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

Catalog Number 828806

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cerebral Ventriculomeglia (2133)

Event Date 01/06/2021

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 shunt obstruction.A certas valve was implanted in a patient with hydrocephalus secondary to left thalamic bleeding via a ventricular peritoneal shunt on (b)(6) 2020 with an initial setting of 4.On (b)(6) 2020, the symptoms were reportedly better and ventricular reduction was confirmed by ct image.On (b)(6) 2021, ventricular enlargement was observed.The contrast agent was not confirmed from the distal side of ventricular catheter.But pumping could reportedly be conducted easily.The contrast agent was confirmed from the distal side of peritoneal catheter when slight pressure slight was applied.The physician reportedly judged that the valve was not obstructed completely, and the setting was changed to 2 from 4.On (b)(6) 2021, the size of ventricular enlargement was not changed.The patient was taken to the operating room for a valve replacement on (b)(6) 2021 with an initial setting of 4.During the procedure, the physician reported blood was observed inside the valve and catheter.

Manufacturer Narrative

The certas valve was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; biological debris was noted inside the valve as well as needle holes in the needle chamber and the needle guard was raised.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, refux and siphon guard.The valve failed the test for pressure.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was noted on the on the ruby ball and on the seat of ruby ball.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone housing base.The root cause for the raised needle guard is 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.The root cause for the reflux and pressure issue noted during the investigation is due to the biological debris found on the ruby ball and the seat of the ruby ball, the debris is stopping the ball from sitting correctly.The possible root cause for the issue reported by the customer was probably due to biological debris and protein buildup interfering with the valve mechanism, at the time of investigation no occlusion was 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
• MDR Report Key: 11219800
• MDR Text Key: 228418229
• Report Number: 3013886523-2021-00043
• 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
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

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: 828806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/23/2021
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR