MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV ONLY; CERTAS PLUS

Catalog Number 828800

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 12/18/2020

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 the certas valve was implanted to a (b)(6) female via l-p shunt on the (b)(6) 2020 with an unknown setting.On next day, mri was performed to the patient.After mri, the patient said that she felt the valve was floated and rotated during mri.Then, when the x-ray was performed and confirmed, the valve was inverted.On (b)(6) 2020, a surgical procedure was performed to place the valve to the original position.The patient recovered.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).The certas valve was not returned for evaluation (product remains implanted) 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.

Event Description

N/a.

• Brand Name: CERTAS INLINE VLV ONLY
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11127894
• MDR Text Key: 225520674
• Report Number: 3013886523-2021-00006
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR