MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-TISSUE VALVE

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

Patient Problems Non specific EKG/ECG Changes (1817); Renal Failure (2041)

Event Date 01/12/2020

Event Type  Injury  

Manufacturer Narrative

Citation: fukuhara s, brescia aa, shiomi s, et al.Surgical explantation of transcatheter aortic bioprostheses: results and clinical implications.J thorac cardiovasc surg.2021;162(2):539-547.E1.Doi:10.1016/j.Jtcvs.2019.11.139 earliest date of publication used for date of event.Medtronic surgical valve products referenced: freestyle (product code lwr, pma# p970031), mosaic (product code p990064, pma# dye).Earliest approved product used for product code and pma#.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature was reviewed regarding the results of surgical explantation of transcatheter aortic bioprostheses.Of the 17 patients included in the study population, 5 were previously implanted with a medtronic surgical aortic valve (freestyle = 4, mosaic = 1).All 5 patients underwent transcatheter valve-in-valve replacement.The reasons for valve-in-valve replacement were not specified.All 17 patients in the study had a transcatheter aortic valve surgically explanted and replaced with a surgical aortic valve.Of the explanted transcatheter valves, 13 were medtronic products (corevalve = 4, evolut r = 6, evolut pro = 3) and the remaining 4 were non-medtronic products (sapien = 1, sapien 3 = 3).Reasons for explant included: severe symptomatic paravalvular leak (7 cases), structural valve degeneration (4 cases), intra-operative conversion to surgery due to valve migration (2 cases), intra-operative conversion to surgery due to coronary obstruction with hemodynamic instability (2 cases), prosthetic valve endocarditis and resultant severe aortic inefficiency (1 case), and bridge-to-definitive open procedure (1 case).The median transcatheter valve age was 195 days (range, 69 to 486 days).Of note, the authors stated the oldest valve was a 29 mm corevalve, which was 6.5 years old.Other adverse effects and interventions were described as follows: severe mitral regurgitation due to valve migration with or without severe tricuspid regurgitation, ventricular septal defect, heart failure, stroke, endothelialization and calcification of the transcatheter valve, unplanned aortic root replacement, unplanned aortic patch repair with partial aortic root replacement of the noncoronary sin us segment due to near-totally disintegrated aortic wall from the valve explant, multiple tacking stitches required to repair the destroyed aortic wall from endarterectomy, need for extracorporeal membrane oxygenation support for 48 hours following valve explant due to cardiorespiratory failure, and need for intra-aortic balloon pump insertion.Of the 17 patients included in the study population, 6 had a permanent pacemaker implanted prior to surgical explantation of the transcatheter aortic valves.It is unknown if the previously implanted surgical or transcatheter valves were associated with the need for permanent pacemaker implantation.Following transcatheter valve explant, 2 patients were implanted with a medtronic freestyle surgical aortic valve and the remaining 15 patients received a non-medtronic valve (magna ease = 9, trifecta = 5, regent = 1).Post-operatively, the authors observed two in-hospital deaths.No evidence was presented to suggest that a medtronic valve or its function contributed to any of the deaths.Other post-operative outcomes included: new or worsening renal failure and need for permanent pacemaker implantation.No additional adverse effects were noted.

• Brand Name: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17455301
• MDR Text Key: 320376452
• Report Number: 2025587-2023-03197
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• 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; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male