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 Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 09/01/2006

Event Type  Injury  

Manufacturer Narrative

Citation: bilal ms et al.Intermediate-term results of medtronic freestyle valve for right ventricular outflow tract reconstruction in the ross procedure.J heart valve dis.2006 sep;15(5):696-701.Doi: not available.Earliest date of publish used for event date (month and year valid).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 efficacy of alternative methods to the homograft valve for right ventricular outflow tract (rvot) reconstruction during the ross procedure.All data were collected from a single center between march 1997 and april 2005.The study population included 16 patients (predominantly male; mean age 18 years), 14 of which were implanted with medtronic freestyle bioprosthetic valves (no serial numbers provided).Among all patients, 2 deaths occurred due to: severe pneumonia at 6 months post implant and unknown causes at 3 years post implant.It was reported that the freestyle valves in both patients were ¿functioning normally at postoperative control echocardiography.¿ based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: valve explant and replacement due to pulmonary stenosis and increased peak gradient of 60 mmhg at 4 years post implant (one (b)(6)-year-old freestyle patient), elevated gradients, and mild regurgitation.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 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: 8841946
• MDR Text Key: 152669992
• Report Number: 2025587-2019-02396
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 07/10/2019
• 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: 18 YR