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

Model Number FR99525

Device Problems Gradient Increase (1270); Material Separation (1562); Material Deformation (2976)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 02/03/2015

Event Type  Injury  

Manufacturer Narrative

Citation: juthier f et al.Stentless porcine bioprosthesis in pulmonary position after ross procedure: midterm results.Ann thorac surg.2015 apr; 99 (4): 1255-9.Doi: 10.1016/j.Athoracsur.2014.10.033.Epub 2015 feb 3.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the outcomes in patients following the ross procedure using stentless porcine roots in the pulmonary position.All data were collected from single center between march 1992 and february 2011.The study population included 61 patients (predominantly male; mean age 38 years), 38 of which were implanted with medtronic freestyle bioprosthetic valves (no serial numbers provided).Among all patients, three deaths occurred within 30 days post implant due to: multi-organ failure resulting from endocarditis present at baseline (2 cases) and hemorrhagic stroke (1 case).During the follow-up period, 2 late deaths occurred due to: cirrhosis (1 case) and suicide (1 case).Multiple manufacturers were noted in the literature; based on the available information, medtronic product was directly associated with the deaths.Among all patients, adverse events included: autograft reoperation (4 reoperations were due to significant insufficiency, 1 was due to dilatation over 50 mm with significant regurgitation, and 1 was due to proximal anastomosis dehiscence).It was reported that no abnormalities were present on the stentless roots during each reoperation.Additional adverse events included: mild-moderate-severe regurgitation and elevated gradients.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: FREESTYLE
• 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: 8852538
• MDR Text Key: 153088439
• Report Number: 2025587-2019-02449
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FR99525
• Device Catalogue Number: FR99525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/01/2019
• 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: 38 YR