BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1883827 · Received October 27, 2010

    Report

    Report Number
    9610978-2010-00214
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    September 28, 2010
    Report Date
    October 9, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: SHEATH: 7F, CORDIS, PRODUCT CODE: 401745M, LOT NO: 14128724. GUIDEWIRE: .035, CORDIS, PRODUCT CODE: 502442E, LOT: F0310743. INDEFLATOR: CORDIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS AVAILABLE FOR TESTING AND EVALUATION BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT BASED ON THE ANALYSIS OF THE RETURNED DEVICE, WHICH NOTED AN ADDITIONAL EVENT, BALLOON BURST, UPDATED TO REFLECT THIS NEW INFORMATION. DURING DIRECT STENTING OF A SEVERELY CALCIFIED 90% OCCLUDED LEFT COMMON ILIAC ARTERY IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE AND THE STENT COULD NOT BE DEPLOYED. THERE WAS A LITTLE RESISTANCE/FRICTION WHILE INSERTING THE STENT DELIVERY SYSTEM (SDS) THROUGH THE GUIDE CATHETER AND THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND ACROSS THE LESION. FORCE WAS APPLIED TO THE SDS TO FACILITATE CROSSING OF THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE UNIT SDS GENESIS 10 MM X 79 MM AND 80 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. NO DRY BLOOD RESIDUES WERE NOTED IN UNIT. THE BALLOON APPEARS AS IF IT HAS NOT BEEN INFLATED AND DEFLATED, NO DAMAGES WERE NOTED ON THE BALLOON. AN INSERTION TEST WAS PERFORMED USING THE RECOMMENDED 7F CSI AND 9F GUIDE CATHETER BY PD0041 REV. 8 AND NO RESISTANCE OR FRICTION WAS FELT. STENT CROSSING PROFILE WAS MEASURED AND ALL VALUES WERE WITHIN SPECIFICATION OF<= 2.46 MM, REFERENCE DF 11892349 REV. 6. RESULTS WERE AS FOLLOW: PROXIMAL SIDE 2.25, MIDDLE 2.28 AND DISTAL 2.26 MM. A SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT, RESULTS SHOW THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASIONS AND SPLITS NEAR THE TEAR EDGE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER SURFACE ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE MARKER BAND EXHIBITED EVIDENCE OF TWO MARKS/SCRATCHES. IT IS POSSIBLE THAT THE CAUSE OF THE BALLOON DAMAGE COULD BE RELATED TO THE CAUSE OF THE MARKER BAND DAMAGE; HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. 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. THE REPORTED CUSTOMER COMPLAINTS FOR BALLOON DAMAGED AND INFLATION DIFFICULTY-UNABLE TO INFLATE WERE CONFIRMED, HOWEVER COMPLAINT FOR RESISTANCE/FRICTION OUTER BODY WAS NOT CONFIRMED; THE EXACT CAUSE OF THE CONFIRMED FAILURES COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURES EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. REFER TO MANUFACTURING WORK INSTRUCTIONS (B)(4). NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE BY CUSTOMER COMPLAINT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS ALONG WITH PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    PTA WAS BEING PERFORMED ON A 90% OCCLUDED LESION IN THE LEFT COMMON ILIAC ARTERY OF 7CM IN LENGTH IN AN 8.6MM VESSEL DIAMETER. THE LESION WAS SEVERELY CALCIFIED. A 7F SHEATH WAS USED AND THE LESION WAS NOT PRE-DILATED. A 10X79MM PALMAZ GENESIS STENT ON AN OPTA PRO BALLOON CATHETER WAS BEING DEPLOYED BUT WHEN THE STENT REACHED THE LESION, THE PHYSICIAN FELT FRICTION, AND THEN THE BALLOON COULD NOT BE INFLATED. AS A RESULT, THE STENT COULD NOT BE DEPLOYED. IT WAS SUSPECTED WHEN THE STENT CROSSED THE CALCIFIED LESION BY FORCE, THE BALLOON SUFFERED FRICTION AND CAUSED SOME DAMAGE. THE PHYSICIAN THEN CHANGED TO USE SMART STENT 10X80MM TO COMPLETE THE PROCEDURE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT AND THE DEVICE PREPPED NORMALLY. THE BRAND OF CONTRAST USED IS NOT KNOWN BUT THE RATIO WAS 1:1. THERE WAS LITTLE RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER. THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND DIFFICULTY CROSSING THE LESION. THE TYPE OF BALLOON DAMAGE IS NOT KNOWN BECAUSE IT CANNOT CLEARLY BE OBSERVED BY THE EYE. THERE WERE NO NEGATIVE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT AND THE DEVICE WAS EASILY REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R1008547

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR