MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MECHANICAL HEART VALVE

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

Patient Problems Tachycardia (2095); Pseudoaneurysm (2605); Heart Block (4444)

Event Date 03/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The article abstract, "a case report of surgery for superior vena cava syndrome caused by ascending aortic aneurysm and pacemaker lead", was reviewed.The article presents a case study of a 70-year-old man with aortic regurgitation.It was reported on an unknown date 15 years ago, a 25mm sjm masters series mechanical heart valve was implanted.The patient subsequently underwent dual-chamber (ddd) pacemaker in the left anterior chest due to atrioventricular blockade.It was reported on an unknown date 3 years ago, the patient required a cardiac resynchronization therapy defibrillator (crtd) in the right anterior chest for ventricular tachycardia (vt).Later, it was reported on an unknown date 3 months ago, the patient presented with upper body and facial edema.A computed tomography (ct) revealed an area of contrast defect in the right internal jugular vein and subclavian vein confluence.It was reported that thrombus formation was suspected but it was also noted the patient had dilated peripheral internal jugular vein, distension of the azygos and jugular vein, and dilatation of the right precordial subcutaneous vein which led to diagnosis of superior vena cava syndrome.It was reported three-year-old ct showed dilation in the ascending aorta and sinus of valsalva, leading to new identification of a pseudoaneurysm in the ascending aorta.A decision was made to perform a bentall procedure and innominate vein bypass to treat superior vena cava syndrome.[the primary author was keisuke nakamura, showa university northern yokohama hospital, 35-1 chigasakichuo, tsuzuki ward, yokohama, kanagawa 224-0032, japan].Post-procedure complications: surgical intervention, heart block, tachycardia, edema, pseudoaneurysm.

Manufacturer Narrative

As reported through a literature review a patient with aortic regurgitation who had a mechanical heart valve implanted.Subsequently, the patient underwent dual-chamber (ddd) pacemaker in the left anterior chest due to atrioventricular blockade.Later, an unknown date, the patient presented with upper body and facial edema.It was reported that thrombus formation was suspected but it was also noted the patient had dilated peripheral internal jugular vein, distension of the azygos and jugular vein, and dilatation of the right precordial subcutaneous vein which led to diagnosis of superior vena cava syndrome.It was reported three-year-old ct showed dilation in the ascending aorta and sinus of valsalva, leading to new identification of a pseudoaneurysm in the ascending aorta.A decision was made to perform a bentall procedure and innominate vein bypass to treat superior vena cava syndrome.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Based on the available information, the root cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: UNKNOWN MECHANICAL HEART VALVE
• 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: 17399515
• MDR Text Key: 319837159
• Report Number: 2135147-2023-03211
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male