MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN CERTAS PLUS VALVE

Catalog Number XXX-CERTAS PLUS VALVE

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

Patient Problem Pneumothorax (2012)

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

It was reported pneumothorax on a patient with a certas valve implanted as part of a clinical trial.Additional information has been requested.

Manufacturer Narrative

The 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.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.Additional information received form the clinical study investigation site: ¿pi (principal investigator) confirmed that it was not possible that the pneumothorax was caused by the certas.To clarify: according to the pi this ae is not causal related to the device.It may be related to the procedure.The pi will check the patient files and look into other details of the ae including medication and resolution.¿.

Event Description

N/a.

• Brand Name: UNKNOWN CERTAS PLUS VALVE
• Type of Device: CERTAS PLUS
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11073259
• MDR Text Key: 223730610
• Report Number: 3013886523-2020-00267
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-CERTAS PLUS VALVE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1