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

Model Number 305_MOSAIC

Device Problems Occlusion Within Device (1423); Perivalvular Leak (1457)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Endocarditis (1834); Hemorrhage/Bleeding (1888); Thrombus (2101); Thromboembolism (2654)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

Citation: rie fc long-term outcomes of the mosaic bioprosthesis.Ann thorac surg.2018 mar;105(3):763-769.Doi: 10.1016/j.Athoracsur.2017.09.053.Epub (b)(6) 2017.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding long-term outcomes of the mosaic bioprosthesis.All data were collected from multiple centers between february 1994 and november 2000.The study population included 1,029 patients (predominantly male; mean age 69 years), 797 patients were implanted with medtronic mosaic valve in aortic position and 232 patients were implanted with medtronic mosaic valve in mitral position.The serial numbers were not provided.Among all patients 37 deaths were characterized as valve-related due to permanent neurological event, endocarditis, structural valve dysfunction (svd), sepsis, myocardial infarction (mi), congestive heart failure (chf), cardiac failure and hemorrhage.Based on the available information, none of these deaths were attributed to medtronic product.Among all patients adverse events included: structural valve dysfunction (svd) in form of calcification, tears and perforations, degeneration, fenestration, refraction, and prolapse of the non-coronary cusp, severe aortic regurgitation (ar),moderate mitral regurgitation, mitral stenosis, aortic stenosis, bleeding, valve thrombosis, thromboembolism and permanent neurological event.Based on the available information, a direct correlation was likely between the observed adverse events and medtronic product.No additional adverse patient effects or product performance problems were reported.

Manufacturer Narrative

Additional review revealed the study referenced within the literature to be sponsored by medtronic, and that the clinical observations from the study population have been previously reported at the patient level.If information is provided in the future, a supplemental report will be issued.

• 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: 7534572
• MDR Text Key: 108939477
• Report Number: 2025587-2018-01246
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305_MOSAIC
• Device Catalogue Number: 305_MOSAIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR