MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT; CERTAS PLUS W/ SG

Catalog Number 828806

Device Problem Obstruction of Flow (2423)

Patient Problems Headache (1880); Nausea (1970)

Event Date 09/13/2021

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

A physician reported a certas plus valve was implanted in a patient via l-p shunt on (b)(6) 2021, with setting 5.The valve was used with the silascon lumbar catheter (manufactured by (b)(4), product code: 702-jj).The patient is being treated for breast cancer.Due to the symptoms of increased intracranial pressure due to cancerous meningitis, lp shunt surgery was performed.After placement, low marrow pressure-like symptoms continued, and the set pressure was changed to 6 on (b)(6) 2021.After the change, the symptoms improved, and patient was discharged from the hospital on the (b)(6).The patient visited the hospital on (b)(6) 2021 with headache and vomiting.The intracranial pressure was measured and was 10 mmh2o, which was set to 7.Mri was performed on (b)(6) 2021.Patient had symptoms of headache and nausea again, and when the intracranial pressure was measured, it was 30 mmh2o and the patient was hospitalized on the same day.Shunt contrast was performed (b)(6) 2021.The proximal catheter did not appear to be occluded, but there was no influx of contrast into the distal catheter by pumping.The valve was explanted and replaced on (b)(6) 2021.The next day, (b)(6) 2021, the symptoms improved.On (b)(6) 2021, the intracranial pressure increased again, and it is being adjusted.The patient is in the follow-up.

Manufacturer Narrative

The certas valve (id 828806) was returned for evaluation.Failure analysis - the valve was visually inspected; the needle guard was raised, and some needle holes were noted in the needle chamber.The valve was hydrated.The catheter was irrigated no occlusions noted.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.The root cause for ¿the certas body or distal catheter was suspected to be obstructed.¿ could be due to biological debris and protein build up interfering with the valve mechanism, at the time of investigation no occlusion issues were noted.The root cause for the raised needle guard noted during the investigation is probably due to wrong handling as noted in the ifu: do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard disc dislodgement or occlusion of the fluid pathway, at the time of the investigation no occlusion issues were noted.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12545641
• MDR Text Key: 273735851
• Report Number: 3013886523-2021-00415
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 44 YR
• Patient Sex: Female