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

Model Number 995

Device Problems Calcified (1077); Degraded (1153); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Dyspnea (1816); Endocarditis (1834); Low Cardiac Output (2501)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

Citation: schneider aw et al.Reinterventions after freestyle stentless aortic valve replacement: an assessment of procedural risks.Eur j cardiothorac surg.2019 dec 1;56(6):1117-1123.Doi: 10.1093/ejcts/ezz222.Advance access publication 19 august 2019.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 the different types of reinterventions that were performed in patients following aortic valve or root replacement with the freestyle stentless bioprosthesis.All data were retrospectively collected from a single center between 1993 and december 2018.The study population included 75 patients and was predominantly male with a mean age 62 years.All patients were previously implanted with medtronic freestyle bioprosthetic valves.No serial numbers were provided.Among all patients, 20 deaths were observed during the 10-year follow-up period.All the deaths occurred after the freestyle valves had been replaced.Based on the available information, medtronic product was not associated with the deaths.Among all patients, the median interval from freestyle implant to reintervention was 7.8 years (range of 3.5 to 12.6 years).Reinterventions included: redo aortic valve/root replacement or transcatheter valve-in-valve implantation due to structural valve deterioration (dyspnea due to increase of aortic regurgitation caused by leaflet tear or perforation) or non-structural valve deterioration (no further specifics were provided).Other adverse events that were observed: bioprosthesis calcification, dilatation of the aortic root, moderate-severe aortic regurgitation, and decreased left ventricular ejection fraction.Based on the available information, medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9777396
• MDR Text Key: 182001732
• Report Number: 2025587-2020-00647
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P970031
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2020
• 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: 62 YR