MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Model Number 828814PL

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 04/28/2022

Event Type  Injury  

Event Description

This is 2 of 4 reports linked to mfg report numbers: 3013886523-2022-00208, 3013886523-2022-00215 and 3013886523-2022-00216.A physician reported a certas valve (id 828814pl) was implanted in the right side of a (b)(6) patient on (b)(6) 2022.The initial settings were fine when the physician took over the care, however, ventricle later collapsed.Then another certas valve (id 828814pl) was implanted in the left side on (b)(6) 2022, however, the valve was not performing as it should.Therefore, both valves were explanted on unknown date.On (b)(6) 2022 two additional certas valve (id 828814pl) were implanted which also not up to performance.Based on information provided, the patient is not doing well.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

The certas valve (id 828814pl) was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is due to a biological debris and protein build up interfering with the valve mechanism.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: CRTS SM IL SG VLV ONLY
• Type of Device: CERTAS PLUS SMALL & RA W/SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14492697
• MDR Text Key: 292610263
• Report Number: 3013886523-2022-00209
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780529378
• UDI-Public: (01)10381780529378(17)260228(10)5321621
• Combination Product (y/n): N
• PMA/PMN Number: K182265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 828814PL
• Device Catalogue Number: 828814PL
• Device Lot Number: 5321621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Date Device Manufactured: 03/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 YR