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 Problem Atrial Fibrillation (1729)

Event Date 12/01/2019

Event Type  Injury  

Event Description

The article, "does high dose statin pretreatment affect global strains in patients undergoing valve replacement", was reviewed.The article presented a retrospective, single center study on the effect of rosuvastatin 40 mg (initiated 7 days prior to surgery) in patients undergoing valve replacement (vr) for rheumatic mitral valve disease on left ventricular (lv) strain and biomarker release kinetics.Devices included an unknown abbott mechanical heart valve (both mitral and aortic).The article concluded that pre-operative high dose rosuvastatin was â¿¿cardioprotectiveâ¿¿ with favorable effect on lv global strain and release kinetics of biomarkers.These cut-offs (described for the first time for rheumatic valve replacement (vr)) can be used as prognostic predictors.[the primary and corresponding author was aditya kapoor, department of cardiology, sanjay gandhi pgims, lucknow 226014, india, with corresponding email: akapoor65@gmail.Com] the time frame of the study was from december 2019 to december 2021.A total of 50 patients were included, of which all received an abbott device.The average age was 40.9 years and the average gender was female.Comorbidities included diabetes mellitus, hypertension, smoking, atrial fibrillation.

Manufacturer Narrative

Summarized patient outcomes/complications of mhv - standard (mechanical heart valve) were reported in a research article in a subject population with multiple co-morbidities including diabetes mellitus, hypertension, smoking, and atrial fibrillation.Some of the peri- and post-procedural complications reported were atrial fibrillation, unexpected medical intervention; these complications are anticipated for the procedure and subject population.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 information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Literature: article title "does high dose statin pretreatment affect global strains in patients undergoing valve replacement.".

• 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: 18584039
• MDR Text Key: 333772745
• Report Number: 2135147-2024-00365
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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: 01/03/2024
• 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