BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 4172797 · Received October 15, 2014

    Report

    Report Number
    3008853977-2014-00332
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    August 1, 2013
    Report Date
    September 29, 2014
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. VESSEL VASOSPASM, HEMORRHAGE, STROKE, HEADACHE AND NEUROLOGICAL DEFICIT ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE THAT THE SUBJECT GUIDEWIRE WAS UNEVENTFULLY DELIVERED IN THE P1 SEGMENT OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) AND ANGIOPLASTY WAS PERFORMED TO TREAT THE BA STENOSIS. HOWEVER, DURING THE RETRIEVAL OF THE DEVICE, THE GUIDEWIRE TIP WAS TRAPPED IN THE LEFT PI PCA LUMEN. IT WAS THOUGHT THAT THE ENTRAPMENT OF THE SUBJECT DEVICE MAY HAVE BEEN CAUSED BY A VESSEL SPASM; SO PAPAVERINE (10 MG OVER 3¿4 MIN) AND NIMODIPINE (1 MG OVER 10 MIN) WERE ADMINISTERED INTRA-ARTERIALLY, BUT THIS DID NOT RESULT IN THE SUCCESSFUL RETRIEVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF A NON-STRYKER STENT ACROSS THE TARGET LESION. COMPLETE REVASCULARIZATION OF THE BA WAS ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3. THEN THE DECISION WAS MADE TO LEAVE THE TRAPPED DEVICE IN PLACE TEMPORARILY FOR 1 DAY CONSIDERING THAT AGGRESSIVE RETRIEVAL PROCEDURE COULD CAUSE THE CEREBRAL VASCULATURE INJURY. AT THE TIME OF CONSCIOUSNESS RECOVERY, THE PATIENT HAD A HEADACHE, DOUBLE VISION AND HEMIPARESIS OF THE RIGHT LIMB. IMAGING IDENTIFIED A SUBARACHNOID HEMORRHAGE (SAH) AT THE INTERPEDUNCULAR CISTERN AND THIS MAY BE RELATED TO THE RUPTURE OF PERFORATOR ARTERIES. THE NEXT MORNING THE PATIENT¿S HEADACHE HAD DISAPPEARED AND IMAGING SHOWED IMPROVEMENT OF THE SAH. THE GUIDEWIRE WAS INADVERTENTLY DISLOCATED FROM THE LEFT PCA DURING MANIPULATION USING A LOOPED CATHETER AND COMPLETELY REMOVED FROM THE PATIENT. IMAGING SHOWED THE SAH SIZE WAS SLIGHTLY INCREASED AFTER THE DEVICE WAS REMOVED BUT THE PATIENT¿S SYMPTOMS REMAINED STABLE. THE PATIENT WAS ASYMPTOMATIC 10 DAYS LATER AND DISCHARGED HOME.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE THAT THE SUBJECT GUIDEWIRE WAS UNEVENTFULLY DELIVERED IN THE P1 SEGMENT OF THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) AND ANGIOPLASTY WAS PERFORMED TO TREAT THE BA STENOSIS. HOWEVER, DURING THE RETRIEVAL OF THE DEVICE, THE GUIDEWIRE TIP WAS TRAPPED IN THE LEFT PI PCA LUMEN. IT WAS THOUGHT THAT THE ENTRAPMENT OF THE SUBJECT DEVICE MAY HAVE BEEN CAUSED BY A VESSEL SPASM; SO PAPAVERINE (10 MG OVER 3¿4 MIN) AND NIMODIPINE (1 MG OVER 10 MIN) WERE ADMINISTERED INTRA-ARTERIALLY, BUT THIS DID NOT RESULT IN THE SUCCESSFUL RETRIEVAL OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF A NON-STRYKER STENT ACROSS THE TARGET LESION. COMPLETE REVASCULARIZATION OF THE BA WAS ACHIEVED WITH A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 3. THEN THE DECISION WAS MADE TO LEAVE THE TRAPPED DEVICE IN PLACE TEMPORARILY FOR 1 DAY CONSIDERING THAT AGGRESSIVE RETRIEVAL PROCEDURE COULD CAUSE THE CEREBRAL VASCULATURE INJURY. AT THE TIME OF CONSCIOUSNESS RECOVERY, THE PATIENT HAD A HEADACHE, DOUBLE VISION AND HEMIPARESIS OF THE RIGHT LIMB. IMAGING IDENTIFIED A SUBARACHNOID HEMORRHAGE (SAH) AT THE INTERPEDUNCULAR CISTERN AND THIS MAY BE RELATED TO THE RUPTURE OF PERFORATOR ARTERIES. THE NEXT MORNING THE PATIENT¿S HEADACHE HAD DISAPPEARED AND IMAGING SHOWED IMPROVEMENT OF THE SAH. THE GUIDEWIRE WAS INADVERTENTLY DISLOCATED FROM THE LEFT PCA DURING MANIPULATION USING A LOOPED CATHETER AND COMPLETELY REMOVED FROM THE PATIENT. IMAGING SHOWED THE SAH SIZE WAS SLIGHTLY INCREASED AFTER THE DEVICE WAS REMOVED BUT THE PATIENT¿S SYMPTOMS REMAINED STABLE. THE PATIENT WAS ASYMPTOMATIC 10 DAYS LATER AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654777 UNKNOWN_NEUROVASCULAR_PRODUCT WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)