MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG; CHPV WITH SG

Catalog Number 823832

Device Problem Break (1069)

Patient Problem Dizziness (2194)

Event Date 02/07/2024

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 hakim valve (b)(6) was implanted on (b)(6) 2023.Several weeks later, patient felt dizzy.It was found that the valve was broken during a computed tomography (ct) scan check.Therefore, a physician conducted a revision procedure, and the valve was explanted and replaced with a new hakim valve (b)(6) 2024.The physician retrieved all the broken parts by removing fragments and an x-ray was taken to assure that no parts were left in patient.The patient is currently stable.

• Brand Name: PROG VALVE INLINE W SG
• Type of Device: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18842095
• MDR Text Key: 336958528
• Report Number: 3013886523-2024-00063
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K053107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 823832
• Date Manufacturer Received: 02/21/2024
• 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: 21 YR
• Patient Sex: Female