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

Model Number	27MTJ-503
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Cardiac Perforation (2513)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of a ruptured left ventricle was reported.The results of the investigation are inconclusive since the device was discarded by the hospital and therefore was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field states that "the surgeon assumed that due to over sizing of this valve against the patient's mitral annulus, the patient's myocardium was likely perforated/torn by the pivot guard of this valve, which resulted in rupture of left ventricle.A smaller, 25mm, valve was subsequently implanted.
Event or Problem Description
On (b)(6) 2018, a mitral valve replacement (mvr) was performed and this 27mm masters series heart valve was implanted.Concomitantly, a tricuspid annuloplasty (tap) and maze procedure were performed.When returning to spontaneous circulation, the patient's left ventricle ruptured.The ruptured area of the left ventricle was repaired and this valve was explanted and replaced with a smaller 25mm masters series heart valve.The patient has been in stable condition postoperatively.The surgeon assumed that due to over sizing of this valve against the patient's mitral annulus, the patient's myocardium was likely perforated/torn by the pivot guard of this valve, which resulted in rupture of left ventricle.This valve was discarded in the hospital and will no longer be returned for analysis.No additional information is expected.

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 7908238
• Report Number: 2648612-2018-00084
• Device Sequence Number: 1653868
• Product Code: LWQ
• UDI-Device Identifier: 05414734053624
• UDI-Public: 05414734053624
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: 27MTJ-503
• Device Catalogue Number: 27MTJ-503
• Device Lot Number: 6070688
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR