BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 2072180 · Received April 28, 2011

    Report

    Report Number
    9616099-2011-00286
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TRANSEND GUIDEWIRES, ORBIT COIL AND AMIIA STENT. THE TARGET LESION FOR THE STENT PLACEMENT WAS OSTIAL OF LEFT VERTEBRAL ARTERY WITH NO CALCIFICATION OR VESSEL TORTUOSITY, AND THE RATE OF STENOSIS WAS 0%. PRIOR TO INSERTING THE GUIDEWIRE, THE GUIDEWIRE LUMEN WAS FLUSH WITH HEPARINIZED SALINE, AND AFTER RESISTANCE WAS EXPERIENCED, THE GW WAS REMOVED FROM THE PALMAZ GENESIS. WHEN THE GW WAS WIPED OFF, A PIECE OF FRAGMENT WAS FOUND. OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON THE DEVICE. ADDITIONAL INFORMATION IS EXPECTED. 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 15206977 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15206977. CATH ASSY AMIIA SUBASSEMBLY LOT 15205645 WAS REVIEWED AND (B)(4). IT WAS OBSERVED DURING REVIEW THAT NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO OTHER INCIDENTS WERE NOTED THAT COULD BE POTENTIALLY RELATED TO THE COMPLAINT REPORTED. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 616099-2011-00286 AND 1058196-2011-00184. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING TREATMENT FOR BASILAR ARTERY ANEURYSM, THE ORBIT COIL (DETAILS UNK) WAS UNRAVELED IN THE PATIENT. TO ATTACH THE COIL AGAINST THE VESSEL, PALMAZ GENESIS (SDS RX GEN. AMIIA 5.0X15 142CM (COMPLAINT PRODUCT) WAS USED FOR AN EMERGENCY USE, HOWEVER DURING DELIVERY, LARGE (F/R) FRICTION/RESISTANCE OCCURRED WITH 0.014 TRANSEND EX GUIDEWIRE (GW) PRIOR TO INSERTING IN THE PATIENT. ALTHOUGH THE LARGE F/R WAS STILL EXPERIENCED, THE DEVICE WAS REMOVED FROM THE GW. WHEN THE GW WAS ALSO REMOVED, A PIECE OF FRAGMENT WAS FOUND. THE DISTAL TIP OF THE DEVICE WAS INSPECTED BUT NO DAMAGE WAS FOUND, AND THE PHYSICIAN THOUGHT IT WAS A PART OF THE GW. THE GW WAS CHANGED TO ASAHI CHIKAI GW (ASAHI INTECC). THE DEVICE WAS DELIVERED ONCE AGAIN AND THE STENT WAS PLACED IN THE TARGET LESION. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. AFTER THE PROCEDURE, WHEN THE TRANSEND EX GW AND THE PALMAZ GENESIS WERE INSPECTED ONCE AGAIN, IT SEEMED TO BE THE FRAGMENT COULD BE THE DISTAL TIP OF THE PG DEVICE. THE COMPLAINT PRODUCT WILL BE RETURNED TO YOUR SIDE FOR ANALYSIS TOGETHER WITH THE ASAHI CHIKAI GW. THE TRANSEND EX GW WILL NOT BE RETURNED AS IT WAS ALREADY DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA 15206977

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male