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

Model Number FR99525

Device Problems Gradient Increase (1270); Obstruction of Flow (2423); Material Deformation (2976)

Patient Problems Aortic Regurgitation (1716); Pulmonary Regurgitation (2023); Stenosis (2263)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

Citation: korun o et al.Ross operation early and mid-term results in children and young adults.Anatol j cardiol.2019 jun;22(1):21-25.Doi: 10.14744/anatoljcardiol.2019.45751.Epub 2019 jun 14.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 following the ross procedure in children and young adults.All data were retrospectively collected from a single center between may 2003 and may 2018.The study population included 18 patients (predominantly female; median age 15 years), one was implanted with a medtronic contegra valved conduit and one was implanted with a medtronic freestyle bioprosthetic valve (no serial numbers provided).Among all patients, 3 early post-operative deaths occurred due to: cardiac arrest (1 case) and multi-organ failure (2 cases).Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: conduit stenosis requiring balloon angioplasty (1 case at 3 years post implant and 1 case at 8 years post implant), autograft/aortic root dilatation, elevated left ventricular outflow tract gradients, mild-moderate aortic and pulmonary insufficiency.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: 8848626
• MDR Text Key: 152915919
• Report Number: 2025587-2019-02436
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• 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: 15 YR