BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CODMAN BICOL SPONGE

    MDR report key: 10326542 · Received July 27, 2020

    Report

    Report Number
    1226348-2019-00505
    Event Type
    Injury
    Date Received
    July 27, 2020
    Report Date
    October 9, 2019
    Manufacturer
    RAYNHAM
    Product Code
    GEL
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SPONGES WERE NOT RETURNED FOR EVALUATION AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    STROKE JOURNAL (2003) PUBLISHED: CRANIOTOMY FOR TREATMENT OF UNRUPTURED ANEURYSMS IS NOT ASSOCIATED WITH LONG-TERM COGNITIVE DYSFUNCTION PURPOSE¿ MANY STUDIES HAVE REPORTED FREQUENT COGNITIVE DEFICITS ASSOCIATED WITH SUBARACHNOID HEMORRHAGE (SAH) AND ANEURYSM REPAIR. ONE STUDY FOUND MORE SEVERE COGNITIVE DEFICITS AFTER CLIPPING THAN COILING OF ANEURYSMS, RAISING THE POSSIBILITY THAT DEFICITS ARE DUE TO SURGERY INSTEAD OF SAH ITSELF. THIS POSSIBILITY WAS DIRECTLY ADDRESSED BY EVALUATING THE COGNITIVE EFFECTS OF SURGERY WITHOUT SAH. THE GOAL OF THIS STUDY WAS TO IDENTIFY CHANGES IN COGNITIVE FUNCTION ASSOCIATED WITH SURGICAL CLIPPING OF UNRUPTURED INTRACEREBRAL ANEURYSMS. METHODS¿ A CONSECUTIVE SERIES OF 25 PATIENTS WHO UNDERWENT SURGICAL CLIPPING OF ONE(1) UNRUPTURED INTRACEREBRAL ANEURYSM WERE TESTED WITHIN 1 WEEK PREOPERATIVELY AND AGAIN POSTOPERATIVELY (BEFORE HOSPITAL DISCHARGE AND AT 3-MONTH FOLLOW-UP IF THEY HAD DEFICITS AT DISCHARGE) ON A NEUROPSYCHOLOGICAL BATTERY. DIFFERENT FORMS OF EACH TEST WERE USED PREOPERATIVELY AND POSTOPERATIVELY TO REDUCE PRACTICE EFFECTS. PAIRED T TESTS WERE USED TO EXAMINE DIFFERENCES BETWEEN PREOPERATIVE AND POSTOPERATIVE TEST SCORES ACROSS INDIVIDUALS. THE BICOL SPONGE WAS USED IN THE SURGICAL PROCEDURES AS BRAIN PROTECTION ALONG WITH A COMPETITOR PRODUCT (TELFA). THE LITERATURE DOESN'T STATES THAT THE ADVERSE EVENTS WERE RELATED TO THE PRODUCT (BICOL) ITSELF. ADVERSE EVENTS: STUDY GROUP: MAJOR STROKE (1) - THIS PATIENT HAD PRESENTED ORIGINALLY WITH A LEFT FRONTAL STROKE FROM A MIDDLE CEREBRAL ARTERY (MCA) EMBOLUS AND WAS FOUND AT THE TIME TO HAVE AN INCIDENTAL LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM. POSTOPERATIVELY, ALTHOUGH SHE DID WELL INITIALLY, SHE DEVELOPED A DELAYED HEMORRHAGE INTO HE AREA OF THE PREVIOUS STROKE AND A NEW WATERSHED STROKE IN THE LEFT MCA/POSTERIOR CEREBRAL ARTERY DISTRIBUTION THAT REQUIRED A SECOND CRANIOTOMY FOR EVACUATION OF THE INTRAPARENCHYMAL HEMATOMA AND A LIMITED ANTERIOR FRONTAL LOBECTOMY. MINOR STROKE (1) - THIS PATIENT HAD A PROXIMAL MCA ANEURYSM AND SUFFERED A LIMITED LENTICULOSTRIATE PERFORATOR STROKE THE RESULTED IN AN ISOLATED MILD RIGHT HEMIPARESIS. TRANSIENT DEFICIT (1) - DEFINED AS MINOR SENSORY OR MOTOR DEFICITS THAT RESOLVED 2 TO 3 DAYS AFTER SURGERY AND WERE ATTRIBUTED TO TRANSIENT EDEMA OR RETRACTION. RESULTS¿ THERE WAS NO SIGNIFICANT CHANGE BETWEEN PREOPERATIVE AND POSTOPERATIVE SCORES. A SIGNIFICANT DECLINE IN ACCURACY BEFORE HOSPITAL DISCHARGE WAS FOUND ONLY IN FIGURE COPYING AND ASSOCIATIVE LEARNING, AND SIGNIFICANT SLOWING WAS FOUND ON 1 TEST. EVEN ON THESE TESTS, ONLY 3 OF 25 PATIENTS SHOWED SIGNIFICANT DETERIORATION. ALL BUT 1 PATIENT RETURNED TO BASELINE BY THE 3-MONTH FOLLOW-UP. CONCLUSIONS¿ WE FOUND NO EVIDENCE OF SUBTLE COGNITIVE DEFICITS RESULTING FROM ANEURYSM CLIPPING ALONE, SUGGESTING THAT THE COMMON IMPAIRMENTS AFTER SURGERY FOR RUPTURED ANEURYSMS ARE DUE TO SAH ITSELF, COMPLICATIONS OF SAH SUCH AS VASOSPASM OR HYDROCEPHALUS, OR PERIOPERATIVE STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790445 UNKNOWN CODMAN BICOL SPONGE BICOL GEL RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1