MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 21AJ-501

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

Patient Problems Dyspnea (1816); Hemoptysis (1887); Pleural Effusion (2010); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a (b)(6) year old patient underwent a redo-sternotomy and aortic valve replacement with a 21mm sjm masters series mechanical heart valve.Events of a hemoptysis, shortness of breath, pneumonia, drop in hemoglobin, pseudoaneurysm, pleural effusion, bleeding, and parenchymal erosion were reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, "unusual presentation of aspergillus aortitis after aortic valve surgery with massive haemoptysis ", was reviewed.This research article reported a case study on a (b)(6) year old male with a history of hyperlipidemia who underwent a redo-sternotomy and aortic valve replacement using a 21mm sjm mechanical valve.At the 6 week follow up the patient complained of cough with blood.The patient's warfarin was titrated since the patient's inr was at 3.Despite normalized inr, the patient's hemoptysis persisted and the patient presented again with decreased effort tolerance and shortness of breath and was diagnosed with right lower lobe pneumonia.The next day, the patient's hemoglobin dropped and inr increased.The patient underwent urgent computed tomography (ct) of the chest which revealed a 12.4 x 10.3 cm ascending aorta pseudoaneurysm compressing the right lung.There was a moderate sized right pleural effusion with ground-glass changes in the middle and lower lobes.The patient was transferred to the intensive care unit immediately and warfarin reversed before undergoing emergency surgery.The patient underwent redo-sternotomy under circulatory arrest.The ascending aorta pseudoaneurysm was found ruptured above the aortotomy suture line for at least half of the aortic diameter.The mechanical valve was examined and found well sited.An ascending aorta was replaced with a size 26mm straight gelweave graft.There was profuse bleeding from the right lung caused by direct parenchymal erosion from the pressurized pseudoaneurysm that was repaired.Intra-operative culture of aortic wall tissue grew aspergillus fumigatus.Post-operatively, the patient¿s cardio-respiratory function recovered.This event is conservatively being reported.The article concluded that invasive aspergillus infection of the aorta is a rare and aggressive complication with high mortality.Early identification is the only way to improve patient survival.The primary author of this article is lowell leow, mbbs, mrcs, department of cardiac, thoracic and vascular surgery, national university hospital, national university health system, singapore.The correspondence author is qian qi, md, department of cardiac, thoracic and vascular surgery, national university hospital, national university health system, singapore, 1e kent ridge road, nuhs tower block, level 9, singapore 119228 with the corresponding email: qi_qian@nuhs.Edu.Sg.

• Brand Name: SJM MASTERS SERIES MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11372899
• MDR Text Key: 233316829
• Report Number: 2648612-2021-00013
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21AJ-501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2021
• 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: 51 YR