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

Model Number 305-19

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Stroke/CVA (1770); Endocarditis (1834); Myocardial Infarction (1969); Thrombus (2101); Transient Ischemic Attack (2109); Blood Loss (2597); Thromboembolism (2654)

Event Date 08/19/2009

Event Type  Injury  

Manufacturer Narrative

Citation: riess et al."clinical results of the medtronic mosaic porcine bioprosthesis up to 13 years." eur j cardiothorac surg.2010 jan; 37 (1): 145-53.Doi: 10.1016/j.Ejcts.2009.04.073.Epub 2009 aug 19.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 13-year clinical results of the medtronic mosaic porcine bioprosthesis.All data were collected from a single center between february 1994 and october 1999.The study population included 255 patients (predominantly male, mean age 67 years) who underwent aortic valve replacement and 47 patients (predominantly female, mean age 67 years) who underwent mitral valve replacement with a medtronic mosaic bioprosthetic valve (no serial numbers provided).Among aortic valve replacement patients two notable early deaths occurred within 30 days of surgery or before discharge.The first death was on postoperative day 3 due to hypertrophic obstructive cardiomyopathy with left ventricular outlet obstruction.The second death was on postoperative day 13 due to acute pericardial tamponade after aortic dissection and perforation.Based on the available information medtronic product may have been associated with these two early deaths.Among aortic valve replacement patients, adverse events included: structural valve dysfunction, pannus, thromboembolism (permanent neurological event, transient neurological attack, peripheral embolic event), acute myocardial infarction, valvular thrombosis, endocarditis, major bleeding, valve-related reoperation.Based on the available information medtronic product was associated with the adverse event(s).Among mitral valve replacement patients, adverse events included: structural valve dysfunction, thromboembolism (permanent neurological event, peripheral embolic event), endocarditis, major bleeding, and valve-related reoperation.Based on the available information medtronic product was associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• 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: 8502250
• MDR Text Key: 141576813
• Report Number: 2025587-2019-01182
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• 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: 67 YR