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

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

Patient Problems Hemoptysis (1887); Hemorrhage/Bleeding (1888); Hemorrhagic Stroke (4417); Ischemia Stroke (4418)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturing reference number: 2648612-2021-00044.The article, "prosthesis selection for aortic valve replacement with concomitant coronary artery bypass graft", was reviewed.This research article is a retrospective multi center experience to investigate postoperative outcomes in patients with a bioprosthetic or mechanical prosthesis.Sjm mechanical prosthetic valves(abbott), ats medical and hancock ii(medtronic) were associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that long-term survival, overall reoperation, or stroke incidence was comparable among the two groups, while patients with a mechanical valve showed a greater likelihood of major bleeding events.The primary author of the article is xingjian hu, department of cardiovascular surgery, union hospital, tongji medical college, huazhong university of science and technology, wuhan, china.The corresponding author of the article is yin wang, m.D., ph.D., department of cardiovascular surgery, union hospital, tongji medical college, huazhong university of science and technology jiefang avenue 1277#, wuhan, hubei, 430000, china with the corresponding email: wangyin0817@hotmail.Com.

Manufacturer Narrative

As reported in a research article, 4,478 patients underwent aortic valve replacement with concomitant coronary artery bypass graft between (b)(6) 2002 and (b)(6) 2018.1,952 of those patients were implanted with a mechanical prosthetic aortic valve and 533 patients were implanted with a bioprosthetic aortic valve.Sjm mechanical prosthetic valves (abbott), ats medical, and hancock ii (medtronic) were associated with the study.Events of 20 gastrointestinal bleeds, 12 intracerebral bleeds, 7 hemoptysis, 5 hemorrhagic strokes, 13 ischemic strokes, 6 reoperations due to prosthesis failure or dysfunction, and 16 reoperations due to coronary heart disease 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.

• Brand Name: SJM 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: 11697961
• MDR Text Key: 246430362
• Report Number: 2648612-2021-00040
• 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: 06/14/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR