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

Model Number 21VAVGJ-515

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

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pericardial Effusion (3271)

Event Date 04/21/2023

Event Type  Injury  

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: (b)(6).It was reported that on (b)(6) 2023, a 21mm sjm masters series valsalva aortic valved graft was implanted.No concomitant cardiac procedures were performed during the same surgery.There were no intraprocedural adverse events or device deficiencies recorded.On 14 march 2023, a computed tomography (ct) scan was performed which revealed fluid and air inclusion in sternal, retrosternum, and aortic root.Patient had pericardial effusion, mediastinitis, retrosternal hematoma, and retrosternal infection.This was believed to be related to patient's history of a wound healing disorder.Patient was started on antibiotics.There was macroscopically suspected hematoma infection with contact to the graft, and no bacteria was isolated.There were no direct signs of a graft infection.Hospitalization was prolonged.On ct scan, the sternum appeared to be stable.On (b)(6) 2023, patient had resternotomy performed with pleural and pericardial drainage.During reopening, some sternal fractures were observed.On 04 april 2023, the patient was discharged from the hospital.On 21 april 2023, the patient returned with sternal instability and was re-hospitalized.It was reported that there was no allegation against the abbott device, and the implanted valved graft was still working as intended.

Manufacturer Narrative

An event of pericardial effusion, mediastinitis, retrosternal hematoma, and retrosternal infection was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the reported event was believed to be related to patient's history of a wound healing disorder.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the information received, the cause of the reported incident could not be conclusively determined but could be related to the patient's medical history.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: 16950401
• MDR Text Key: 315440693
• Report Number: 2135147-2023-02157
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009478
• UDI-Public: 05414734009478
• 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: 07/18/2023

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: 06/30/2023
• Device Model Number: 21VAVGJ-515
• Device Catalogue Number: 21VAVGJ-515
• Device Lot Number: 6951865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2019
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White