BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 5210498 · Received November 9, 2015

    Report

    Report Number
    9616099-2015-00536
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING AN ARTERIAL CANAL DILATION IN AN INFANT WITH A PALMAZ GENESIS STENT DELIVERY SYSTEM (SDS), IT WAS REPORTED THAT THE SDS WAS DELIVERED TO THE DUCTUS ARTERIOSUS FROM THE VEIN SIDE THROUGH THE VENTRICLE AND INFLATED AT NOMINAL PRESSURE. HOWEVER, THE BALLOON OF THE PALMAZ GENESIS REMAINED ATTACHED TO THE STENT AND IT WAS NOT POSSIBLE TO REMOVE THE DELIVERY SYSTEM. MULTIPLE UNSUCCESSFUL TECHNIQUES WERE USED IN AN ATTEMPT TO FREE THE BALLOON FROM THE STENT. ULTIMATELY THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. CONSEQUENTLY THE HUB OF THE BALLOON WAS CUT OFF AND A GUIDING CATHETER WAS DELIVERED TO COVER THE BALLOON ALLOWING THE BALLOON CATHETER WAS TO BE REMOVED FROM THE PATIENT. DURING THIS PROCESS THE POSITION OF THE STENT BECAME OUT OF ALIGNMENT IN THE AORTA AND WAS ATTEMPTED TO BE REMOVED. HOWEVER, VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) OCCURRED, REMOVAL EFFORTS WERE STOPPED AND THE STENT WAS LEFT IN THE BODY. THE PROCEDURE WAS FINISHED AFTER THE BLOOD PRESSURE STABILIZED. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE OR DURING PREP. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE LESION WAS HEAVILY TORTUOUS. ONE NON STERILE CATHETER SDS RX GEN. AMIIA 4.0X18 142CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. AN AXIAL BURST WAS OBSERVED ON THE BALLOON AND THE HUB WAS DETACHED FROM THE DEVICE. THE HUB WAS NOT RECEIVED. NO OTHER ANOMALIES WERE OBSERVED. DEVICE WITHDRAWAL TEST COULD NOT BE PERFORMED BECAUSE OF THE DEVICE DAMAGED CONDITIONS. THE DEVICE WAS SENT AT SEM ANALYSIS TO IDENTIFY THE POSSIBLE CAUSE OF BALLOON LEAKAGE. SEM RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHES NEAR TO THE EDGE OF THE BURST. THE BALLOON INTERNAL SURFACE PRESENTED NO DAMAGED. SEM ANALYSIS WAS ALSO PERFORMED TO IDENTIFY THE POSSIBLE CAUSE OF THE HUB DETACHMENT. RESULTS SHOWED THAT BODY SURFACE PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDINGS AREAS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS. THE WIRE PRESENTED EVIDENCE OF CUTTING CHARACTERISTICS AND DUCTILE DIMPLES. IT APPEARS THAT THE SEPARATION OCCURRED WHILE THE WIRE WAS CUT AND BEING STRETCHED/PULLED. REVIEW OF LOT 17080595 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE FAILURE REPORTED AS ¿BALLOON BURST¿ REPORTED BY THE CUSTOMER WAS CONFIRMED AS THE PRODUCT WAS RECEIVED. THE FAILURE REPORTED AS ¿BALLOON - WITHDRAWAL DIFFICULTY-SNAGGED/CAUGHT ON STENT (CARDIOVASCULAR)¿ COULD NOT BE CONFIRMED SINCE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED BECAUSE OF THE DAMAGES OBSERVED ON THE DEVICE. THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER MIGHT ALSO BE RELATED TO PROCEDURAL/HANDLING FACTORS. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS OR SEM ANALYSIS SUGGEST THAT THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENTS. HOWEVER, THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS OR DEVICE MANIPULATION MAY HAVE CONTRIBUTED TO THE BURST. IN THIS CASE, IT IS POSSIBLE THAT THE SDS REMOVAL DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO THE BALLOON BURST, PROCEDURAL FACTORS, VESSEL CHARACTERISTICS AND/OR USER HANDLING. THIS DEVICE IS NOT INDICATED FOR USE IN INFANTS; USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN ARTERIAL CANAL DILATION OF AN INFANT AND THE USE OF A PALMAZ GENESIS STENT DELIVERY SYSTEM (SDS), IT WAS REPORTED THAT THE PALMAZ GENESIS WAS DELIVERED TO THE DUCTUS ARTERIOSIS AND INFLATED AT NOMINAL PRESSURE BY APPROACH FROM THE VEIN SIDE THROUGH THE VENTRICLE. THE STENT WAS EXPANDED AND WAS PLACED. AFTER THAT, THE BALLOON OF THE PALMAZ GENESIS ATTACHED TO THE STENT AND REMOVING THE BALLOON CATHETER WAS NOT POSSIBLE WHEN DECOMPRESSED THE BALLOON AND PULL IT UP. PRESSURIZATION WAS PLIED MORE THAN NOMINAL PRESSURE AND DECOMPRESSION WAS APPLIED TO THE BALLOON. THE CATHETER WAS TURNED AROUND BUT THE BALLOON WAS STILL ATTACHED TO THE STENT. IN THE END, THE BALLOON RUPTURED AT AN UNKNOWN ATMOSPHERE PRESSURE. FINALLY THE HUB OF THE BALLOON WAS CUT AND A GUIDING CATHETER WAS DELIVERED TO COVER THE BALLOON. THE BALLOON CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT. DURING HANDLING, THE POSITION OF THE STENT WAS OUT OF ALIGNMENT WIDELY TO THE AORTA SO THE STENT WAS ATTEMPTED TO BE REMOVED FROM THE AORTA SIDE. HOWEVER VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) OCCURRED DURING THE HANDLING, IT COULD NOT BE REMOVED AND REMAINED IN THE BODY. THE PROCEDURE WAS FINISHED AFTER BLOOD PRESSURE WAS STABLE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. NO ANOMALIES WERE NOTED DURING PREP. INITIALLY, AN APPROACH WAS MADE FROM COMMON FEMORAL ARTERY AND FEMORAL VEIN. IT IS UNKNOWN IF THE BALLOON INFLATED NORMALLY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THE LESION WAS NOT CALCIFIED AND HEAVILY TORTUOUS. IT IS UNKNOWN IF THE PROCEDURAL CD ARE AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741938 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA 17080595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention