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

Catalog Number 25VAVGJ-515

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

Patient Problem Atrial Fibrillation (1729)

Event Date 06/28/2023

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 25mm sjm masters series valsalva aortic valved graft was selected for implant.It was noted during procedure that the aortic valved graft did not fit the anatomy of the patient and was not implanted.The patient had remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the implant procedure reported.The patient was stable and had a baseline normal sinus rhythm prior to procedure.On (b)(6) 2023, it was noted that the patient developed atrial fibrillation with rapid ventricular response with a heart rate of 120 beats per minute.The decision was made to administered the patient intravenous amiodarone.The patient was also started on an oral 400mg dose of amiodarone.On (b)(6) 2023, the patient was again administered intravenous amiodarone and a peripherally inserted central catheter was placed.On (b)(6) 2023, the patient's heart rate was a 140 beats per minute.The patient was administered intravenous amiodarone and put on an amiodarone drip.It was noted that prior to discharge the patient had received at total of 9 grams of amiodarone.The patient was discharged with an at home regimen of 200mg of amiodarone at the time of report.The cause of the patient's atrial fibrillation with rapid ventricular response is attributed to the cardiac surgery.

Manufacturer Narrative

An event of atrial fibrillation with rapid ventricular response was reported.It was also reported that during implant procedure aortic valved graft did not fit the anatomy of the patient and was not implanted.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that the cause of the patient's atrial fibrillation with rapid ventricular response is attributed to the cardiac surgery.

• 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: 17367594
• MDR Text Key: 319479351
• Report Number: 2135147-2023-03131
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25VAVGJ-515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• 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): Other; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Patient Race: White