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

Model Number 25VAVGJ-515

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

Patient Problems Stroke/CVA (1770); Ventricular Fibrillation (2130)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Crd_992 - valved grafts pas, pl5012 - 193 (r733453901, r733449301).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was selected for an implant due to the patient having multiple ventricular fibrillation defibrillations.Based on the image of the heart and electrical activity, a coronary artery bypass surgery (cabg) was performed.On (b)(6) 2023, it was reported that the patient began showing stroke symptoms.On (b)(6) 2022, the patients left upper limb was weaker, paresis-head computer tomography was performed.In the area of the posterior branch of the right internal capsule and the right thalamus, a hypoechoic area with discrete modeling of the third ventricle - ischemic change in the acute phase of stroke was observed.The patient was treated with amantadyna intravenously.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of ventricular fibrillation and stroke was reported.Field indicated that the patients left upper limb was weaker and the medical history included patient was an former smoker.The patients complications may have contributed to the reported event.Field also noted that there were no device related issues and worked as intented.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.

• 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: 16342213
• MDR Text Key: 309262192
• Report Number: 2135147-2023-00453
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8627104
• 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: 08/21/2022
• 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): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White