BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1201460 · Received October 16, 2008

    Report

    Report Number
    2024168-2008-00967
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE DISTAL SHAFT SEPARATION. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE SDS WAS RETURNED WITH BLOOD VISIBLE IN THE GUIDE WIRE LUMEN INFLATION LUMEN AND IN THE BALLOON. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE SHAFT WAS SEPARATED 6.2 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE SEPARATED EDGES WERE STRETCHED AND JAGGED. THERE WERE MULTIPLE BENDS IN THE PROXIMAL SHAFT HYPOTUBE. DELTRONIC PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER AT THE SEPARATED SHAFT INNER MEMBER. THE INNER DIAMETER MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND RESULTS OF THE RETURNED DEVICE ANALYSIS PRESENCE OF CONTRAST IN THE INFLATION LUMEN AND BALLOON, WITH THE BALLOON LOOSELY FOLDED IS CONSISTENT WITH THE REPORTED DEPLOYMENT OF THE STENT IMPLANT. ANALYSIS OF THE RETURNED DEVICE DID FIND THE SHAFT SEPARATED DISTAL TO THE GUIDE WIRE EXIT NOTCH WITH BLOOD IN THE INFLATION LUMEN AND GUIDE WIRE LUMEN. THE FRACTURE FACES WERE STRETCHED AND JAGGED, SUGGESTING THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD. ALTHOUGH, THERE WAS NO RESISTANCE REPORTED AS BEING ENCOUNTERED DURING RETRACTION OF THE SDS, THIS TYPE OF MECHANICAL DAMAGE MAY OCCUR IF AN ATTEMPT IS MADE TO PULL THE SDS AGAINST RESISTANCE. IT IS POSSIBLE THAT THERE MAY HAVE BEEN INTERACTION OF THE SDS WITH OTHER DEVICES DURING THE REMOVAL OF THE SDS AND EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO OVERCOME THE INTERACTION. ALSO KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE SDS MATERIALS SUCH THAT SUBSEQUENT HANDLING CAN CAUSE SEPARATION. THERE WERE NOTED MULTIPLE BENDS IN THE PROXIMAL SHAFT. SINCE THESE WERE NOT REPORTED IN THE INCIDENT DETAIL, IT IS POSSIBLE THAT THESE OCCURRED DURING HANDLING OF THE DEVICE DURING THE PROCEDURE. IT IS ALSO POSSIBLE THAT THIS OCCURRED DURING HANDLING OF THE DEVICE FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR EVALUATION. ANOTHER POSSIBLE EXPLANATION FOR THE SHAFT SEPARATION MAY HAVE BEEN DUE TO MATERIAL PROPERTIES THAT MAY HAVE CAUSED A FRACTURE IN THE SHAFT. THERE IS NO INDICATION TO SUGGEST THAT THIS WAS THE ISSUE. THE INNER DIAMETER AT THE SEPARATED SHAFT INNER MEMBER OF THE RETURNED SDS MET MANUFACTURING CRITERIA. AS MENTIONED IN THE INCIDENT DESCRIPTION, THE DETACHED SHAFT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT EFFECT OF REMOVAL OF FOREIGN BODY, ALTHOUGH NOT SPECIFICALLY ASSOCIATED WITH SHAFT DETACHMENT IN THE RAM, IS A RECOGNIZED POTENTIAL PATIENT EFFECT THAT IS ASSOCIATED WITH INABILITY TO REMOVE SYSTEM PRE OR POST DEPLOYMENT. A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE SHAFT SEPARATION. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: SHAFT SEPARATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: SEPARATION OF DISTAL END OF SHAFT. IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT OF THE VISION STENT DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) FROM THE PATIENT, THE DISTAL SHAFT SEPARATED AND REMAINED IN THE PATIENT. A DILATATION BALLOON WAS USED TO RETRIEVE THE SEPARATED SHAFT FROM THE PATIENT. THERE WAS NO MENTION OF ANY RESISTANCE DURING REMOVAL OF THE SDS FROM THE PATIENT. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 7021931

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention