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

Model Number 995

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pleural Effusion (2010); Pericardial Effusion (3271); Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Citation: kyhl et al.Rheumatoid arthritis mimicking infective endocarditis with severe aortic regurgitation and aortic root abscess: a case report.European heart journal - case reports.2021 jan 25;5(1):ytaa561.Doi: 10.1093/ehjcr/ytaa561.Earliest date of publish used for date of event.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 severe aortic regurgitation (ar) who underwent successful implant of a medtronic freestyle bioprosthetic aortic root (unique device identifier numbers not provided).The postoperative period was complicated by pleural and pericardial effusions which required thoracentesis from both pleural cavities as well as pericardiocentesis.Due to 3rd degree atrioventricular block the temporary pacemaker was replaced by a permanent pacemaker.A week later, a transesophageal echocardiogram (toe) showed a well-functioning aortic prosthetic valve.Eight months post-surgery toe showed mild central aortic regurgitation (ar).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: 12218563
• MDR Text Key: 263459795
• Report Number: 2025587-2021-02357
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 07/23/2021

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: 07/12/2021
• Initial Date FDA Received: 07/23/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR