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

Model Number 29VAVGJ-515

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

Patient Problems Atrial Flutter (1730); Pleural Effusion (2010); Tachycardia (2095); Pericardial Effusion (3271); Syncope/Fainting (4411); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/30/2023

Event Type  Injury  

Event Description

Clinical information: (b)(4).Patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was implanted.On (b)(6) 2023, the patient presented to the emergency department complaining of syncope, shortness of breath, and palpitations.A newly onset atrial flutter with tachycardia was observed on ekg.Patient was admitted to the hospital.Patient's bnp was elevated.On ct scan, patient had new small left-sided pleural effusion and mild pericardial effusion seen.Mild cardiomegaly, trace right, and mild interstitial edema was also observed.Patient's symptoms were clinically consistent with newly onset heart failure.Patient was administered iv amiodarone and diltiazem.Patient was transferred to study site for further observation.

Manufacturer Narrative

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

Manufacturer Narrative

An event of syncope, shortness of breath, tachycardia palpitations, small left-sided pleural effusion, mild pericardial effusion, cardiomegaly, trace right, and mild interstitial edema 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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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.

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on 10 january 2023, a 29mm sjm masters series valsalva aortic valved graft was implanted.On 30 january 2023, the patient presented to the emergency department complaining of syncope, shortness of breath, and palpitations.A newly onset atrial flutter with tachycardia was observed on ekg.Patient was admitted to the hospital.Patient's bnp was elevated.On ct scan, patient had new small left-sided pleural effusion and mild pericardial effusion seen.Mild cardiomegaly, trace right, and mild interstitial edema was also observed.Patient's symptoms were clinically consistent with newly onset heart failure.Patient was administered iv amiodarone and diltiazem.Patient was transferred to study site for further observation.On 01 february 2023, on transthoracic echocardiogram (tte), the device had a normal appearance and function.There were no device issues or malfunction noted on the implanted 29mm sjm masters series valsalva aortic valved graft.

• 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: 16438570
• MDR Text Key: 310371358
• Report Number: 2135147-2023-00664
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 8802642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White