BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK 8

    MDR report key: 2031866 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02062
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE BALLOON AND CONTRAST VISIBLE ON THE BALLOON, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED, CONFIRMING THE REPORTED EVENT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WAS BALLOON SHREDDING ON THE DISTAL TAPER AND PEELING AT THE DISTAL END OF THE BALLOON. THERE WAS A KINK IN THE DISTAL SHAFT 6.8 CM PROXIMAL TO THE PROXIMAL SEAL. THERE MULTIPLE BENDS IN THE HYPOTUBE 5 CM DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 55 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK AND BENDS MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. RETURN OF THE DISLODGED STENT MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IN THIS CASE, IT IS POSSIBLE THE PROTECTIVE SHEATH WAS INADVERTENTLY HANDLED DURING REMOVAL, RESULTING IN THE STENT DISLODGING AND THE NOTED BALLOON SHREDDING. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MANUFACTURING PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING HANDLING OF THE STENT AS THERE WAS NO DAMAGE OR PEELING NOTED TO THE BALLOON IN THE CASE INFORMATION. TO HELP ENSURE THAT THE BALLOON SHREDDING IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL SDS ARE VISUALLY INSPECTED FOR BALLOON SHREDDING. A CONCLUSIVE CAUSE FOR THE STENT DISLODGEMENT COULD NOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD ON THE BALLOON AND CONTRAST VISIBLE ON THE BALLOON, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED, CONFIRMING THE REPORTED EVENT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WAS BALLOON SHREDDING ON THE DISTAL TAPER AND PEELING AT THE DISTAL END OF THE BALLOON. THERE WAS A KINK IN THE DISTAL SHAFT 6.8 CM PROXIMAL TO THE PROXIMAL SEAL. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE 5 CM DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 55 CM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK AND BENDS MAY HAVE OCCURRED DURING PACKAGING, HANDLING, AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS MEASURED AND MET MANUFACTURING CRITERIA. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. RETURN OF THE DISLODGED STENT MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IN THIS CASE, IT IS POSSIBLE THAT THE STENT DISLODGEMENT AND THE NOTED BALLOON SHREDDING OCCURRED WHEN THE PROTECTIVE SHEATH WAS REMOVED. A CONCLUSIVE CAUSE FOR THE STENT DISLODGEMENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE RX MULTI-LINK 8 STENT SYSTEM, AFTER REMOVAL OF THE PROTECTIVE SHEATH, IT WAS NOTED THAT THE STENT HAD DISLODGED FROM THE BALLOON. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. A NEW MULTI-LINK 8 STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK 8 CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0022441

    Patients

    Seq Age Sex Outcome Treatment
    1