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

Catalog Number 828806

Device Problem No Flow (2991)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that a certas valve was occluded and revised.The valve was implanted via lp due to idiopathic normal pressure hydrocephalus.The patient's condition worsen therefore an angiography was made.It was confirmed that the flow did not go to the distal and the valve was suspected of obstruction.A revision surgery was performed.The surgeon checked the flow of the valve after removal and it seemed that there was a sign of obstruction.The new valve was implanted via vp.The level of csf protein was within range.No permeation of blood or debris to the cerebrospinal fluid was confirmed.

Manufacturer Narrative

Udi: (b)(4).Complaint sample was not returned to codman 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.The cause(s) of the difficulty reported by the customer could not be determined.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.

• 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: 8596197
• MDR Text Key: 144590487
• Report Number: 1226348-2019-00141
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1