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 Abdominal Pain (1685); Apnea (1720); Death (1802); Headache (1880); Inflammation (1932); Pneumonia (2011); Seizures (2063); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Malaise (2359); Irritability (2421); Lethargy (2560); Abdominal Distention (2601)

Event Type  Death  

Manufacturer Narrative

Other applicable components are: product id: unknown-c, serial/lot #: unknown.Product id: 43522, serial/lot #: (b)(4).Product id: 23047, serial/lot #: unknown.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) male with a hydrocephalus etiology of mmc-h with a history of vomiting and sudden death due to distal shunt malfunction.Histologic features showed the ventricular catheter patent.Catheter tip in right upper abdomen surrounded by adherent tissues occluding the slits; no flow through tube.Core tissue was collagenous with calcium and abundant graphite.Pedicles through slits were collagen with graphite.Sheath had mesothelial cells, focal calcification, rare eosinophils, abundant multinucleated giant cells, rare t lymphocytes.A (b)(6) male with a hydrocephalus etiology of nph with a history of subdural hematoma (acute on chronic) died.Histologic features showed the ventricular catheter patent.Tissue adhesion along 10 cm of distal catheter (multiple slits); dense adhesion at middle slit caused 180° angulation, most proximal slit patent.Lumen plug was collagenous with hemosiderin.Pedicles are collagenous with graphite-containing macrophages and foci of lymphocytes with rare plasma cells).Sheath was collagenous with rare foreign body giant cells at contact surface.A (b)(6) female with a hydrocephalus etiology of p-ivh with a history of cerebral palsy, irritable, and abdominal pain for 1 month died.Ventricles were large but compared to a ct scan from 7 years earlier.Cause of death was undetermined.Histologic features showed the ventricular catheter patent.Distal catheter ended in abdominal subcutaneous fat; multiple intestinal adhesions abdominal tissue surrounding the shunt catheter is collagenous with small foci of calcification and negligible inflammation.A (b)(6) female with a hydrocephalus etiology mmc-h with a history of severe headaches, and vomiting died.Acute hydrocephalus secondary to distal shunt malfunction.Histologic features showed the ventricular catheter patent.No fluid flow through distal catheter.Tip obstructed by firmly attached cylindrical tissue plug.No histology done.A (b)(6) male with a hydrocephalus etiology of neonatal meningitis with a history of pseudocyst at 1 year, vomiting, lethargy, and sudden respiratory arrest due to distal shunt malfunction.Histologic features showed the ventricular catheter patent.Distal catheter ends 7 cm below rib margin; distended fibrous subcutaneous capsule extends into abdomen.Extensive peritoneal adhesions.Tissue around catheter collagenous with focal giant cells; no eosinophils, no lymphocytes.A (b)(6) male with a hydrocephalus etiology of congenital hydrocephalus with a history of abdominal surgery 3 months prior to death.Prior ct scans showed gradually enlarging ventricles and headaches.Cause of death was determined to be due to distal shunt malfunction.Histologic features showed the ventricular catheter patent.Distal catheter in peritoneal cavity surrounded by dense collagenous capsule with adhesions and kink at proximal slit; lumen patent.Rare macrophages and mesothelial cells at interface, scattered eosinophils, scattered lymphocytes, rare multinucleated giant cells; no neurtophils.A (b)(6) female with a hydrocephalus etiology of craniopharyngioma with a history of hypopituitarism and flu-like symptoms for 1 day died.Last ct scan was 9 years before death.The patient experienced pneumonia, and their ventricles were small.Histologic features showed the proximal catheter occluded by glial tissue.Distal catheter occluded by plug of acellular collagenous material with graphite and calcification.Pedicles through slits were collagen with graphite.External sheath is collagenous with mesothelium, focal graphite, rare clusters of t lymphocytes, and rare macrophages.A (b)(6) female with a hydrocephalus etiology of mmc-h with a history of epilepsy, esophageal ulcer hemorrhage, and gradually enlarging ventricles for 5 years died.Histologic features showed the ventricular catheter patent.Subcutaneous tract heavily calcified.Distal catheter embedded in pericolic fat with adhesions between loops of small intestine.Delicate collagenous sheath with a few multinucleated giant cells, rare t lymphocytes, and rare macrophages.

• 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: 8793470
• MDR Text Key: 151129024
• Report Number: 2021898-2019-00279
• 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

• Date FDA Received: 07/16/2019
• 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
• Date Manufacturer Received: 06/19/2019
• 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): Death