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

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Renal Failure (2041)

Event Date 07/23/2022

Event Type  Injury  

Event Description

Medtronic received information from a literature article regarding macroscopic and microscopic features of surgically explanted tran scatheter aortic valves (tav).Pre-operative and surgical characteristics of patients undergoing surgical explant of tav at a single center were retrospectively analyzed from may 2007 to november 2020.A total of 21 patients who underwent surgical tav explant and subsequent surgical aortic valve replacement (savr) were included in the study population.Of these patients, 6 had a medtronic self-expandable tav (corevalve = 4, evolut r = 2) surgically explanted and replaced.During surgical tav explant and subsequent savr, one patient was implanted with a medtronic freestyle bioprosthesis.No unique device identifier numbers were provided.Among all 21 patients, the following clinical symptoms were observed at the time of surgical tav explant: heart failure, significant aortic insufficiency, decreased left ventricular ejection fraction, and elevated mean/maximum aortic valve gradients.Indications for tav explant consisted of paravalvular leak (moderate to severe), endocarditis, delayed migration causing paravalvular leak, and significant increase in aortic gradients despite anticoagulation therapy.Mean time elapsed between tav implant and explant was 674.9 days.Intra-operative surgical and pathological findings of explanted tavs included: vegetation/pus, calcification, thrombosis/clot, adhesions to aorta wall with neointima, migration, ¿not completely deployed¿ tav, fibrocalcific degeneration, pannus formation, fibrosis, chronic inflammation, and endocarditis.The authors noted that two ischemic strokes occurred in the early post-operative period in patients with self-expandable tavs that e xhibited significant adhesions to the ascending aorta due to neoendothelialization at explant.Following surgical tav explant and subsequent savr, adverse events included: need for post-operative intra-aortic balloon pump support, sternal infection, mechanical ventilation > 48 hours, atrial fibrillation, permanent pacemaker implantation, renal failure, and rehospitalization for cardiovascular causes during follow-up.Over a mean follow-up of 2.6 years after tav explant, 3 deaths occurred.No statement was made suggesting a causal or contributory relationship between medtronic product and the deaths.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: guimaron s, et al.Macroscopic and microscopic features of surgically explanted transcatheter aortic valve prostheses.Journal of cardiac surgery.2022 oct;37(10):3178-3187.Doi: 10.1111/jocs.16784.Epub 2022 jul 23.Earliest date of publication used for date of event.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.Patient age, gender, or weight cannot be provided due to regional privacy regulations.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
• 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: 15780271
• MDR Text Key: 303554934
• Report Number: 2025587-2022-03156
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2022
• 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): Hospitalization; Required Intervention