BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 2010055 · Received March 8, 2011

    Report

    Report Number
    9610978-2011-00047
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE THE SDS BALLOON HAD LEAKAGE DURING POSITIVE PRESSURE AND THE STENT DISLODGED. THE INFORMATION RECEIVED INDICATED THAT THE STENT WOULD NOT DEPLOY, WHEN PLACED IN RIGHT POSITION. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC AND WAS 2.5-3CM LONG, TORTUOUS AND STENOSED. WHEN THE BALLOON WAS INFLATED CONTRAST LEAKED OUT OF THE BALLOON (I.E. THE BALLOON WAS PERFORATED BEFORE USE) AND THE BALLOON DID NOT INFLATE AT ALL. THEN THE STENT COULD NOT BE RETRIEVED, AS IT WOULD NOT STAY ON THE BALLOON. ALTHOUGH THE STENT MOVED AND WAS NOT IN RIGHT POSITION, IT REMAINED IN THE ILIAC AND THE CONSULTANT WAS ABLE TO INSERT A NEW BALLOON THROUGH AND DEPLOY THE STENT SAFELY. THE STENT DISLODGED AS THE ORIGINAL BALLOON WAS REMOVED BUT DID NOT STAY IN ACROSS LESION (PARTLY IN LESION PARTLY OUT), SO THE PHYSICIAN PASSED A NEW BALLOON THROUGH IT TO CAPTURE IT AND PULLED IT BACK TOWARDS THE FEMORAL LOWER THAN THE TREATMENT SITE AND DEPLOYED IT. THE STENT WAS NOT DEPLOYED IN THE TARGET LESION. THE LESION WAS LEFT FREE TO STENT ACROSS OF IT. THE STENTING PROCEDURE ACROSS THE ILIAC LESION WAS CONTINUED WITH A SMART STENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL. THE BALLOON USED TO DEPLOY THE STENT WAS AN OPTA PRO BALLOON. THERE WERE NO ISSUES EXPERIENCED DURING STENT DEPLOYMENT WITH THE 2ND BALLOON. THE DEVICE WAS PREPPED IN A NORMAL MANNER (FLUSHED, ETC.). THERE WAS NO DAMAGE NOTICED AT THIS POINT. THE STENT WAS ADVANCED TO THE LESION WITH NO PROBLEMS. THE PRODUCT WILL BE RETURNED FOR EVALUATION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NO STERILE CATHETER SDS GENESIS OPTA PRO 9.0X39MM/80CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THERE WERE BLOOD RESIDUES ON THE CATHETER. THE BALLOON WAS INFLATED AND DEFLATED. THE STENT WAS NOT INCLUDED IN THE RETURNED DEVICE; HOWEVER STENT'S MARKS WERE OBSERVED IN THE BALLOON AND WERE NOTED BETWEEN THE MARKER BANDS. NO OTHER ANOMALY WAS OBSERVED IN THE RETURNED DEVICE. AN ATTEMPT TO INFLATE THE BALLOON WAS DONE; A LEAK WAS NOTED AT 1.70 CM FROM THE DISTAL TIP. PROCEDURE WAS PERFORMED ACCORDING TO DP 12169733 REV. 1. A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF BALLOON LEAKAGE. RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASIONS NEAR THE LEAK-HOLE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE BALLOON LEAK COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BAND EXHIBITED NO ANOMALIES. 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. FAILURES REPORTED BY THE CUSTOMER FOR BALLOON LEAKAGE DURING POSITIVE PRESSURE AND STENT DISLODGED IN PATIENT WERE CONFIRMED; HOWEVER THE EXACT CAUSE OF THE BALLOON PIN HOLE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. FOR THE STENT DISLODGED FAILURE THE BALLOON PRESENTS STENT'S MARK, THE STENT WAS NOT INCLUDED WITH THE RETURNED DEVICE CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS AND STENTS FROM LEAVING THE FACILITY. (B)(4). NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. THE FAILURES REPORTED BY THE CUSTOMER FOR BALLOON LEAKAGE DURING POSITIVE PRESSURE AND STENT DISLODGED IN PATIENT WERE CONFIRMED; HOWEVER THE EXACT CAUSE OF THE BALLOON PIN HOLE FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENTS.

    Additional Manufacturer Narrative · 1

    THERE WERE NO ISSUES EXPERIENCED DURING STENT DEPLOYMENT WITH THE 2ND BALLOON. THE DEVICE WAS PREPPED IN A NORMAL MANNER (FLUSHED, ETC.). THERE WAS NO DAMAGE NOTICED AT THIS POINT. THE STENT WAS ADVANCED TO THE LESION WITH NO PROBLEMS. THE PRODUCT WILL BE RETURNED FOR EVALUATION. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT THE PRODUCT INTO THE PATIENT. THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DEVICE OR CROSSING THE LESION. THE CATHETER WAS NEVER IN AN ACUTE BEND. THE PALMAZ GENESIS SDS DEVICE IN THIS REPORT IS NOT DISTRIBUTED IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE PALMAZ GENESIS SDS DISTRIBUTED IN THE US. THE PRODUCT HAS BEEN RETURNED FOR ANALYSIS, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE STENT WOULD NOT DEPLOY, WHEN PLACED IN RIGHT POSITION. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC AND WAS 2.5-3CM LONG, TORTUOUS AND STENOSED. WHEN THE BALLOON WAS INFLATED CONTRAST LEAKED OUT OF THE BALLOON (I.E. THE BALLOON WAS PERFORATED BEFORE USE) AND THE BALLOON DID NOT INFLATE AT ALL. THEN THE STENT COULD NOT BE RETRIEVED, AS IT WOULD NOT STAY ON THE BALLOON. ALTHOUGH THE STENT MOVED AND WAS NOT IN RIGHT POSITION, IT REMAINED IN THE ILIAC AND THE CONSULTANT WAS ABLE TO INSERT A NEW BALLOON THROUGH AND DEPLOY THE STENT SAFELY. THE STENT DISLODGED AS THE ORIGINAL BALLOON WAS REMOVED BUT DID NOT STAY IN ACROSS LESION (PARTLY IN LESION PARTLY OUT), SO THE PHYSICIAN PASSED THROUGH A NEW BALLOON TO CAPTURE IT AND PULLED IT BACK TOWARDS THE FEMORAL LOWER THAN THE TREATMENT SITE AND DEPLOYED IT. THE STENT WAS NOT DEPLOYED IN THE TARGET LESION. THE LESION WAS LEFT FREE TO STENT ACROSS OF IT. THE STENTING PROCEDURE ACROSS THE ILIAC LESION WAS CONTINUED WITH A SMART STENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE DURING WITHDRAWAL. THE BALLOON USED TO DEPLOY THE STENT WAS AN OPTA PRO BALLOON. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 15218207

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S 6F BRITE TIP GUIDE CATHETER