MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ SG

Catalog Number 828804PL

Device Problem Fracture (1260)

Patient Problem Headache (1880)

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 facility reported a fractured shunt between the siphon guard and the valve that was identified post patient implantation.A certas plus programmable valve was implanted via a ventricular peritoneal shunt on (b)(6), 2021.The procedure was a proximal catheter/valve exchange with an initial setting of 5.The patient re-presented on (b)(6), 2021 with complaints of worsening headache for 1 day, that was intermittently worse when sitting up.The shunt valve was explanted on (b)(6), 2021.No information was available on how the fracture between the siphon guard and the valve was identified.The patient was discharged home on (b)(6), 2021.The patient was evaluated in the clinic on (b)(6), 2021 for their post-operative visit and was reportedly still having headaches.The certas valve setting was changed to 3.The patient was re-evaluated for headaches on (b)(6), 2021 for headaches that were low pressure in nature.The headache was relieved when the patient was laying down.The certas valve setting was changed to 4 with the thought of possible over drainage at the setting of 3.No further information was provided.

Manufacturer Narrative

The certas valve was not returned for evaluation and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.However, the possible root cause for "fractured between the siphon guard and the valve" could be due to ¿housing is flexed during implantation" (wrong handling).As specified in the ifu, at the section 'surgical procedure precautions': "do not fold or bend the valve during insertion.Folding or bending might cause rupture of the silicone housing".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.

Event Description

N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• 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: 11917957
• MDR Text Key: 256730369
• Report Number: 3013886523-2021-00240
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804PL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1