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 Sepsis (2067); Heart Failure (2206)

Event Type  Death  

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: 2648612-2020-00132, 3001883144-2020-00117.The article, "benchmarking outcomes: reoperation for aortic valve patient prosthesis mismatch, annals of thoracic surgery", was reviewed.The research article is a retrospective single center experience to investigate the clinical and echocardiographic outcomes of patients who underwent re-operation for correction of symptomatic patient prosthesis mismatch(ppm) following prior aortic valve replacement.Freestyle ms valve (medtronic), regent mechanical valves (abbott), gelweave valsalva prosthesis were associated with the study.There is no allegation of malfunction of the abbott device.The article concluded that re-operative surgery for ppm is complex, but may be performed with good outcomes and low mortality in experienced centers.The primary and corresponding author of the article is brent keeling, md, division of cardiothoracic surgery, emory university atlanta, ga with the email brent.Keeling@emory.Edu.

Manufacturer Narrative

As reported in a research article, after mechanical heart valve implant three patients died, two from sepsis and one due to biventricular failure.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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10988122
• MDR Text Key: 220882183
• Report Number: 2648612-2020-00133
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 63 YR