BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHRO 2/14 200 CM STANDARD PRESHAPED

    MDR report key: 2827963 · Received November 12, 2012

    Report

    Report Number
    3008853977-2012-00002
    Event Type
    Death
    Date Received
    November 12, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 2, 2012
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. THERE IS NO INDICATION FROM THE INFORMATION AVAILABLE THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATION NONCONFORMANCE. THERE IS ALSO NO INDICATION THAT THE SYNCHRO DEVICE MALFUNCTIONED. THE REPORTED HEMORRHAGE, VESSEL PERFORATION AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS ASSOCIATED TO THESE TYPES OF PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DFU. THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF A RECURRENT BASILAR TIP ANEURYSM. NO TECHNICAL ISSUES WERE REPORTED DURING THE PROCEDURE. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, A SUBARACHNOID HEMORRHAGE WAS IDENTIFIED ORIGINATING FROM THE RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). THE PHYSICIAN BELIEVES THAT VESSEL RUPTURE OCCURRED DUE TO A GUIDEWIRE PERFORATION. IT WAS REPORTED THAT THE PATIENT DIED; HOWEVER, THE RELATIONSHIP OF THE VESSEL DISSECTION TO THE PATIENT'S OUTCOME OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF A RECURRENT BASILAR TIP ANEURYSM. NO TECHNICAL ISSUES WERE REPORTED DURING THE PROCEDURE. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, A SUBARACHNOID HEMORRHAGE WAS IDENTIFIED ORIGINATING FROM THE RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). THE PHYSICIAN BELIEVES THAT VESSEL RUPTURE OCCURRED DUE TO A GUIDEWIRE PERFORATION. IT WAS REPORTED THAT THE PATIENT DIED; HOWEVER, THE RELATIONSHIP OF THE VESSEL DISSECTION TO THE PATIENT'S OUTCOME OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF A RECURRENT BASILAR TIP ANEURYSM. NO TECHNICAL ISSUES WERE REPORTED DURING THE PROCEDURE. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, A SUBARACHNOID HEMORRHAGE WAS IDENTIFIED ORIGINATING FROM THE RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). THE PHYSICIAN BELIEVES THAT VESSEL RUPTURE OCCURRED DUE TO A GUIDEWIRE PERFORATION. IT WAS REPORTED THAT THE PATIENT DIED; HOWEVER, THE RELATIONSHIP OF THE VESSEL DISSECTION TO THE PATIENT'S OUTCOME OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2/14 200 CM STANDARD PRESHAPED WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH B25770

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| O NEUROFORM 3 EZ (STRYKER)