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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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

1 of 10 reports.Other mfg report numbers: 3013886523-2021-00481, 3013886523-2021-00482, 3013886523-2021-00483, 3013886523-2021-00484, 3013886523-2021-00485, 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 1 - adverse event - slit ventricles case report: a (b)(6) boy presented with a history of shunt placement for malresorptive hydrocephalus after posthemorrhagic hydrocephalus with disability and tetraspasticity.A medium pressure burr hole valve vp-shunt system was implanted in the first year after birth.It was changed to programmable codman hakim-medos valve at the age of (b)(6) because of overdrainage.The postoperative development of the child was regular.He remained developmentally delayed and wheelchair-dependent but was asymptomatic concerning the hydrocephalus and the shunt function remained intact.Three months before admission to the hospital, he was falling off his wheelchair at school.Since then, he is presenting with autoaggressive behavior and emesis, unfortunately without further shunt controls.The reservoir resulted in very slow refilling.The cranial computed tomography (ct) showed slit ventricles confirming the suspicion of overdrainage.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.Implantation of a new shunt valve (codman hakim-medos valve) was performed.Thereafter, 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, nevertheless a literature study and photos were provided:: failure analysis - this complaint concerns a literature study published in feb.2020 about patients admitted to the pediatric department between (b)(6) 2013 and (b)(6) 2018 and concerning 'programmable valve breakage in shunt systems of children after minor head trauma'.The study concluded that 'valve breakage is a very rare condition (4,3% - 5/85 implanted codman hakim-medos valve), often missed, and must be kept in mind when trauma and prior mri scan are reported'.Nevertheless, based on the information provided in the literature study ("the pressure control chamber could be seen dislocated in the inferior part of the reservoir in an illustration in the literature) therefore stator dislodgment could be confirmed that may have caused 'slit ventricles' and 'overdrainage' as reported.Root cause: the cause(s) of the difficulty reported by the customer could not be clearly determined.The possible root cause for ¿slit ventricles confirming the suspicion of overdrainage" reported by the customer in the literature study could be due to "insufficient material properties" ('galvanic corrosion' that may occur because of the age of the device and/or a 'hard knock' that may have permanently deformed mechanism).As stated in the literature case: 'three months before admission to the hospital, he was falling off his wheelchair at school.Since then, he is presenting with autoaggressive behavior and emesis, unfortunately without further shunt controls'.As stated in the risk benefit analysis document for hakim valves: "integrated shunt components could become dislodged over time or occur with trauma to the device [.].There are other potential causes of mechanical disruption, including shock or a potential thin base plate leading to an improper stator component press fit".As specified in the ifu, at the section 'adverse events': "devices for shunting csf may have to be replaced at any time due to medical reasons or failure of the device.Keep patients with implanted shunt systems under close observation for symptoms of shunt failure [.] excessive csf drainage can cause subdural hematomas, slit-like ventricles, and in infants, sunken fontanelles [.] blunt or sharp trauma to the head in the region of implant or repetitive manipulation of the valve during implant may compromise the shunt.Check valve position and integrity after occurrence".

• 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: 12800554
• MDR Text Key: 282967763
• Report Number: 3013886523-2021-00480
• 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: 12/16/2021

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?: Yes
• Is this a Product Problem Report?: No
• 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: 11/30/2021
• 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: 13 YR
• Patient Sex: Male