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

Model Number 17AGN-751

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Hemoptysis (1887); Pulmonary Valve Stenosis (2024); Respiratory Failure (2484)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, an infant was implanted with a 17mm masters valve; 4 months past procedure one of the valve leaflets was immobile and the patient presented with acute respiratory failure, hemoptysis, right pulmonary hemorrhage, and pulmonary vein stenosis.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 "transcatheter mechanical manipulation of obstructed prosthetic mitral valve in an infant" was reviewed.It was reported in the article that a (b)(6) month old patient was implanted with a 17mm mechanical valve.Four months post procedure, the patient presented with acute respiratory failure, hemoptysis, and right pulmonary hemorrhage due to pulmonary vein stenosis.It was found that the valve leaflet was immobile due to obstruction by adherent fibrinous and inflammatory material.A balloon angioplasty was performed for the pulmonary vein stenosis, and a catheter was used to apply gentle force repetitively on the immobile leaflet to push open the leaflet, leading to the return of normal leaflet excursion.A catheter was then placed in the left atrium for localized thrombolytic therapy.There were no complications during or immediately after the procedures.Echocardiography showed appropriate movement of the mechanical valve leaflet.The article concluded that percutaneous manipulation of obstructed prosthetic valves is feasible and may be considered in selective patients who have contraindications to surgery and systemic thrombolysis.The primary author of the article is yousef arar, md of department of pediatrics, division of pediatric cardiology, university of texas southwestern medical center.The corresponding author is surendranath veeram reddy, md of department of pediatrics, division of pediatric cardiology, university of texas southwestern medical center with the email:suren.Reddy@utsouthwestern.Edu.

• Brand Name: SJM REGENT 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 ; RQ 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10853930
• MDR Text Key: 216679167
• Report Number: 2648612-2020-00122
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17AGN-751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 MO