MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-C

Device Problem Migration (4003)

Patient Problems Swelling (2091); Vomiting (2144); Complaint, Ill-Defined (2331); Lethargy (2560)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Ahmed a.M.Ezzat, mohamed a.R.Soliman, amr a.Hasanain1, mohamed a.Thabit, hesham elshitany, haitham kandel, sameh h.Abdel-bari, ahmed m.F.Ghoul, ahmed abdullah, mohamed f.M.Alsawy, ammar a.Ghaleb, ahmed al menabbawy, ahmed a.Marei, bassante abd el razik, henry w.S.Schroeder, sascha marx, ahmed zohdi, ehab el refaee.Migration of the distal catheter of ventriculoperitoneal shunts in pediatric age group: case series.World neurosurger (2018).Doi: 10.1016/j.Wneu.2018.07.073 - background: ventriculoperitoneal (vp) shunting is the most commonly performed procedure in the treatment of hydrocephalus.Vp shunt migration can occur at different sites.The aim of the study was to present different sites of abnormal distal shunt location, pathophysiology, and the management in each situation.Methods: between 2014 and 2017, all patients with hydrocephalus in the department of neurosurgery, cairo university, were gathered prospectively.All pediatric patients below the age of 12 years with shunt migration of the distal end of the vp shunt were identified.Results: of 1092 patients operated on by the vp shunt between 2014 and 2017, 15 presented with shunt dysfunction because of distal shunt migration (6 anal, 3 scrotal, 1 colon, 1 peroral, 1 upper lumbar extrusion, 1 paraspinal, 1 penile, and 1 umbilical).Especially upper lumbar extrusion and paraspinal shunt location are extremely rare.All the 15 patients were treated successfully with vp shunts and prospectively followed until they presented with complications on different occasions.Conclusions: peritoneal complications are among the most common causes of vp failure.We present a rare complication where the shunt migrates outside the peritoneal cavity elsewhere with ambiguous pathogenesis.Special considerations have to be appointed during the shunt revision surgeries of these cases.Reported events.One of the 15 patients was reported to have the manufacturer's device; however, it is unclear which patient had that device.A 22 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was the retroperitoneal into the lumbar region.The distal end had been inserted by a laparotomy.The shunt migration had occurred after 3 revisions.The symptoms at the time of presentation of the migration were vomiting and back swelling.The patient showed ventriculomegaly in the radiological workup.The patient had a previous distal revision at which a connector was implanted to accomplish lengthening of the distal end, which is required in some shunt materials that have a slit end release.The laparoscopic revision was performed at which the connector was found implanted within the posterior lumbar muscles where the distal end was retracted from the posterior lumbar area and reinserted in the peritoneal cavity.A 27 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was the colon.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were lethargy, vomiting, and bulging anterior fontanel.The patient showed multiloculated hydrocephalus in the radiological workup.Direct repair of the intestinal wall was performed where the csf was externally diverted for 1 week.Then a vp shunt was reinserted in the right iliac fossa after exclusion of peritoneal inflammation.A 3 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was scrotal.The distal end had been inserted by a laparotomy.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were scrotal swelling.The patient showed ventriculomegaly in the radiological workup.Laparoscopic pulling through the internal ring and repositioning into the peritoneum was performed.The patient had a favorable outcome.A 3 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was scrotal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were vomiting, bulging anterior fontanel, and scrotal swelling.The patient showed ventriculomegaly in the radiological workup.Laparoscopic pulling through the internal ring and repositioning into the peritoneum was performed.The patient had a favorable outcome.A 2 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was scrotal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were bulging anterior fontanel and scrotal swelling.The patient showed ventriculomegaly in the radiological workup.Laparoscopic pulling through the internal ring and repositioning into the peritoneum was performed.The patient had a favorable outcome.A 7 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was anal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were vomiting, bulging anterior fontanel and protruded shunt from the anus.The patient showed ventriculomegaly in the radiological workup.The shunt tube was removed from an anal route (cutting the distal end in the peritoneum before penetrating the hollow organ), followed by repair of the intestinal defect, and csf was externally diverted for 1 week.Then a vp shunt was reinserted after exclusion of peritoneal inflammation.A 12 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was anal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were vomiting, bulging anterior fontanel and protruded shunt from the anus.The patient showed ventriculomegaly in the radiological workup.The shunt tube was removed from an anal route (cutting the distal end in the peritoneum before penetrating the hollow organ), followed by repair of the intestinal defect, and csf was externally diverted for 1 week.Then a vp shunt was reinserted after exclusion of peritoneal inflammation.A 22 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was anal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were lethargy, vomiting, and protruded shunt from the anus.The patient showed ventriculomegaly in the radiological workup.The shunt tube was removed from an anal route (cutting the distal end in the peritoneum before penetrating the hollow organ), followed by repair of the intestinal defect, and csf was externally diverted for 1 week.Then a vp shunt was reinserted after exclusion of peritoneal inflammation.A 7 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was anal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were protruded shunt from the anus.The patient showed normal ventricular size in the radiological workup.The shunt tube was removed from an anal route (cutting the distal end in the peritoneum before penetrating the hollow organ), followed by repair of the intestinal defect, and csf was externally diverted for 1 week.Then a vp shunt was reinserted after exclusion of peritoneal inflammation.A 6 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was anal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were vomiting, bulging anterior fontanel and protruded shunt from the anus.The patient showed ventriculomegaly in the radiological workup.The shunt tube was removed from an anal route (cutting the distal end in the peritoneum before penetrating the hollow organ), followed by repair of the intestinal defect, and csf was externally diverted for 1 week.Then a vp shunt was reinserted after exclusion of peritoneal inflammation.A 3 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was anal.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were vomiting and protruded shunt from the anus.The patient showed ventriculomegaly in the radiological workup.The shunt tube was removed from an anal route (cutting the distal end in the peritoneum before penetrating the hollow organ), followed by repair of the intestinal defect, and csf was externally diverted for 1 week.Then a vp shunt was reinserted after exclusion of peritoneal inflammation.A 22 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was peroral.The distal end had been inserted using a trocar.The shunt migration had occurred after the first time insertion of the vp shunt.The symptoms at the time of presentation of the migration were vomiting and protruded shunt from the mouth.The patient showed normal ventricular size in the radiological workup.The distal end was removed from the oral route (cutting the distal end at the scalp incision distal to the reservoir) and the csf was also externally diverted for 1 week to exclude any inflammation and then a vp shunt was reinserted.A 7 month old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was the upper lumbar extrusion.The distal end had been inserted using a trocar.The shunt migration had occurred after 1 revision.The symptoms at the time of presentation of the migration were vomiting and extruded shunt from the upper lumbar region.The patient showed ventriculomegaly in the radiological workup.The shunt was removed from the back and the csf was externally diverted for a week and the vp shunt was reinserted.An 8 year old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was through the penis.The distal end had been inserted by a laparotomy.The shunt migration had occurred after the first time insertion of the vp shunt the follow-up for this patient was lost.A 9 year old male presented with a shunt migration of the distal catheter of their vp shunt.The site of the migration was from the umbilicus with csf leak.The distal end had been inserted by a laparotomy.The shunt migration had occurred after the first time insertion of the vp shunt.The follow-up for this patient was lost.

• Brand Name: UNKNOWN CATHETER
• 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: 7862017
• MDR Text Key: 119788223
• Report Number: 2021898-2018-00438
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention