BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSERIDER T, 3MM, 10MM ARCH

    MDR report key: 7474434 · Received April 30, 2018

    Report

    Report Number
    3008680601-2018-00533
    Event Type
    Injury
    Date Received
    April 30, 2018
    Date of Event
    April 9, 2018
    Report Date
    April 9, 2018
    Manufacturer
    PULSAR VASCULAR
    Product Code
    NJE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PULSERIDER-ASSISTED COILING OF A 7MM NECK, 8MM (WIDTH) X 7MM (HEIGHT) BASILAR TIP ANEURYSM, THE 3MM, 10MM ARCH PULSERIDER T (211D/W2587-01) ANEURYSM NECK RECONSTRUCTION DEVICE (ARND) WAS PLACED IN A PROWLER SELECT PLUS MICROCATHETER, DELIVERED TO THE TARGET SITE, AND DEPLOYED MULTIPLE TIMES BUT THE ARCH OF THE DEVICE WOULD NOT PROPERLY OPEN INTO THE POSTERIOR CEREBRAL ARTERIES (PCAS). THE DEVICE WOULD NOT FULLY OPEN/EXPAND AS INTENDED AFTER DEPLOYMENT. THE 10MM PULSERIDER T WAS REMOVED FROM THE PATIENT AND REPLACED WITH AN 8MM PULSERIDER T. THE REPLACEMENT DEVICE OPENED UP AS INTENDED. NO PATIENT COMPLICATIONS OCCURRED; HOWEVER, THE SURGERY WAS DELAYED OVER 30 MINUTES DUE TO THE EVENT. IT WAS LAST REPORTED THAT THE PATIENT IS IN ¿GOOD¿ CONDITION. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE VESSEL TORTUOSITY WAS LOW. THE BASILAR VESSEL WAS 2.75. THE CONCOMITANT DEVICES USED DURING THE CASE ARE NOT AVAILABLE FOR RETURN. PROCEDURAL FILMS ARE NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED. THE PULSERIDER WAS RETURNED FOR EVALUATION. THE ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WAS RETRACTED INTO THE INTRODUCER. THE DELIVERY WIRE WAS BENT PROXIMAL TO THE ANRD. THE DEVICE WAS ADVANCED OUT OF THE INTRODUCER. THE ANRD OPENED COMPLETELY. THE DEPLOYED ANRD SHAPE WAS CORRECT FOR A PULSERIDER T DEVICE. THE ARCH AND ANCHOR STRUCTURES WERE INTACT. THE FORK WAS INTACT. THE CRIMPED CONNECTION BETWEEN THE FORK AND DELIVERY WIRE WAS INTACT. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE ANRD DID NOT EXPAND COMPLETELY WAS NOT CONFIRMED. WHEN IT WAS ADVANCED OUT OF THE INTRODUCER, THE ANRD ASSUMED ITS CORRECT T SHAPE. THERE IS NO OBSERVED DAMAGE TO THE PHYSICAL STRUCTURE OF THE DEVICE. THE EXACT CIRCUMSTANCES SURROUNDING THE REPORTED EVENT ARE NOT KNOWN, AND PROCEDURAL FILMS WERE NOT PROVIDED. SINCE THERE IS NO OBSERVABLE ISSUE WITH THE ANRD, IT IS POSSIBLE THAT THE PHYSICAL STRUCTURE OF THE DEPLOYMENT LOCATION WAS NOT A GOOD FIT FOR THE SIZE OR SHAPE OF DEVICE USED. THIS POSSIBILITY IS SUPPORTED BY THE EVENT DESCRIPTION, WHICH INDICATES THAT THE DEVICE WAS REPLACED WITH A SMALLER ANRD, WHICH DID OPEN COMPLETELY. NEITHER THE DEVICE HISTORY RECORD REVIEW NOR THE PRODUCT ANALYSIS SUGGEST THAT THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, IT IS POSSIBLE THAT PROCEDURAL FACTORS AND PATIENT ANATOMY/VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). THE EVENT HAS BEEN DEEMED A "SERIOUS INJURY" DUE TO THE CLINICALLY SIGNIFICANT DELAY IN PROCEDURE (GREATER THAN 30 MINUTES). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PULSERIDER-ASSISTED COILING OF A 7MM NECK, 8MM (WIDTH) X 7MM (HEIGHT) BASILAR TIP ANEURYSM, THE 3MM, 10MM ARCH PULSERIDER T (211D/ W2587-01) ANEURYSM NECK RECONSTRUCTION DEVICE (ARND) WAS PLACED IN A PROWLER SELECT PLUS MICROCATHETER, DELIVERED TO THE TARGET SITE, AND DEPLOYED MULTIPLE TIMES BUT THE ARCH OF THE DEVICE WOULD NOT PROPERLY OPEN INTO THE POSTERIOR CEREBRAL ARTERIES (PCAS). THE DEVICE WOULD NOT FULLY OPEN/EXPAND AS INTENDED AFTER DEPLOYMENT. THE 10MM PULSERIDER T WAS REMOVED FROM THE PATIENT AND REPLACED WITH AN 8MM PULSERIDER T. THE REPLACEMENT DEVICE OPENED UP AS INTENDED. NO PATIENT COMPLICATIONS OCCURRED; HOWEVER, THE SURGERY WAS DELAYED OVER 30 MINUTES DUE TO THE EVENT. IT WAS LAST REPORTED THAT THE PATIENT IS IN ¿GOOD¿ CONDITION. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE VESSEL TORTUOSITY WAS LOW. THE BASILAR VESSEL WAS 2.75. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THE CONCOMITANT DEVICES USED DURING THE CASE ARE NOT AVAILABLE FOR RETURN. PROCEDURAL FILMS ARE NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314772 PULSERIDER T, 3MM, 10MM ARCH INTRACRANIAL NEUROVASCULAR STENT NJE PULSAR VASCULAR W2587-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other