BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3012501 · Received March 20, 2013

    Report

    Report Number
    1058196-2013-00074
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE CORRECT DATE FOR MEDWATCH REPORT FOLLOW-UP IS (B)(4) 2013. NO FURHTER INFORMATION WILL BE FORTHCOMING,

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT TWO DAYS POST PROCEDURE COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (B)(4) OF THE RICA PCOM SEGMENT, THE PATIENT HAD SEIZURE AND LEFT SIDED WEAKNESS, THE MRI SHOWED SMALL SCATTERED AREAS OF ACUTE SMALL ISCHEMIA IN THE RIGHT HEMISPHERE, AND THE CTA SHOWED VESSELS PROXIMAL AND DISTAL TO STENT WIDELY PATEN, INTRA-STENT OBSCURED BY METAL ARTIFACT. THE PATIENT WAS TO CONTINUE ON ASPIRIN AND PLAVIX WITH NO CHANGE IN THE TREATMENT PLAN. THE PATIENT WAS DISCHARGED TO SKILLED NURSING FACILITY FOR SUPPORTIVE CARE AND REHAB SEVEN DAYS AFTER THE PROCEDURE. THE PATIENT IS PRESENTLY NEUROLOGICALLY STABLE, MILD LEFT ARM WEAKNESS. VESSEL TORTUOUSITY WAS MEDIUM. TARGET LESION CHARACTERISTICS WERE 5MM BROAD DYSPLASTIC NECK GIVING RISE TO TINY RIGHT PCOM ARTERY. CONCOMITANT MEDICATIONS ARE ASPIRIN, PLAVIX, AND HEPARIN. THE PROCEDURE COMPLETED WITHOUT COMPLICATION EXCEPT FOR SMALL RETROPERITONEAL HEMATOMA., THE DEVICES ARE IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. PRIOR TO THE PROCEDURE, THE PATIENT DID NOT HAVE ANY NEUROLOGICAL DEFICITS, BUT DID HAVE LIMITATIONS WITH LLE DUE TO FRACTURE IN FOUR MONTH PRIOR TO THE PROCEDURE. THE PATIENT HAD KNOWN SEIZURE DISORDER. THE COILS REMAINED WITHIN THE ANEURYSM. THE VESSEL DIAMETER WAS NOT KNOW, BUT IT WAS REPORTED THAT THE STENT WAS OPENED AND WITHOUT ANY PROBLEMS. THE ACT INTRA PROCEDURE WAS 250-290, PT/INR/PTT WNL PRE-PROCEDURE. PLAVIX PRU 88, ASPIRIN ARU 466 PRE-PROCEDURE. THE MEDICATION GIVEN DURING THE PROCEDURE CONSISTED OF HEPARIN TO MAINTAIN ACT, AND RECEIVED ADDITIONAL IV DOSE OF KEPPRA FOR SEIZURE PREVENTION PRE-PROCEDURE. OTHER DEVICES USED CONSISTED OF ORBIT GALAXY COILS (640CX0202/ 15753167 X2 AND (B)(4)). THE PATIENT HAS MADE GOOD RECOVERY AND FEELS BACK TO WHAT IS THE PATIENT'S KNOWN NORMAL, AND IS AT HOME FROM REHAB. PER (B)(4) REPORT (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10106131. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. CEREBRAL ISCHEMIA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. THE RELATIONSHIP TO THE ENTERPRISE VRD CANNOT BE CONCLUSIVELY DETERMINED. ALTHOUGH BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS POST PROCEDURE COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD ((B)(4)) OF THE RICA PCOM SEGMENT, THE PATIENT HAD SEIZURE AND LEFT SIDED WEAKNESS, THE MRI SHOWED SMALL SCATTERED AREAS OF ACUTE SMALL ISCHEMIA IN THE RIGHT HEMISPHERE, AND THE CTA SHOWED VESSELS PROXIMAL AND DISTAL TO STENT WIDELY PATEN, INTRA-STENT OBSCURED BY METAL ARTIFACT. THE PATIENT WAS TO CONTINUE ON ASPIRIN AND PLAVIX WITH NO CHANGE IN THE TREATMENT PLAN. THE PATIENT WAS DISCHARGED TO SKILLED NURSING FACILITY FOR SUPPORTIVE CARE AND REHAB SEVEN DAYS AFTER THE PROCEDURE. THE PATIENT IS PRESENTLY NEUROLOGICALLY STABLE, MILD LEFT ARM WEAKNESS. VESSEL TORTUOUSITY WAS MEDIUM. TARGET LESION CHARACTERISTICS WERE 5MM BROAD DYSPLASTIC NECK GIVING RISE TO TINY RIGHT PCOM ARTERY. CONCOMITANT MEDICATIONS ARE ASPIRIN, PLAVIX, AND HEPARIN. THE PROCEDURE COMPLETED WITHOUT COMPLICATION EXCEPT FOR SMALL RETROPERITONEAL HEMATOMA., THE DEVICES ARE IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. PRIOR TO THE PROCEDURE, THE PATIENT DID NOT HAVE ANY NEUROLOGICAL DEFICITS, BUT DID HAVE LIMITATIONS WITH LLE DUE TO FRACTURE IN FOUR MONTH PRIOR TO THE PROCEDURE. THE PATIENT HAD KNOWN SEIZURE DISORDER. THE COILS REMAINED WITHIN THE ANEURYSM. THE VESSEL DIAMETER WAS NOT KNOW, BUT IT WAS REPORTED THAT THE STENT WAS OPENED AND WITHOUT ANY PROBLEMS. THE ACT INTRA PROCEDURE WAS 250-290, PT/INR/PTT WNL PRE-PROCEDURE. PLAVIX PRU 88, ASPIRIN ARU 466 PRE-PROCEDURE. THE MEDICATION GIVEN DURING THE PROCEDURE CONSISTED OF HEPARIN TO MAINTAIN ACT, AND RECEIVED ADDITIONAL IV DOSE OF KEPPRA FOR SEIZURE PREVENTION PRE-PROCEDURE. OTHER DEVICES USED CONSISTED OF ORBIT GALAXY COILS ((B)(4)). THE PATIENT HAS MADE GOOD RECOVERY AND FEELS BACK TO WHAT IS THE PATIENT'S KNOWN NORMAL, AND IS AT HOME FROM REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116403 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10106131

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening ORBIT COILS