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

Device Problems Backflow (1064); Obstruction of Flow (2423)

Patient Problems Aortic Valve Stenosis (1717); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 173 patients had their mechanical valve replaced due to aortic stenosis or regurgitation.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.

Event Description

The article, "redo-aortic valve replacement in prior stentless prosthetic aortic valves: transcatheter versus surgical approach", was reviewed.This research article is a retrospective single center experience to compare outcomes of redo-aortic valve replacement (avr) via surgical or transcatheter approach in prior surgical avr with large percentage of prior stentless surgical avr.Freestyle/corevalve/evolut r/evolut pro (medtronic), sjm mechanical (abbott), sapien/sapien xt/sapien s3 (edwards lifesciences) and other valves were associated with the study.The article concluded that although the valve in valve (viv) transcatheter aortic valve replacement (tavr) group were higher risk patients, there were significantly fewer procedural complications, shorter length of stay, and similar mortality outcomes up to 1-year follow-up in the overall patients as well as in the stentless group analysis.The primary author of the article is charles h.Choi md, section of cardiovascular medicine, wake forest school of medicine, wake forest baptist health system, winston-salem, north carolina, usa.The correspondence author of the article is david x.M.Zhao, section of cardiovascular medicine, wake forest school of medicine, wake forest baptist health system, 1 medical center boulevard, winston-salem, nc 27157, usa with the corresponding email: dazhao@wakehealth.Edu.

• 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 ; * 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12577411
• MDR Text Key: 274773232
• Report Number: 2648612-2021-00096
• 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
• Report Date: 10/05/2021

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/05/2021
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86