BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 777084 · Received November 1, 2006

    Report

    Report Number
    6000078-2006-00538
    Event Type
    Injury
    Date Received
    November 1, 2006
    Date of Event
    October 10, 2006
    Report Date
    October 10, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV
    Product Code
    NJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN REPORTED THE PT'S SAH AND BRAIN STEM COMPRESSION WERE BOTH SYMPTOMS UNRELATED TO THE COMPLAINT. NO INFO WAS REPORTED INDICATING THAT THE PT'S CONDITION WAS WORSENED AS A RESULT OF THIS PHENOMENON. IN ADDITION, THERE WAS NO INFO PROVIDED THAT INDICATED THE PT EXPERIENCED ANY ADD'L ADVERSE EFFECTS. PMA/510(K): H020002/S4, H020002/S5. THE DEVICE IN QUESTION HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE PT WAS SUFFERING FROM A SUBARACHNOID HEMORRHAGE (SAH) PRIOR TO TREATMENT, AND A BRAIN STEM COMPRESSION. DURING PREPARATION, THE PHYSICIAN NOTICED THAT A SMALL AMOUNT OF WATER HAD EXITED AT THE PROXIMAL HUB OF THE DELIVERY CATHETER., AND THAT A MAJORITY OF THAT FLUSH EXITED AT THE DISTAL TIP. THE PHYSICIAN REPORTED HE DECIDED HE WAS ABLE TO POSITION THE SYSTEM ACROSS THE ANEURYSM. HOWEVER, THE PHYSICIAN WAS UNABLE TO DEPLOY THE STENT. THE PHYSICIAN REPORTED THAT WHEN HE APPLIED ADD'L PRESSURE ON THE STABILIZER, THE STABILIZER KNIKED. THE PHYSICIAN REPORTED IT THEN BECAME IMPOSSIBLE TO MOVE THE STENT WITHIN THE DELIVERY CATHETER. THE PHYSICIAN REPORTEDLY REMOVED THE SYSTEM, AND COMPLETED THE PROCEDURE WITH THE USE OF ANOTHER SIMILAR SYSTEM WITHOUT ANY FURTHER COMPLICATIONS. THE PHYSICIAN REPORTED THAT THE PT'S SAH AND BRAIN STEM COMPRESSION WERE BOTH SYMPTOMS UNRELATED TO THE COMPLAINT. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM (NJE) INTRAVASCULAR STENT NJE BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV E345030 8989544

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R