BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 2200976 · Received August 11, 2011

    Report

    Report Number
    9616099-2011-00598
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: CRUISE GW (SJM) AND ENCORE INDEFLATOR (BSJ). THE REPORT RECEIVED THAT PTA WAS BEING PERFORMED ON A 99% OCCLUDED LESION FOR IN-STENT RESTENOSIS OF A PALMAZ GENESIS LOCATED IN THE OSTIUM OF THE LEFT RENAL ARTERY. THE LESION WAS HEAVILY CALCIFIED WITH MODERATE VESSEL TORTUOSITY. AN AVIATOR PLUS WAS DELIVERED, HOWEVER THE BALLOON RUPTURED AT APPROXIMATELY 6 ATMOSPHERES DURING INFLATION. THE PHYSICIAN'S COMMENT WAS THAT THE BALLOON POSSIBLY CAUGHT WITH THE STENT EDGE AT THE AORTA SIDE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY AND WAS EASILY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT R0808200 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. WELL DOCUMENTED POTENTIAL COMPLICATION OF STENT PLACEMENT IS SUBSEQUENT INTIMAL HYPERPLASIA AND OCCLUSION. PROGRESSION OF ATHEROSCLEROSIS IS AN EXPECTED OUTCOME OF THE DISEASE PROCESS. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED BALLOON BURST. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURER NUMBERS 9616099-2011-00598 AND 9616099-2011-00600.

    Description of Event or Problem · 1

    THE REPORT RECEIVED THAT PTA WAS BEING PERFORMED ON A 99% OCCLUDED LESION FOR IN-STENT RESTENOSIS OF A PALMAZ GENESIS (CATALOG AND LOT NUMBERS UNKNOWN) THAT WAS IN THE OSTIUM OF THE LEFT RENAL ARTERY. THE LESION WAS HEAVILY CALCIFIED WITH MODERATE VESSEL TORTUOSITY. AFTER THE TARGET LESION WAS CROSSED WITH CRUISE GW (SJM), AN AVIATOR PLUS WAS DELIVERED. HOWEVER THE BALLOON RUPTURED AT APPROXIMATELY 6ATM DURING THE INFLATION WITH AN ENCORE INDEFLATOR (BSJ). THE PROCEDURE WAS COMPLETED USING 424-4520W WITHOUT PATIENT INJURY. NO PRODUCT RETURN. THE PHYSICIAN'S COMMENT: THE BALLOON WAS RUPTURED AS THE BALLOON POSSIBLY CAUGHT WITH THE STENT EDGE AT THE AORTA SIDE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THE DEVICE PREPPED NORMALLY AND WAS EASILY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA R0808200

    Patients

    Seq Age Sex Outcome Treatment
    1