MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Catalog Number 23AGFN-756

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

Patient Problem Unspecified Infection (1930)

Event Date 07/04/2023

Event Type  Injury  

Event Description

Crd_1036 - regent china pmcf cn5812 - 342 ((b)(4)).It was reported that on (b)(6) 2023, a 23mm sjm regent mechanical heart valve was implanted in a patient.On (b)(6) 2023, it was reported that the patient had infection of incisional wound and was hospitalized on the same day.There was an open incision about 3cm on the sternal surgery area with niff.The pus burst out after a hard squeeze on the previous surgical drainage area.Elective debridement treatment is planned on an unknown date.Between july 05-09 2023, the wound dressing was changed daily.The incision healed well and the patient was discharged on (b)(6) 2023.The patient is stable, the device is working as intended.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.

Manufacturer Narrative

An event of infection of incisional wound was reported.The wound dressing was changed daily and the incision healed.A returned device assessment and histopathological examination could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17414100
• MDR Text Key: 320039195
• Report Number: 2135147-2023-03301
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006095
• UDI-Public: 05414734006095
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 23AGFN-756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 85 KG