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); Reflux within Device (1522); Incomplete Coaptation (2507); Material Split, Cut or Torn (4008)

Patient Problems Pulmonary Edema (2020); High Pulmonary Arterial Wedge Pressure (2480); Cusp Tear (2656); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Citation: subahi a., et al.Balloon expandable transcatheter aortic valve implantation in failing self-expandable transcatheter valve in degenerated surgical bioprosthesis: valve-in-valve-in-valve implantation for the treatment of early degenerative prosthetic insufficiency.Oschner j., 2021 summer; 21(2):205-208.Published online june 2021.Pmid: (b)(4).Doi: 10.31486/toj.20.0011 earliest date of publish used for date of event.Medtronic products referenced: freestyle (pma# p970031, product code: lwr); corevalve (pma# p130021, product code: npt).Earliest approved product used for product code and pma#.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 a (b)(6)-year-old male patient with hypertension, hyperlipidemia, coronary artery disease, ischemic cardiomyopathy, a history of triple coronary artery bypass surgery in 2004, ascending aortic aneurysm repair and aortic valve replacement for severe aortic stenosis in 2012 using a 29-mm medtronic freestyle aortic root bioprosthesis (unique device identifier numbers not provided).In 2015, the patient developed acute severe aortic regurgitation from a tear in the freestyle left cusp.The patient underwent transcatheter valve-in-valve (viv) implantation of a 29-mm medtronic corevalve bioprosthesis (unique device identifier numbers not provided).In 2019, the patient was hospitalized with acute severe heart failure and pulmonary edema.Transesophageal echocardiography (tee) revealed high transvalvular gradients, severe central aortic regurgitation, secondary severe mitral regurgitation and pulmonary hypertension.The patient underwent transcatheter aortic valve-in-valve-in-valve replacement with a non-medtronic bioprosthesis and was later discharged from the hospital with improved symptoms.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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12322682
• MDR Text Key: 266594551
• Report Number: 2025587-2021-02553
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2021
• 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
• Treatment: VASCUTEK TERUMO AORTIC BIOPROSTHESIS.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR