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

Model Number 995

Device Problem Incomplete Coaptation (2507)

Patient Problems Aortic Regurgitation (1716); Calcium Deposits/Calcification (1758); Stenosis (2263)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Citation: (b)(6) et al.Early outcomes for valve-in-valve tavr in degenerative freestyle bioprostheses.Seminars in thoracic and cardiovascular surgery (2017) doi 10.1053/j.Semtcvs.2017.11.001 earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding the outcomes after the implant of a valve-in-valve transcatheter aortic valve (tavr) into a freestyle stentless bioprosthesis.All data were collected from a single center between 2014 and 2016.The study population included 22 patients, who were implanted with a corevalve or an evolut r transcatheter bioprosthetic aortic valve.Serial numbers were not provided.The study population was predominantly male; mean age 74 + 9 years.Among all patients previously implanted with a freestyle, adverse events included: severe regurgitation due to flail leaflet or malcoaptation leaflet, severe stenosis, and calcification.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: 7126160
• MDR Text Key: 95170577
• Report Number: 2025587-2017-02480
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2017

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: 11/27/2017
• Initial Date FDA Received: 12/18/2017
• 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: 74 YR