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

Model Number 995

Device Problems Calcified (1077); Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Endocarditis (1834); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 05/23/2012

Event Type  Injury  

Manufacturer Narrative

Citation: miskovic a et al."comparison between homografts and freestyle® bioprosthesis for right ventricular outflow tract replacement in ross procedures." eur j cardiothorac surg.2012 dec; 42 (6): 927-33.Doi: 10.1093/ejcts/ezs185.Epub 2012 may 23.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 the 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 outcomes for patients who underwent right ventricular outflow tract replacement with either a homograft or a stentless bioprosthetic valve following the ross procedure.All data were collected from a single center between january 1996 and july 2011.The study population included 186 patients (predominantly male; mean age 44 years), 73 of which were implanted with a medtronic freestyle bioprosthesis (no serial numbers provided).Among all freestyle patients, 2 deaths occurred within 30 days post implant.It was reported that no death was related to the right ventricular outflow tract valve.Based on the available information, medtronic product was not directly associated with the death(s).Among all freestyle patients, adverse events included: transcatheter valve-in-valve implantation (noted to be with the medtronic melody transcatheter valve), valve surgically removed and replaced with a homograft, balloon dilatation, pulmonary stenosis, pulmonary regurgitation, endocarditis, subvalvular stricture at the suture line, valve walls calcified, early valve recalcification, and gradients greater than or equal to 40 mm hg.Based on the available information, medtronic product was directly associated with the adverse event(s).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: 8479990
• MDR Text Key: 140818220
• Report Number: 2025587-2019-01107
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/03/2019
• 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: 44 YR