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

Model Number 23AJ-501

Device Problems Perivalvular Leak (1457); Biocompatibility (2886)

Patient Problems Hemolytic Anemia (2279); Valvular Insufficiency/ Regurgitation (4449)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

The article, "a case of persistent hemolytic anemia and enlargement of valsalva sinus aneurysm after three open heart surgeries, on which aortic root replacement was performed", was reviewed.The research article presents a case study of a (b)(6) year old man who had ventricular septal defect (vsd) surgery at the age of three and aortic valve replacement (avr) for aortic regurgitation (ar) at the age of (b)(6).The patient experienced postoperative paravalvular leak (pvl) at the age of (b)(6) and a re-aortic valve replacement (manouguian method with a 23mm sjm mechanical heart valve) with annulus enlargement was performed by the previous doctor.After that, hemolytic anemia continued, and the patient was referred to our department.At the first visit, blood test indicated hb 13.1mg/dl, ldh 1540 u/l, tte/tee with ef61%, and there was a pannus-like structure extending from the anterior valve seat from which pvl was confirmed.Intraoperative findings showed a gap between the pannus-like hard structure observed by echocardiography and the valve seat, which was considered to be the main seat of pvl.In addition, the wall of valsalva sinus was partially thinned and protruded into the pulmonary artery (pa) like a sac, so it was closed.Bentall surgery was performed with gelweave valsalva graft 28 mm and 23 mm sjm mechanical heart valve.The postoperative course was uneventful, and echocardiography showed no pvl, and the patient was transferred to a local hospital at (post-operative day 15) pod15.

Manufacturer Narrative

Corrected h6.Medical device code 2886 - biocompatibility no longer applies additional information for: g3, g6, h2, h6, and h10 as reported in a research article, a patient was implanted with a 23mm sjm mechanical heart valve; an event of hemolytic anemia, paravalvular leak, pannus, thinned wall of valsalva sinus, and valve explant was 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.

• 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
• MDR Report Key: 11566599
• MDR Text Key: 242179537
• Report Number: 2648612-2021-00030
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23AJ-501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR