BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATA®

    MDR report key: 12928849 · Received December 3, 2021

    Report

    Report Number
    2021898-2021-00208
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    April 22, 2021
    Report Date
    December 3, 2021
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    AHMAD SWEID, BADIH J. DAOU, JOSHUA H. WEINBERG, ROBER TM. STARKE, ROBERT C. SERGOTT, JOSEPH SCHAEFER, JULIE HAUGE, CAROLINE ELIZABETH, NOHRA CHALOUHI, REID GOOCH, NABEEL HERIAL, HEKMAT ZARZOUR, PASCAL JABBOUR, ROBERT H. ROSENWASSER, STAVROPOULA TJOUMAKARIS. EXPERIENCE WITH VENTRICULOPERITONEAL AND LUMBOPERITONEAL SHUNTING FOR THE TREATMENT OF IDIOPATHIC INTRACRANIAL HYPERTENSION: A SINGLE INSTITUTION SERIES. OPERATIVE NEUROSURGERY 21 (2021). DOI: 10.1093/ONS/OPAB106 BACKGROUND: CSF SHUNTING IS AMONG THE MOST WIDELY UTILIZED INTERVENTIONS IN PATIENTS WITH IDIOPATHIC INTRACRANIAL HYPERTENSION (IIH). VENTRICULOPERITONEAL SHUNTING (VPS) AND LUMBOPERITONEAL SHUNTING (LPS) ARE 2 POSSIBLE TREATMENT MODALITIES. OBJECTIVE: TO EVALUATE AND COMPARE COMPLICATIONS, MALFUNCTION, INFECTION, AND REVISION RATES ASSOCIATED WITH VPS COMPARED TO LPS. METHODS: ELECTRONIC MEDICAL RECORDS WERE REVIEWED TO IDENTIFY BASELINE AND TREATMENT CHARACTERISTICS FOR PATIENTS DIAGNOSED WITH IIH TREATED WITH VPS OR LPS. RESULTS: A TOTAL OF 163 PATIENTS TREATED WITH EITHER VPS (74.2%) OR LPS (25.8%) WERE IDENTIFIED. THE MEAN FOLLOW-UP WAS 35MO. SHUNT REVISION WAS REQUIRED IN 40.9% OF PATIENTS. THERE WAS A NONSIGNIFICANT HIGHER RATE OF REVISION WITH LPS (52.4%) THAN VPS (36.4%, P=.07). IN MULTIVARIATE ANALYSIS, INCREASING PATIENT AGE WAS ASSOCIATED WITH HIGHER ODDS OF SHUNT REVISION (P = .04). LPS HAD HIGHER ODDS OF SHUNT REVISION, YET THIS ASSOCIATION WAS NOT SIGNIFICANT (P = .06). SHUNT MALFUNCTION WAS THE MAIN INDICATION FOR REVISION OCCURRING IN 32.7%, WITH A SIGNIFICANTLY HIGHER RATE WITH LPS THAN VPS (P = .03). IN TOTAL, 15 PATIENTS HAD SHUNT INFECTION (9.4% VPS VS 12.2% LPS P=.50). THE ONLY SIGNIFICANT PREDICTOR OF PROCEDURAL INFECTION WAS THE INCREASING NUMBER OF REVISIONS (P = .02). CONCLUSION: THE INCIDENCE OF SHUNT REVISION WAS 40.9%, WITH INCREASING PATIENT AGE AS THE SOLE PREDICTOR OF SHUNT REVISION. THE INCIDENCE OF SHUNT MALFUNCTION WAS SIGNIFICANTLY HIGHER IN PATIENTS UNDERGOING LPS, WHILE THERE WAS NO SIGNIFICANT DIFFERENCE IN THE INCIDENCE OF SHUNT INFECTION BETWEEN THE 2 MODALITIES. REPORTED EVENTS: - SHUNT REVISION WAS REQUIRED IN 65 OUT OF 159 PATIENTS WITH FOLLOW-UP (40.9%). ONE SHUNT REVISION WAS PERFORMED IN 40 PATIENTS (25.2%), WHEREAS MULTIPLE SHUNT REVISIONS WERE PERFORMED IN 25 PATIENTS (15.7%), FOR A TOTAL OF 110 REVISIONS. A REVISION WAS NECESSARY TO REPOSITION PROXIMAL OR DISTAL CATHETERS, REPLACE THE SHUNT COMPONENTS, OR REMOVE THE ENTIRE SYSTEM BECAUSE OF SHUNT MALFUNCTION OR INFECTION. SHUNT MALFUNCTION OCCURRED IN 52 PATIENTS (32.7%), WITH A SIGNIFICANTLY HIGHER RATE WITH LPS (18/41 PATIENTS, 43.9%) THAN VPS (34/118 PATIENTS, 28.8%, P = .03). SHUNT MALFUNCTION REPRESENTED THE INDICATION FOR SHUNT REVISION IN 95/110 REVISIONS (86.4%). THE MAIN REASONS FOR SHUNT MALFUNCTION WERE DUE TO SHUNT MALPOSITION, MIGRATION, AND DISPLACEMENT (37.3%), FOLLOWED BY SHUNT OBSTRUCTION (15.4%), VALVE DYSFUNCTION (8.2%), AND OVERDRAINAGE (5.4%). A TOTAL OF 66 REVISIONS WERE RELATED TO DISTAL CATHETER MALFUNCTION (60%), AND 11 REVISIONS WERE RELATED TO PROXIMAL CATHETER MALFUNCTION (10%). A TOTAL OF 15 PATIENTS HAD SHUNT INFECTION (9.4%), OF WHICH 3 (1.9%) WERE PROXIMAL, AND 12 WERE DISTAL (7.5%). SHUNT INFECTION REPRESENTED THE INDICATION FOR SHUNT REVISION IN 15/110 PATIENTS (13.6%). OTHER COMPLICATIONS ENCOUNTERED ARE 1 CASE OF ACQUIRED CHIARI MALFORMATION, 1 CASE OF PERIPHERAL CN VII PALSY, 1 CASE OF PSEUDOMENINGOCELE, 1 CASE OF SUBDURAL HYGROMA, 2 CASES OF WOUND INFECTION (1 IN LPS AND 1 IN VPS), AND 1 CASE OF INTRACEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826279 STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY UNKNOWN-S UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R