MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305-19

Device Problems Structural Problem (2506); Patient-Device Incompatibility (2682)

Patient Problems Endocarditis (1834); Hemorrhage/Bleeding (1888); Thrombus (2101); Regurgitation (2259); Thromboembolism (2654)

Event Date 08/01/2002

Event Type  Injury  

Manufacturer Narrative

Citation: eichinger et al.European experience with the mosaic bioprosthesis.J thorac cardiovasc surg.2002 aug;124(2):333-9.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 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 prospective evaluation of the clinical and hemodynamic performance of the mosaic bioprosthesis.All data were collected from multiple centers between 1994 to may 1999.The study population included 561 patients (predominantly male, mean age 70 years), all of which were implanted with medtronic mosaic bioprosthesis (no serial numbers provided) in the atrial (461) or mitral position (100).Among all patients, adverse events included: structural valve deterioration, endocarditis, thromboembolism, nonstructural valve dysfunction, valve thrombosis, paravalvular leak (pvl), anti-thromboembolic hemorrhage, and reoperation or explant.Based on the available information medtronic product was associated with the adverse event(s).

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• 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: 8493920
• MDR Text Key: 141305813
• Report Number: 2025587-2019-01160
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990064
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305-19
• Device Catalogue Number: 305-19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 70 YR