MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY PERITONEAL CATHETER, STANDARD, 90 CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 43522

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 43522, lot #: e42443, product type: catheter.Product id: 23047, lot #: unknown, product type: catheter.Sex: please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.For any further information received regarding these events, previously reported regulatory reports 2021898-2019-00084, 2021898-2019-00082, and 2021898-2019-00083 will be reported under this current regulatory report.If information is provided in the future, a supplemental report will be issued.

Event Description

Marc r.Del bigio, ravinder k.Sidhu, colin j.Kazina, demitre serletis.Inflammation and obstruction of distal catheter slits in ventriculoperitoneal shunts: likely role of graphite.Journal of neurosurgery 2019.Abstract: object - 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 - we conducted a detailed investigation of 22 surgically explanted peritoneal shunt catheters and 8 autopsy cases with documented distal shunt obstruction.Histories were reviewed and the catheters and / or tissues were subjected to conventional histologic and immunohistochemical evaluations.In addition, three 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, 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 consists 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 subsides after 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.We concur with previous authors¿ 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.Reported events.A (b)(6) female with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the lumen contained macrophages, neutrophils, blood, early giant cells, and rare flecks of graphite but no microorganisms.A (b)(6) male with a hydrocephalus etiology of cas had their distal catheter surgically explanted.Histologic features showed the slit and lumen 6 cm from end obstructed.Lumen occluded by vascularized collagenous tissue with fibroblasts, some mesothelial cells (ck+), many multinucleate giant cells contacting inner surface of catheter (cd68+, hla-dr+), many t lymphocytes (cd3+; cd4 > cd8), very rare b lymphocytes (cd20+), rare eosinophils, very rare plasma cells (cd138+), very rare mast cells (cd117+), and proliferating mesenchymal and inflammatory cells throughout viable tissue (ki67+).The core has early calcification and ghosts of dead cells.Vascularized pedicle traverses the catheter slit.Particulate graphite with refractile orthogonal and needle-like crystals clustered near one end of the tissue; some graphite engulfed by giant cells or surrounded by inflammatory cells.A (b)(6) male with a hydrocephalus etiology of subarachnoid hemorrhage had their distal catheter surgically explanted.Histologic features showed filmy soft tissue occluding the end hole.Loosely organized proteinaceous with multinucleated macrophages at contact surface.Rare particles of graphite in giant cells.A (b)(6) male with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the second (of three) slits and lumen obstructed.Lumen plug was cellular at the contact surface and more collagenous in the core with abundant dispersed graphite, hemosiderin, and focal calcification.The external capsule is more cellular with mesothelial cells, rare t lymphocytes (cd3+, cd4+), rare giant cells (cd68+), and small foci of graphite particles in macrophages.Proliferating cells (ki67+) abundant on capsule surface facing the peritoneum.No neutrophils, eosinophils, plasma cells, b lymphocytes, or microorganisms.A (b)(6) female with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the single slit and lumen obstructed.Tissue in lumen at contact surfaces highly cellular with mesothelial cells (ck+), fibroblasts, endothelial cells, many macrophages and rare giant cells (cd68+, hla-dr+), fine graphite particles in and near macrophages, small clusters of t lymphocytes (cd3+), rare mast cells (cd117+), and rare eosinophils.Core less cellular with calcified material and dense graphite aggregate.Proliferating cells (ki67+) near surface - mesothelial and inflammatory cells.No neutrophils, b lymphocytes, or plasma cells.A (b)(6) male with a hydrocephalus etiology of adult onset idiopathic had their distal catheter surgically explanted.Histologic features showed small pieces of soft tissue at the end.Lumen plugged by fibrovascular tissue with highly cellular surface including mesothelial cells, macrophages with and without phagocytosed graphite particles, rare t lymphocytes, and rare proliferating cells (ki67+).No eosinophils.Core less cellular with dense graphite aggregate and early calcification.A (b)(6) female with a hydrocephalus etiology of mmc-h had their distal catheter surgically explanted.Histologic features showed the slit and lumen 7 cm from tip obstructed.Plug of tissue has acellular collagenous core; surface more cellular with many multinucleated giant cells, and abundant intra- and extra-cellular graphite (especially near slits), rare eosinophils and t lymphocytes.A (b)(6) male with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the slit and lumen 6.5 cm from tip obstructed by collagenous tissue with abundant graphite.Radial pedicles through all four slits connect to more cellular sheath.On external contact surface rare lymphocytes, few multinucleated giant cells, and many neutrophils.No microorganisms identified but infection suspected.A (b)(6) male with a hydrocephalus etiology of tuberculosis meningitis 2 years prior had their distal catheter surgically explanted.Histologic features showed the lumen obstructed by collagenous tissue with graphite.A (b)(6) male with a hydrocephalus etiology of dandy-walker malformation had their distal catheter surgically explanted.Histologic features showed large peritoneal pseudocyst developed over 1 month, catheter not obstructed.Tissue wall (1-2mm thick) fibrovascular with granulomatous inflammation.T lymphocytes dispersed throughout but more abundant on the vascularized mesothelial surface, along with rare b lymphocytes and plasma cells.Macrophages abundant at surface oriented toward the shunt.Rare giant cells in wall.No eosinophils, no microorganisms, no graphite, no silicone fragments.A (b)(6) male with a hydrocephalus etiology of cas had their distal catheter surgically explanted.Histologic features showed single slit and lumen obstructed by fibrovascular tissue.Core was acellular with flattened giant cells at contact surfaces; abundant graphite throughout core and pedicles.A (b)(6) male with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the lumen obstructed at distal slit, gelatinous material adherent to slits.Lumen contained collagenous material with fibroblasts near contact surface; small fragments of mesothelial cells on outside; no inflammation, no graphite.A (b)(6) male with a hydrocephalus etiology of possible cas had their distal catheter surgically explanted.Histologic features showed fibrous adhesions on external surface and small tissue plug in lumen.Collagenous tissue with blood vessels, multinucleated giant cells, very rare t lymphocytes, and small flecks of calcium.A (b)(6) male with a hydrocephalus etiology of cas had their distal catheter surgically explanted.Histologic features showed fibrous tissue sheath around distal 5cm of catheter; no tissue in lumen.Collagenous tissue with focal calcification and a few fibroblasts on external surface; no inflammation, no microorganisms.A (b)(6) male with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the lumen occluded from open tip to single slit valve.Acellular collagenous tissue with dense aggregates of graphite and focal calcification.Very rare t lymphocytes and macrophages at contact surface.A (b)(6) male with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the lumen occluded from open tip to single slit valve.Mainly acellular collagenous tissue with dense aggregates of graphite and extensive calcification.Tissue pedicles have viable mesothelial cells on external surface.A (b)(6) male with a hydrocephalus etiology of cas had their distal catheter surgically explanted.Histologic features showed the distal 7cm encased by tissue and lumen plugged.External sheath collagenous and cellular tissue with focal calcification.Lumen occluded by acellular collagenous material, rare graphite particles.Vascularized pedicles of cellular tissue traverse the slits, rare giant cells and neutrophils.Gram positive cocci.Infection precipitated obstruction of chronic growth.A (b)(6) male with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the lumen occluded at single slit.Plug was mix of acellular and calcified material.Fibrovascular tissue extends through slits.Multinucleated giant cells surround silicone fragments near contact surface.No graphite.A (b)(6) male with a hydrocephalus etiology of congenital (not as) had their distal catheter surgically explanted.Histologic features showed the external surface tissue at slits 4 and 10 cm from end, minimal tissue in lumen.Dense collagenous capsule with calcium deposits adjacent to the catheter; outer surface attached mesothelium and omentum.No inflammation and no graphite.A (b)(6) male with a hydrocephalus etiology of mmc-h had their distal catheter surgically explanted.Histologic features showed the slit and lumen 7cm from end obstructed.Collagenous tissue with flattened macrophages and very rare giant cells along contact surface, small foci of calcium.Rare graphite embedded in acellular collagen.No inflammation.A (b)(6) female with a hydrocephalus etiology of p-ivh had their distal catheter surgically explanted.Histologic features showed the tissue inside and outside of catheter.Lumen contained macrophages, giant cells, lymphocytes, and a few blood vessels.Acellular, partially calcified material on outside.No graphite, neutrophils, or microorganisms.A (b)(6) male with a hydrocephalus etiology of possible cas had their distal catheter surgically explanted.Histologic features showed the terminal lumen occluded by firmly attached pale tissue.Collagenous with calcification and rare fragments of silicone debris.No graphite or inflammation.

• Brand Name: PERITONEAL CATHETER, STANDARD, 90 CM
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8793326
• MDR Text Key: 151124545
• Report Number: 2021898-2019-00278
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K792005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 43522
• Device Catalogue Number: 43522
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention