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

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

Patient Problem Complete Heart Block (2627)

Event Date 07/19/2020

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, 638 patients were implanted with an epic stented tissue valve.The rates of permanent pacemaker implant at 30-day, after 30-day, and at 5-year were (b)(6) respectively.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

Reference manufacturer report number: 3008452825-2020-00497.The article "early and late pace-maker implantation after transcatheter and surgical aortic valve replacement" was reviewed.This research article is a retrospective multi-center experience to evaluate the incidence and predictors of early and late permanent pacemaker (ppm) implantation after transcatheter aortic valve replacement (tavr) and surgical aortic valve replacement (savr) and its impact on long-term mortality.Accurate neo, corevalve, engager, evolut r/pro, lotus, portico, sapien 3, sapien xt, aspire, biocor/epic, freedom solo, hancock ii, inspiris resilia, mitroflow/crown, mosaic, perimount magna ease, soprano, and trifecta were associated to the study.There is no allegation of malfunction of the abbott devices.The article concluded that although the risk of 30-day ppm implantation is higher after tavr compared to savr, late (>30 days) ppm implantation was comparable with these treatment methods.Ppm implantation within 30 days did not affect late survival.The primary author of the article is fausto biancari md, phd, heart and lung center, helsinki university hospital with the email: (b)(6).

• Brand Name: EPIC STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA); 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. (PAMPULHA); rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10577735
• MDR Text Key: 208296933
• Report Number: 3001883144-2020-00093
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• 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: 09/09/2020
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR