MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Model Number 27VAVGJ-515

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 03/30/2023

Event Type  Injury  

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id:(b)(6).It was reported that on 22 march 2023, a 27mm sjm masters series valsalva aortic valved graft was implanted for a history of primary valve disease and a 52mm aneurysm.A thoracic aorta repair was also performed during the same surgery.There were no intraprocedural adverse events or device deficiencies recorded.On 30 march 2023, there was suspicion of an infected retrosternal hematoma due to elevated white blood cell (wbc) count and elevated c-reactive protein (crp) test.This event was reported to be a procedural complication, and there was no allegation of malfunction against the implanted device.The patient was administered antibiotic ceftriaxone.The patient's hospitalization was prolonged.The patient status was reported as stable.

Manufacturer Narrative

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

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: eu3549 - 353, (b)(4).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was implanted for a history of primary valve disease and a 52mm aneurysm.A thoracic aorta repair was also performed during the same surgery.There were no intraprocedural adverse events or device deficiencies recorded.On (b)(6) 2023, there was suspicion of an infected retrosternal hematoma due to elevated white blood cell (wbc) count and elevated c-reactive protein (crp) test.This event was reported to be a procedural complication, and there was no allegation of malfunction against the implanted device.The patient was administered antibiotic ceftriaxone.The patient's hospitalization was prolonged.On (b)(6) 2023, there was pronounced scarring and inflammatory soft tissue formations in the left groin with air inclusions, which had a total diameter of 5cm, indicating an abscess.Patient was prescribed clindamycin.The patient status was reported as stable.

Manufacturer Narrative

An event of suspicion of an infected retrosternal hematoma due to elevated white blood cell (wbc) count and elevated c-reactive protein (crp) test was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated the reported event was likely due to procedural complications and that there was no allegation of malfunction against the abbott device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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 regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• 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: 16950313
• MDR Text Key: 315440638
• Report Number: 2135147-2023-02154
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 8488676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Race: White