. THE NEXT RUN SHOWS A FAINT RADIOPACITY AT THE BIFURCATION SITE. THERE ARE TWO CATHETER MARKERS VISIBLE; ONE IN THE PROXIMAL LAD AND ONE IN THE GUIDE CATHETER. THE GUIDE WIRE IS REMOVED FROM THE CATHETER. A GUIDE WIRE IS THEN POSITIONED IN THE LAD OUTSIDE OF THE BALLOON CATHETER. A STENT IS POSITIONED AND DEPLOYED OVER THE LENGTH OF THE BALLOON MARKERS. ANOTHER STENT IS THEN DEPLOYED OVER THE MID LAD LESION. FINAL IMAGES SHOW THAT THE BALLOON MARKERS ARE STILL VISIBLE PROXIMAL TO THE DIAGONAL BRANCH. THE FAINT RADIOPACITY IS STILL VISIBLE AT THE POINT OF BIFURCATION. THE REVIEWER CONCLUDED THAT THE IMAGES SUGGEST THAT THE STENT DISLODGED IN THE LAD AT THE BIFURCATION OF THE DIAGONAL AND THAT THE BALLOON SEPARATED FROM THE SHAFT. THE BALLOON WAS STENT-CRUSHED AGAINST THE VESSEL WALL AND REMAINS IN THE BODY. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IT WAS REPORTED THE VISION SDS INTERACTED WITH THE PROXIMAL PORTION OF THE PREVIOUSLY PLACED XIENCE V STENT IN THE OSTIAL, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THE VISION STENT WAS THEN DEPLOYED AT THIS LOCATION. IT IS LIKELY THE BALLOON INTERACTED WITH THE NEWLY DEPLOYED VISION AND XIENCE STENTS, CONTRIBUTING TO THE REPORTED RESISTANCE DURING RETRACTION. IT WAS REPORTED THE SHAFT WAS PULLED ON AS RESISTANCE WAS ENCOUNTERED, WHICH LIKELY CONTRIBUTED TO THE SHAFT SEPARATING. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING LESION ACCESS OR DELIVERY SYSTEM REMOVAL, THE ENTIRE GUIDING CATHETER AND STENT SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE STENT DELIVERY SYSTEM (SDS) CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND DELIVERY SYSTEM COMPONENTS. ADDITIONAL TREATMENT WAS USED TO EMBED THE SEPARATED SHAFT INTO THE VESSEL WALL WITH A STENT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE STENT IS CHECKED FOR PROPER STRUT DIMENSIONS, AND THE SDS IS INSPECTED AT MULTIPLE STEPS IN THE PROCESS FOR DAMAGE DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION AT THE MEDIAN LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT WAS 70-90% STENOSED, AND A LESION AT THE PROXIMAL PART OF THE 1ST DIAGONAL ARTERY THAT WAS 50-70% STENOSED. PRE-DILATATION WAS PERFORMED PRIOR TO STENTING IN THE 1ST DIAGONAL WITH A 2.5 X 18 MM XIENCE V STENT. THE PROXIMAL PART OF THE DEPLOYED STENT WAS AT THE OSTIAL LEVEL. DILATATION WAS THEN PERFORMED AT THE MEDIAN LAD LESION (WHICH WAS JUST AT THE SEPTAL BRANCH LEVEL) WITH A NON-ABBOTT BALLOON WITH NO DIFFICULTIES NOTED; HOWEVER, DURING ADVANCEMENT OF THE 2.5 X 15 MM VISION STENT, THE DEVICE CAUGHT ON THE PREVIOUSLY PLACED XIENCE V STENT. THE DECISION WAS MADE TO DEPLOY THE VISION STENT AT THIS LOCATION; HOWEVER, AFTER DEPLOYMENT, RESISTANCE WAS FELT DURING REMOVAL OF THE BALLOON. THE DELIVERY SYSTEM WAS PULLED ON, WHICH RESULTED IN A SHAFT SEPARATION. THE DISTAL PART OF THE SHAFT WITH THE BALLOON REMAINED IN THE PATIENT. A 2.5 X 18 MM VISION STENT WAS PLACED AT THE MEDIAN OF THE LAD. A BALLOON CATHETER WAS PLACED WHERE THE SEPARATED DISTAL SHAFT AND BALLOON WERE LOCATED AND INFLATED TO SECURE THE DISTAL SHAFT AND BALLOON TO THE VESSEL WALL PRIOR TO DEPLOYMENT OF A 2.5 X 18 MM VISION STENT OVER THE SHAFT. THE PATIENT CONDITION IS GOOD AND THE PATIENT HAS BEEN DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0120341

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SHEATH: CORDIS 6FSTENT: XIENCE V 2.5 X 18