BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 3072496 · Received April 23, 2013

    Report

    Report Number
    9616099-2013-00244
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER STENTING OF A HEAVILY CALCIFIED, MILDLY TORTUOUS AND 90% STENOSED RIGHT RENAL ARTERY, THE PHYSICIAN REMOVED THE PALMAZ GENESIS DELIVERY SYSTEM AND NOTED A SEPARATION APPROXIMATELY 3 MM FROM THE DISTAL END. INITIALLY, DIRECT-STENTING TO THE LESION WAS ATTEMPTED. THERE WAS NO RESISTANCE WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE AND NO EXCESSIVE TORQUING REQUIRED. WITH SEVERAL TRIALS, THE LESION WAS CROSSED AND GENESIS STENT WAS DILATED AT THE LESION. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, THE PHYSICIAN EXPERIENCED RESISTANCE, REPORTEDLY DUE TO THE DISTAL TIP BECOMING CAUGHT ON THE CALCIFICATION IN THE LESION. IT WAS THEN NOTED THAT THE DISTAL TIP WAS SEPARATED AND REMAINED ON THE GUIDEWIRE. THE PHYSICIAN CAREFULLY REMOVED THE GUIDEWIRE WITH THE DISTAL TIP AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN COMMENTED THAT NO PART OF THE PRODUCT REMAINED IN THE PATIENT. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE DEVICE WAS STORED, PREPPED AND INSPECTED PER IFU INSTRUCTIONS. THERE WERE NO ANOMALIES NOTED DURING PREPPING. THERE WAS NO REPORT OF PATIENT INJURY. ONE NON STERILE CATHETER CORDIS AMIIA 5.0 MM X 20.0 MM 142.0 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEARED TO HAVE BEEN INFLATED. THERE WERE INFLATION MEDIUM RESIDUES OBSERVED IN THE RETURNED DEVICE. DISTAL TIP WAS RIPPED AT 3.0 MM FROM DISTAL TIP SINCE DISTAL TIP SHOWED ELONGATION. 3.0 MM OF DISTAL TIP WAS RECEIVED ON AN UNKNOWN GW. INSERTION WITHDRAWAL TEST WAS PERFORMED WITH THE UNKNOWN GW .014 RETURNED AND WAS INTRODUCED WITHOUT DIFFICULTY AT THE LUMEN OF THE DISTAL TIP. INSERTION WITHDRAWAL TEST PERFORMED WITH THE LAB SAMPLE GW .014 WAS INTRODUCED WITHOUT DIFFICULTY AT THE LUMEN OF THE DISTAL TIP ACCORDING. DIMENSIONAL ANALYSIS FOR OD PROXIMAL SEAL COULD BE PERFORMED USING CSI 5F AND NO RESISTANCE FRICTION WAS NOTED. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF DISTAL TIP FRACTURE. SEM RESULTS SHOW THAT THE TIP 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. 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 SEPARATION OF THE DEVICE WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. BASED ON THE INFORMATION AVAILABLE, THERE ARE VESSEL CHARACTERISTICS (HEAVY CALCIFICATION) AND PROCEDURAL FACTORS (THE DISTAL TIP OF THE DEVICE BECAME CAUGHT ON THE CALCIFICATION DURING WITHDRAWAL FROM THE VESSEL) THAT MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. IN ORDER THE REMOVE THE DEVICE, THE OPERATOR MAY HAVE USED EXCESSIVE FORCE AS EVIDENCED BY ELONGATION AT THE POINT OF SEPARATION NOTED IN THE ANALYSIS. NEITHER THE DHR, ANALYSIS NOR THE EVENT DESCRIPTION SUGGESTS THAT THE SEPARATION OR WITHDRAWAL DIFFICULTY FROM THE VESSEL COULD HAVE BEEN DUE TO THE MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, AFTER THE PHYSICIAN REMOVED THE PALMAZ GENESIS DELIVERY SYSTEM, HE NOTICED A SEPARATION APPROXIMATELY 3MM FROM THE DISTAL END. THE DISTAL PART OF THE TIP WAS ON THE GUIDEWIRE (CRUISE, SJM). THE PHYSICIAN CAREFULLY REMOVED THE GUIDEWIRE WITH THE DISTAL TIP AND THE PROCEDURE FINISHED WITHOUT PATIENT INJURY. INITIALLY, THE PHYSICIAN TRIED DIRECT-STENTING TO THE CALCIFIED LESION IN THE RIGHT RENAL ARTERY. THERE WAS NO RESISTANCE WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THERE WAS NO EXCESSIVE TORQUING REQUIRED. WITH SEVERAL TRIALS, THE LESION WAS CROSSED AND GENESIS STENT WAS DILATED AT THE LESION. THEN, WHEN THE PHYSICIAN REMOVED THE DELIVERY SYSTEM WITH RESISTANCE, HE NOTICED THAT THE DISTAL TIP WAS SEPARATED. RESISTANCE WAS FELT DUE TO INTERFERENCE BETWEEN THE DISTAL TIP AND THE CALCIFICATION IN THE LESION. THE PALMAZ GENESIS DELIVERY SYSTEM WAS CAUGHT ON THE LESION. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE PHYSICIAN COMMENTED THAT NO PART OF THE PRODUCT REMAINED IN THE PATIENT. THE TARGET LESION WAS DESCRIBED AS HEAVILY CALCIFIED, MILD TORTUOSITY AND 90% STENOSED. THE DEVICE WAS STORED, PREPPED AND INSPECTED PER IFU INSTRUCTIONS. THERE WERE NO ANOMALIES NOTED DURING PREPPING. THE PRODUCT WILL BE RETURNED TO YOUR SIDE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175407 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15628189

    Patients

    Seq Age Sex Outcome Treatment
    1