MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Obstruction of Flow (2423)

Patient Problems Fever (1858); Headache (1880)

Event Date 08/12/2021

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

1 of 3 reports.Other mfg report numbers: 3013886523-2021-00380 and 3013886523-2021-00381.A physician reported a suspected shunt obstruction and infection of a codman certas plus programmable in-line valve.The valve was implanted in a (b)(6) male patient with a cerebral stroke via ventricular peritoneal shunt on (b)(6) 2021 with an initial setting of 3.The valve was used with 823045 (serial; unk) and ns9001(serial; unk).On (b)(6) 2021 the patient presented with a headache.The valve reservoir was pumped due to suspicion of obstruction, but the reservoir did not return immediately.On (b)(6) 2021 the patient had a fever.As a result of draining the cerebrospinal fluid from the reservoir and examining it, infection was found.The type of infection/organism and what laboratory tests were done to confirm the infection were unknown.It is unknown if the patient was administered medications for the suspected infection.The patient was taken to surgery on (b)(6) 2021 and the shunt system was removed.The patient is scheduled to go back to the operating room on once their condition is stable to re-implant a certas valve.The patient is in follow up.No further information was provided by hospital.

Manufacturer Narrative

The certas valve was returned for evaluation.Failure analysis - the catheters were visually inspected and no defect was noted.The catheters were flushed and no occlusion was noted.The catheters were leak tested; no leakage was noted.The valve was visually inspected and some biological debris were noted inside the valve as well as needle holes were noted in the needle chamber.The position of the cam when valve was received was at setting 1.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, anti-reflux, siphon guard and pressure.The valve was functioning.The complaint was not confirmed.No root cause could be determined as the technician could not confirm any problem with the valve and catheters at the time of investigation.The possible root cause for the issue "suspicion of obstruction" reported by the customer could have been due to 'biological debris and protein build up' interfering with the valve mechanism.The possible root cause for the "infection" reported by the customer could have been due to 'insufficient packaging materials and/or design' and/or 'biological debris'.But at the time of investigation no occlusion or reflux issues were noted.As specified in the ifu, at the 'precautions' section: "inspect the sterile package carefully.Do not use if: -the package or seal appears damaged, -contents appear damaged, or -the expiry date has passed.Use sterile technique in all phases of handling the valves and accessories".And, as specified in 'adverse events' section: "devices for shunting csf might need 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.Complications of implanted shunt systems include mechanical failure, shunt pathway obstruction, infection, foreign body (allergic) reaction to implants, and csf leakage along the implanted shunt pathway.Clinical signs such as headache, irritability, vomiting, drowsiness, or mental deterioration might be signs of a nonfunctioning shunt.Low-grade colonization, usually with staph.Epidermidis, can cause, after an interval from a few days to several years, recurrent fevers, anemia, splenomegaly, and eventually, shunt nephritis or pulmonary hypertension.An infected shunt system might show redness, tenderness, or erosion along the shunt pathway".

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 12408859
• MDR Text Key: 269409027
• Report Number: 3013886523-2021-00379
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR