MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Arrhythmia (1721); Hematoma (1884); Unspecified Infection (1930); Pleural Effusion (2010); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 05/19/2018

Event Type  Injury  

Manufacturer Narrative

Citation: wijayarathne pm et al.Pulmonary allograft versus medtronic freestyle valve in surgical pulmonary valve replacement for adults following correction of tetralogy of fallot or its variants.World j pediatr congenit heart surg.2019 sep;10(5):543-551.Doi: 10.1177/2150135119859853.Presented at (b)(6) society of cardiology congress 2018; (b)(6); (b)(6) 2018.Earliest date of publish used for event date.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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of outcomes in patients with prior surgical correction for tetralogy of fallot or its variants who underwent pulmonary valve replacement (pvr) with a freestyle valve or a pulmonary allograft.All data were retrospectively collected from three centers between april 1993 and march 2017.The study population included 152 patients and was predominantly male with a mean age of 34 years.Of those, 94 were implanted with medtronic freestyle bioprosthetic valves in the pulmonary position and 2 were implanted valve-in-valve with medtronic melody transcatheter pulmonary valves.No serial numbers were provided.Among all patients, 3 deaths occurred at 7 months, 4 years, and 7 years post-implant.The causes of death included: sudden for an unknown reason, bleeding due to ruptured leg veins, and during the post-operative period following the patient¿s second pvr (freestyle valve was removed and replaced with a pulmonary allograft).Based on the available information, medtronic product was not directly associated with the deaths.Among all freestyle patients, reinterventions included: transcatheter pulmonary valve-in-valve implantation (2 cases observed at 3- and 7-years post-implant, respectively), and redo surgical pvr (1 case observed at 7 years post-implant).Additional adverse events that were reported: arrhythmias, bleeding/coagulopathy, pleural effusion, infection, post-pericardiotomy syndrome, pericarditis, hematoma, moderate-severe pulmonary regurgitation, moderate-severe pulmonary stenosis, and elevated peak/mean pulmonary gradients.Based on the available information, medtronic product was associated with the adverse events.Among both melody patients, adverse events included: redo pvr due to endocarditis that occurred at an unspecified time within one-year post-implant (1 case).Based on the available information, medtronic product may have been associated with the adverse event.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Additional information received from the physician/author stated that the duration from melody valve-in-valve implantation to the onset of endocarditis was two years and that medtronic product was not directly related to the observed adverse events.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.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 9793210
• MDR Text Key: 188317258
• Report Number: 2025587-2020-00681
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR