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

Model Number 995CS23

Device Problem Complete Blockage (1094)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Foreign Body Reaction (1868); Tachycardia (2095); Obstruction/Occlusion (2422); Cardiovascular Insufficiency (4445)

Event Date 03/24/2011

Event Type  Death  

Manufacturer Narrative

Citation: o¿keefe k., et al.Early catastrophic stentless valve failure secondary to possible immune reaction.Annals of thoracic surgery, april 2011; 91(4):1269-1272.Doi: 10.1016/j.Athoracsur.2010.09.042.Available online 24 march 2011.Earliest date of publish used for event date and death date.Medtronic products referenced: freestyle (pma# p970031, product code: lwr).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 of a case report involving two patients with immunologic reactions to bioprosthetic aortic root implants.The first patient was an (b)(6)-year-old woman with coronary artery disease status-post revascularization, hyperlipidemia and atrioventricular block requiring a pacemaker, severe aortic stenosis and moderate aortic insufficiency.The patient was implanted with a 23-mm medtronic freestyle bioprosthetic aortic root (no serial numbers provided).Approximately 3.5 months post-implant, the patient was re-hospitalized with angina and tachyarrhythmias.Urgent cardiac catheterization revealed coronary vein graft occlusions and during emergency surgery, dense scarring was noted around the freestyle aortic root.The patient later expired in the intensive care unit (icu) and an autopsy revealed intense fibrosis and inflammation due to a foreign body reaction around the xenograft.The second patient was a (b)(6)-year-old obese woman with hypertension, hyperlipidemia, reflux disease, sleep apnea and severe aortic stenosis.The patient was implanted with a 25-mm medtronic freestyle bioprosthetic aortic root (no serial number provided).Six months post-implant, the patient developed anginal symptoms with crushing chest pain.The patient was hospitalized and urgent cardiac catheterization revealed left main coronary artery occlusion.During that procedure, the patient went into cardiac arrest and expired.An autopsy revealed significant scar tissue filling the right/left ostia and along the surface of the bioprosthetic root with inflammation due to a foreign body reaction.Based upon the available information, medtronic product may have been associated with the adverse events and deaths.

• 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: 11127406
• MDR Text Key: 225470952
• Report Number: 2025587-2021-00044
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 995CS23
• Device Catalogue Number: 995CS23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR