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

Device Problems Obstruction of Flow (2423); Biocompatibility (2886)

Patient Problems Dyspnea (1816); Thrombus (2101); Transient Ischemic Attack (2109)

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 "surgical treatment of prosthetic mechanical valve thrombosis with the aid of high-flow co2" was reviewed.This research article reported a case study on a (b)(6)-year-old woman who was implanted with a 23mm abbott mechanical valve in 2012.8 years later, the patient presented to the hospital with worsening dyspnea and a recent suspicious episode of transient ischemic attack.The patient had a therapeutic international normalized ratio of 2.6 and echocardiography revealed a severe trans-prosthetic gradient (45mmhg medium) with evidence of reduced mobility at one of the prosthesis discs.Transoesophageal echocardiography confirmed blockage of one of the prosthesis discs, but no formations larger than 0.8 cm2 were identified.The physician elected to perform a redo valve surgery, aiming to spare the aortic prosthesis in order to reduce the operation time.Visible thrombi was removed with a nerve hook and a small pannus was also noted during the procedure.Perioperative trans-oesophageal echocardiography showed physiological movement of the elements of the prosthesis with no significant trans-prosthetic gradient.No neurological events were recorded.The remainder of the postoperative course was uneventful.The article concluded that debridement of valve prostheses with the assistance of high-flow co2 appears to be a safe, feasible and effective option for thrombus removal.The primary author of this article is marco moscarelli, department of cardiovascular surgery, gvm care & research with the email m.Moscarelli@imperial.Ac.Uk.

Manufacturer Narrative

Additional information for: g4, g7, h2, h6, and h10.As reported in a research article, a patient with a mechanical heart valve had worsening dyspnea and transient ischemic attack.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: 10900155
• MDR Text Key: 218194758
• Report Number: 2648612-2020-00121
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/08/2021

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: 10/27/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR