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

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hydrocephalus (3272)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

6 of 10 reports.Other mfg report numbers: 3013886523-2021-00480, 3013886523-2021-00481, 3013886523-2021-00482, 3013886523-2021-00483, 3013886523-2021-00484, 3013886523-2021-00486, 3013886523-2021-00487, 3013886523-2021-00488, 3013886523-2021-00489.Child's nervous system (2020) published: "programmable valve breakage in shunt systems of children with posthemorrhagic hydrocephalus after minor head trauma¿a case series" purpose: "we report five rare cases of programmable valve breakage (codman hakim-medos valve) in shunt systems of children with posthemorrhagic hydrocephalus.Only four similar studies have been published in the current literature." methods: "between 2013 and 2018, five children with posthemorrhagic hydrocephalus were admitted to the pediatric department.All patients had a history of slight blows to the head in a minor trauma and follow up mri scans.After initial clinical examination, cranial computed tomography (ct) and x-ray were conducted." results: "in all cases, pumping the reservoir resulted in very slow refilling.The cranial ct in one patient showed slit ventricles confirming the suspicion of overdrainage, the other cases a slight enhancement of the hydrocephalus.In lateral x-rays of the skull in comparison to the first x-ray control of the shunt valve, the pressure control chamber could be seen dislocated in the inferior part of the reservoir in all cases.Surgery revealed that the shunt valve was broken.The pressure control chamber had dropped to the bottom of the reservoir.After implantation of a new shunt valve, the symptoms resolved completely in all five children.Overall this complication occurred in 4.3% (5 of 85 implanted codman hakim-medos valve) of all children necessitating ventriculoperitoneal shunt implantation between january 2013 and december 2018." conclusion: "the well-accepted codman hakim-medos programmable valve is part of a tube-system, which is designed to offer the possibility of a reliable and precise treatment of hydrocephalus.Various mechanical and non-mechanical complications of shunt systems have been reported.Valve breakage is a very rare condition, often missed, and must be kept in mind when trauma and prior mri scan are reported." patient 3 - malfunction - pressure control chamber dislocated case report: a (b)(6) boy presented with a history of shunt placement for malresorptive hydrocephalus after posthemorrhagic hydrocephalus with aqueduct stenosis.A codman hakim-medos vp-shunt system was implanted in the first year after birth.The child presented with headaches, emesis, and neurologic deterioration since the day before.The parents reported about a minor head trauma after play around.Shortly before admission, annual mri routine check was conducted.The reservoir resulted in very slow refilling.The cranial computed tomography (ct) showed a slight enhancement of the hydrocephalus.In lateral x-rays of the skull in comparison to the first x-ray control of the shunt valve, the pressure control chamber could be seen dislocated in the inferior part of the reservoir.After revision surgery and implantation of a new shunt valve (codman hakim-medos valve), the symptoms resolved completely.Postoperative x-ray control showed the new valve with the pressure control chamber in correct position.Https://doi.Org/10.1007/s00381-020-04541-6.

Manufacturer Narrative

The hakim valve was not returned for evaluation and lot number information has not 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.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12800640
• MDR Text Key: 283513329
• Report Number: 3013886523-2021-00485
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Sex: Male