MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR NOVUS VALVE, MEDIUM PRESSURE; SHUNTS

Catalog Number XXX- NOVUS VALVE

Device Problem Product Quality Problem (1506)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Breast Neoplasm (2438)

Event Type  Injury  

Manufacturer Narrative

The device is not expected to be returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.(b)(4).Linked to mfg report numbers: 2648988-2019-00004 and 2648988-2019-00006.

Event Description

Intracranial pressure and brain monitoring xiv published (2012) "idiopahic normal pressure hyrdocephalus : results of prospective cohort of 236 shunted patients." aim : to describe the outcomes and complication rates in 236 patients with idiopathic normal pressure hydrocephalus(inph) after treatment.Patients and methods: between march 1998 and june 2007, 257 consecutive patients with suspected inph syndrome were evaluated in the department of neurosurgery at a university hospital.Among a cohort of 257 patients with suspected inph, 244 were shunted and 236 were followed up at 6 months after shunting (145 men [61.4%] and 91 women [38.6%] with a median age of 75 years).The study protocol of these patients included clinical, radiological, neuropsychological and functional assessment.The decision to shunt patients was based on continuous intracranial pressure monitoring and csf dynamics studies.A differential low-pressure valve system, always combined with a gravity compensating device, was implanted in 99% of the patients.Differential low-pressure valve system was implanted and combined with a gravity compensating device in 233 of the 236 patients.In the remaining three patients, a medium pressure valve with an antisiphon device was implanted.The types of valve used in the present series were programmable hakim medos valve (medos s.A.) + low-pressure gravity compensating accessory (gca) (nmt neurosciences implants), delta valve (performance level of 0.5) with antisiphon device (medtronic ps medical), ventriculo-peritoneal catheter with a low-pressure gca (nmt neurosciences implants), dual swith mietke (braun-aesculap), hakim medos valves (nmt neurosciences implants), low-pressure novus valve with an antisiphon (integra), and medium-pressure novus valve with an antisiphon (integra).Results: early postsurgical complications were found in 13 of the 243 shunted patients (four (4) subdural hematoma, two (2) shunt malfunctions, four (4) systemic complications, one (1) postural hypoacusia, one (1) parenchymal hematoma, one (1) hemorrhagic complication when the burr hole was performed).Six months after shunting, the follow- up ct showed asymptomatic subdural collections (hygromas) in 8 of the 236 patients who remained under follow-up.None of these patients required treatment.Of the 236 patients, post-surgical complications were found in 7, consisting of 6 subdural hematomas (3 acute and 3 chronic) and a distal catheter infection.No shunt malfunctions were observed in this period.Conclusion: a high percentage of patients with inph can improve after shunting, with early and late complication rates of less than 12%.

Event Description

N/a.

Manufacturer Narrative

No complaint unit will be returned since this complaint corresponds to a retrospective review from march 1998 and june 2007.Based on the absence of lot and catalog information of the products used, it is not possible to identify the manufacturing time frame to be reviewed and, therefore, it was not possible to perform the dhr review and neither event/nc, capa, scar histories review.No failure analysis is possible.The reported condition is unconfirmed.The root cause is undetermined.

• Brand Name: NOVUS VALVE, MEDIUM PRESSURE
• Type of Device: SHUNTS
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• MDR Report Key: 8232191
• MDR Text Key: 132567572
• Report Number: 2648988-2019-00005
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K961859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX- NOVUS VALVE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/09/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1