BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITONEAL CATHETER

    MDR report key: 15944105 · Received December 8, 2022

    Report

    Report Number
    2021898-2022-00206
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    September 27, 2019
    Report Date
    December 8, 2022
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    DEL BIGIO, M.R., SIDHU, R.K., KAZINA, C.J., SERLETIS, D. INFLAMMATION AND OBSTRUCTION OF DISTAL CATHETER SLITS IN VENTRICULOPERITONEAL SHUNTS: LIKELY ROLE OF GRAPHITE. J NEUROSURG. 2020. 133 (1495¿1502) DOI: 10.3171/2019.6.JNS191082 OBJECTIVE TISSUE REACTIONS THAT CONTRIBUTE TO OBSTRUCTION OF PERITONEAL CATHETERS IN VENTRICULOPERITONEAL SHUNT SYSTEMS ARE NOT WELL CHARACTERIZED. SEVERAL RECENT RAPID OBSTRUCTIONS IN CHILDREN PROMPTED A RETROSPECTIVE QUALITY ASSURANCE REVIEW. METHODS THE AUTHORS CONDUCTED A DETAILED INVESTIGATION OF 22 SURGICALLY EXPLANTED PERITONEAL SHUNT CATHETERS AND 8 AUTOPSY CASES WITH DOCUMENTED DISTAL SHUNT OBSTRUCTION. PATIENTS¿ MEDICAL HISTORIES WERE REVIEWED, AND THE CATHETERS AND/OR TISSUES WERE SUBJECTED TO CONVENTIONAL HISTOLOGICAL AND IMMUNOHISTOCHEMICAL EVALUATIONS. IN ADDITION, 3 CASES WERE SUBJECTED TO ELECTRON MICROSCOPIC EXAMINATION INCLUDING ELEMENTAL ANALYSIS. RESULTS THE MAJORITY OF SYMPTOMATIC OBSTRUCTIONS WERE ASSOCIATED WITH DISTAL SLIT CATHETERS (17 SLIT, 3 OPEN-END, AND 2 UNKNOWN TYPE). AMONG THE AUTOPSY CASES, DEATHS WERE ATTRIBUTED TO SHUNT FAILURE IN 2 CASES OF SLIT CATHETER OBSTRUCTION, 1 CASE OF OPEN-END CATHETER OBSTRUCTION, AND 1 CASE OF CATHETER WITHDRAWAL FROM THE PERITONEAL CAVITY. THE EARLY TISSUE RESPONSE CONSISTED OF A PREDOMINANTLY T LYMPHOCYTE ACCUMULATION WITH PHAGOCYTOSIS OF GRAPHITE PARTICLES BY MACROPHAGES. THIS IS ASSOCIATED WITH PROLIFERATION OF FIBROBLASTS, MESOTHELIAL CELLS, AND BLOOD VESSELS, WHICH CAN GROW THROUGH THE SLITS AND OCCLUDE THE CATHETER LUMEN. AS THE INFLAMMATION SUBSIDESAFTER APPROXIMATELY 1 YEAR, THE TISSUE PLUG BECOMES COLLAGENIZED AND CALCIFIED. CONCLUSIONS THIS STUDY, SUPPORTED BY EXPERIMENTAL LITERATURE IN OTHER ORGAN SYSTEMS, INDICATES THAT GRAPHITE USED TO COAT THE SLIT OPENINGS OF DISTAL CATHETERS FROM VENTRICULOPERITONEAL SHUNTS LIKELY PREDISPOSES TO OBSTRUCTION. NEUROSURGEONS AND MANUFACTURERS SHOULD CONSIDER THE POTENTIAL NEGATIVE CONSEQUENCES OF THIS SHUNT DESIGN. THE AUTHORS CONCUR WITH PREVIOUS RECOMMENDATIONS THAT SLIT-VALVE DISTAL CATHETERS SHOULD NOT BE USED FOR VENTRICULOPERITONEAL SHUNTING UNLESS THEY CAN BE PROVEN SAFE AND EFFICACIOUS IN A CONTROLLED TRIAL. REPORTABLE EVENTS: MALFUNCTIONING SHUNTS WITH IDENTIFIABLE TISSUE OBSTRUCTIONS 3 CASES WERE SUBCUTANEOUS TISSUE SAMPLES ASSOCIATED WITH SHUNT CATHETER FRACTURE 1 CASE WAS A DISTAL CATHETER OBSTRUCTION CAUSED BY CANDIDA ALBICANS INFECTION. 2 CASES WERE OCCLUDED SLIT-VALVE CATHETERS 1 CASE WAS AN OCCLUDED OPEN-END CATHETER 1 CASE WAS AN OPEN-END CATHETER THAT HAD WITHDRAWN FROM THE PERITONEAL CAVITY 1 CASE THEREWAS AN INFECTION AFTER MORE THAN 7 YEARS IN SITU APPEARED TO HAVE PRECIPITATED FAILURE OF A CATHETER THAT HAD HISTOLOGICAL FEATURES OF CHRONIC OCCLUSION HYDROCEPHALUS WAS DUE TO PROBABLE AQUEDUCT STENOSIS TREATED WITH VENTRICULOPERITONEAL SHUNT (VP) WHEN DECLINE IN COGNITIVE FUNCTION OCCURRED. SHUNT PATENCY STUDY SHOWED DELAYED FLUID FLOW INTO THE ABDOMEN. THE VP SHUNT REVISION OF THE VALVE AND DISTAL CATHETER IN STIU FOR 20 MONTHS. HISTOPATHOLOGY EXAMINATION SHOWED DISTAL CATHETER OBSTRUCTED BY CHRONIC INFLAMMATORY REACTION TO THE GRAPHITE PARTICLES AND MESOTHELIUM. THE TISSUE COMPLICATION HAS BEEN REPORTED IN MULTIPLE CASES OF SHUNT OBSTRUCTION, SOME LEADING TO SURGICAL REVISION, SOME TO DEATH. THE AUTHOR RESPONDED AND STATED THAT THERE ARE ONLY TWO MANUFACTURERS SPECIFY THAT THE DISTAL SLIT VALVES ARE COATED WITH GRAPHITE TO MINIMIZE ADHERENCE DURING STORAGE. OUR NEUROSURGICAL CENTER HAS USED ONLY MEDTRONIC SHUNT PRODUCTS FOR AT LEAST 15 (AND MORE LIKELY >20) YEARS. ALTHOUGH THE AUTHOR DID NOT SPECIFY IN THE PUBLICATION, THEY TRACKED THE OPERATING ROOM (OR) REPORTS IN THE REPORTED CASES FROM RECENT YEARS AND FOUND THAT ALL CATHETERS WERE MEDTRONIC 43522. SINCE THEY IDENTIFIED THE PROBLEM, OUR SURGEONS HAVE BEEN AMPUTATING THE END OF THE CATHETERS TO CREATE A SIMPLE OPEN-END CATHETER. NOTE THAT REMOVAL OF SLIT VALVES HAS BEEN ADVOCATED BY OTHERS, ALTHOUGH THEY HAD NOT SPECIFICALLY STUDIED THE BIOLOGY. THE AUTHOR HAS SEEN AT LEAST 5 MORE SUCH CASES SINCE THE PUBLICATION (IMPLANTATION PREDATING OUR REMOVAL OF THE SLIT VALVES). THERE HAVE BEEN 10 CASES SINCE THE PUBLICATION. IT WAS STATED THAT THE THERE WAS A SHUNT FAILURE. THESE ARE ALL CASES OF SHUNT FAILURE CAUSED BY TISSUE INGROWTH INTO THE DISTAL (PERITONEAL) END OF VENTRICULOPERITONEAL SHUNTS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE AUTHORS "CONCERN ABOUT THE POTENTIAL NEGATIVE ASPECTS OF DISTAL SLIT VALVES AND PARTICULARLY GRAPHITE ARE BASED UPON LONG-STANDING OBSERVATIONS AND INTEREST ABOUT SHUNT OBSTRUCTION (BEGINNING C1984)." THEY ALSO STATED THAT THEY CONTINUE TO ACCRUE PUBLISHED INFORMATION ABOUT GRAPHITE / CARBON NANOPARTICLES AND THE RISK OF INFLAMMATION / MESOTHELIOMA. AND THAT THE EVIDENCE IS STRONGER NOW THAN WHEN THEY WROTE THEIR ARTICLE IN 2019 (PUBLISHED IN 2020). THE AUTHOR STATED THAT "UNFORTUNATELY SHUNT OBSTRUCTION WAS COMMON AND THAT IT HAS BECOME AN ACCEPTED RISK AND NOT CONSIDERED A TECHNOLOGY FAILURE. THIS IS A CONSEQUENCE OF THE FDA LABELING SHUNTS AS A CLASS 2 DEVICE WHEREIN FAILURES NEED NOT BE REPORTED AND NEW TECHNOLOGIES CAN BE MARKETED IF THEY ARE SIMILAR TO PRIOR TECHNOLOGIES. RIGOROUS PRECLINICAL EXPERIMENTATION AND CLINICAL TRIALS ARE NOT NECESSARY." THERE ARE ANECDOTAL REPORTS OF ALLERGY TO UNPOLYMERIZED SILICONE AND AVOIDANCE OF REPEATED OBSTRUCTIONS BY USE OF THE EXTRACTED CATHETER. MEDTRONIC HAD BEEN A SUPPLIER OF ¿EXTRACTED¿ SHUNTS, IN WHICH UNPOLYMERIZED SILICONE IS REMOVED BY REPEATED SOLVENT EXTRACTION CYCLES. THIS PROCESSING IS EXPENSIVE, BUT THEORETICALLY COULD BE MARKETED APPROPRIATELY IF THERE WAS PRECLINICAL AND CLINICAL STUDIES TO SHOW SUPERIORITY. THE AUTHOR STATED THAT THEY BELIEVE THAT INFLAMMATION FORMS THE BASIS OF MOST SHUNT OBSTRUCTION. TO WHAT EXTENT THIS IS A REACTION TO SILICONE IN ITS FULLY POLYMERIZED VS. UNPOLYMERIZED FORMS VS. ADDITIVES SUCH AS BARIUM SULFATE IS NOT CLEAR. TO SOME EXTENT THIS COULD BE ADDRESSED IN SOME FAIRLY SIMPLE ANIMAL EXPERIMENTS. A SIMPLE DISTAL OPEN-END CATHETER WITHOUT ANY SLIT VALVES (OR THE GRAPHITE) WOULD BE LESS EXPENSIVE TO MANUFACTURE. THEY BELIEVE THAT IT MIGHT IMPROVE PATIENT SAFETY. MANY NEUROSURGEONS ARE ALREADY CUTTING OF THE SLIT VALVE SEGMENT AND MOST COMPETITORS DO NOT USE THEM. NOBODY HAS EVEN PROVEN SUPERIORITY OR NON-INFERIORITY OF DISTAL CATHETER CONFIGURATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585820 PERITONEAL CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY 43522 C82517

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male