MAUDE Adverse Event Report: ST. JUDE MEDICAL, BRASIL LTDA EPIC STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446)

Event Date 10/21/2021

Event Type  Injury  

Event Description

Related manufacturing reference number: 3014918977-2021-00104, 2648612-2021-00108.The article, "surgical outcomes of minimally invasive aortic valve replacement via right mini-thoracotomy for hemodialysis patients", was reviewed.This research article is a retrospective single center experience to assess the surgical outcomes of minimally invasive aortic valve replacement (avr) via right mini-thoracotomy (miavr) in hemodialysis patients compared with those of conventional avr (cavr) via full sternotomy.Carpentier edwards perimount, carpentier-edwards magna ease, inspiris, medtronic mosaic, sorin crown prt, trifecta, epic, perceval, ats ap360 and sjm regent valves were associated with the study.The article concluded that surgical outcomes of miavr in hemodialysis patients were acceptable, with a low incidence of morbidity, reasonable lengths of hospital stay, and no mortality among the patients studied.The primary author of the article is yujiro ito, department of cardiovascular surgery, chiba-nishi general hospital, 107-1 kanegasaku, matsudo-shi, chiba 270-2251, japan.The correspondence author of the article is yoshitsugu nakamura, department of cardiovascular surgery, chiba-nishi general hospital, 107-1 kanegasaku, matsudo-shi, chiba 270-2251, japan with the corresponding email ystgnkmr@gmail.Com.

Manufacturer Narrative

The investigation results will be provided in the final report.

Manufacturer Narrative

As reported in a research article, 42 patients underwent isolated aortic valve replacement (avr) for severe aortic stenosis(as) between april 2007 and november 2020; 2 patients were implanted with an epic valve.Events of two cerebral infarction, three respiratory failure, one re-exploration for bleeding and three wound infection.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: EPIC STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12918389
• MDR Text Key: 282203499
• Report Number: 3001883144-2021-00147
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 12/10/2021
• 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: 74 YR
• Patient Sex: Male