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

Model Number 23VAVGJ-515

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/03/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Crd_992 - valved grafts pas.Pl5215 - 127 (b)(6) it was reported that on (b)(6) 2022, a 23mm masters mechanical heart valve was successfully implanted.On (b)(6) 2022, transthoracic echocardiogram (tte) showed pericardial tamponade which was treated with tamponade decompression with surgical intervention.After the pericardial tamponade was drained patient received heparin until discharge on (b)(6) 2022, the patient had c-reactive protein and leukocytosis elevation.Antibiotics were administered/adjusted.The patient was reported to be in stable condition.

Event Description

Crd_992 - valved grafts pas.Pl5215 - 127 (r740299301, r740305701).It was reported that on (b)(6) 2022, a 23mm masters mechanical heart valve was successfully implanted.On (b)(6) 2022, transthoracic echocardiogram (tte) showed high amount of fluid in pericardium around the whole heart.Hematoma behind the right ventricle which was pericardial tamponade and treated with tamponade decompression with surgical intervention.After the pericardial tamponade was drained patient received heparin until discharge on (b)(6) 2022, the patient had c-reactive protein and leukocytosis elevation.Antibiotics were administered/adjusted.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of hematoma resulting in pericardial tamponade was reported.A returned device assessment 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.

• 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: 16558621
• MDR Text Key: 311478123
• Report Number: 2135147-2023-01223
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 68 KG