MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number 823100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Macular Edema (1822); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

Journal of no shinkei geka, 48(7):633-640, 2020 published: ¿a rare case of communicating hydrocephalus with intraparenchymal pericatheter cyst and surrounding edema in an adult due to accidental change in the pressure setting of the programmable shunt system.¿ "a (b)(6)-year-old woman suffering from memory impairment visited our hospital.She was discharged nine years ago without complications after undergoing neck clipping surgery for intracranial aneurysm rupture and a right ventricular peritoneal shunt using the codman hakim programmable valve system (chpv) for hydrocephalus.Initial ct/mri revealed a cystic lesion with surrounding edema in the right frontal lobe around the proximal catheter, and a left frontal subacute subdural hematoma.The right ventricle was shown as a slit as before.The cystic portion presented with an mri signal of the same intensity as the cerebrospinal fluid(csf), and no enhancement effect was observed.It was thought to be a csf cyst around the shunt catheter with interstitial csf edema.Skull radiographs showed an accidental change in the chpv pressure setting (100 to 190mmh2o), possibly due to head impact.We concluded that the newly set valve pressure caused sudden shunt dysfunction, resulting in csf cyst formation and surrounding edema.Image findings and her symptoms were immediately improved on adjusting the shunt valve.This complication in adults associated with shunt dysfunction is very rare and only 10 cases have been reported to date.This is the first report of this complication due to an accidental reset of chpv.To prevent the risk of misdiagnosing this condition as a tumor or abscess and performing unnecessary surgery, it is always necessary to suspect the possibility of this complication.For that purpose, detailed images, including diffusion-weighted images and contrast-enhanced mri, should be done early in clinical practice.".

Manufacturer Narrative

The hakim valve was not returned for evaluation (literature study) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.Unique device identifier (udi) : (b)(4).

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10731505
• MDR Text Key: 212993611
• Report Number: 3013886523-2020-00169
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR