MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RESERVOIR UNITIZED

Catalog Number	823148
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/16/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that on (b)(6) 2024, a hakim programmable valve was implanted in a 85-year-old male patient.On (b)(6) 2024, the patient underwent exploratory surgery (the shunt was checked at peritoneal end as well as on ventricular end and was found blocked at ventricular end by the surgeon as he tried repeated flushing of device, but nothing came out) and as per the physician shunt was not functioning properly and during the surgery surgeon found that the shunt is blocked and on an unknown date, the patient's symptoms did not improved after valve implantation.On (b)(6) 2024, the valve was explanted and replaced.Company remarks: the causality for the reported events is considered not assessable due to lack of information.Regarding the events, concomitants, concurrent conditions, past medications and complete medical history.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information received: indication for use: hydrocephalus.This is a case regarding an 85-year-old elderly male patient who had shunt occlusion, shunt malfunction and device ineffective during the use of chpv shunt (codman hakim programmable valve) for hydrocephalus.No medical history was reported.The patient's concurrent condition included hydrocephalus.No family history was reported.Past medication was not reported.Concomitant medication and co-suspect medications were not reported.No drug allergies were reported.On 30-may-2024, the patient started using chpv shunt (id: 823148)(codman hakim programmable valve) (serial number: (b)(6)) (udi-di: (b)(4).At an unknown dose at an unknown frequency via an unknown route.The lot/ batch number was reported as 7249620 and expiry date was not reported."on (b)(6) 2024, the patient underwent exploratory surgery (the shunt was checked at peritoneal end as well as on ventricular end and was found blocked at ventricular end by the surgeon as he tried repeated flushing of device, but nothing came out) and as per the physician shunt was not functioning properly and during the surgery surgeon found that the shunt is blocked, and on an unknown date, the patient's symptoms before surgery remained same after the surgery no improvement was seen.Additionally, it was conveyed that the valve was defective even after the flushing, and the procedure was delayed due to pressure setting due to non-working programmer after surgery, not in shunt implantation." "on (b)(6) 2024, the explantation of the device was done and on same day replacement was performed and currently patient was implanted with another valve.The patient was impacted with other valve.Additionally, it was conveyed that the device is available for evaluation and currently the device is with surgeon.Additionally, it was informed that the signs and symptoms of patients before and after surgery were related to hydrocephalus (disease) and they remained unchanged." at the time of the reporting, the outcome of the event's shunt was not functioning properly (shunt malfunction), shunt is blocked (shunt occlusion) and no improvement was seen was unknown.Pertinent lab data included: unknown.The action taken with chpv shunt (codman hakim programmable valve) was unknown.Company remarks (sender's comments).This case was assessed as serious due to other medically condition and hospitalization.This case was verified by a health care professional.This is a serious case, regarding an 85-year-old elderly male patient who had shunt occlusion, shunt malfunction and device ineffective during the use of chpv shunt (codman hakim programmable valve) for hydrocephalus.The causality for the reported events are considered to be not assessable due to lack of information regarding co suspects, concomitants, past medications and complete medical history.Moreover, the confounding role of hydrocephalus and procedural compilations cannot be excluded.As per the company safety information, the reported events occlusion and shunt malfunction are labeled and device ineffective is unlabeled.
Additional Manufacturer Narrative
The hakim valve (id 823148) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined, however, a possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.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.
Additional Manufacturer Narrative
The hakim valve ((b)(4)) was not returned for evaluation, but a video was provided showing the explanted valve being flushed but with no flow.Device history record (dhr) - product code 82-3148 with lot 7249620, conformed to the specifications when released to stock.Root cause analysis - a possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the device.However, it was not possible to confirm and identify the root cause of this assumption as the product was not returned for investigation.
Event or Problem Description
N/a.

• Brand Name: CHPV RT ANG RESERVOIR UNITIZED
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19680495
• Report Number: 3013886523-2024-00197
• Device Sequence Number: 20546018
• Product Code: JXG
• UDI-Device Identifier: 10381780519225
• UDI-Public: (01)10381780519225(17)280430(10)7249620
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823148
• Device Lot Number: 7249620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 09/05/2024; 10/11/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/20/2024; 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Race: Asian