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

Model Number 305_MOSAIC

Device Problems Gradient Increase (1270); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Thrombus (2101); Blood Loss (2597); Thromboembolism (2654)

Event Date 12/18/2014

Event Type  Injury  

Manufacturer Narrative

Citation: andreas m et al.Comparable long-term results for porcine and pericardial prostheses after isolated aortic valve replacement.Eur j cardiothorac surg.2015 oct;48(4):557-61.Doi: 10.1093/ejcts/ezu466.Epub 2014 dec 18.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 the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the long-term outcomes for patients who underwent isolated aortic valve replacement with either a pericardial prosthesis or a porcine prosthesis.All data were collected from a single center between 2002 and 2008.The study population included 458 patients (predominantly female; mean age 74 years; mean weight 78 kg), 163 of which were implanted with a medtronic mosaic bioprosthetic valve (no serial numbers provided).Among all mosaic patients, 5 early deaths occurred (early mortality was defined as all-cause mortality during the first 30 days) and 54 deaths occurred during the follow-up period (noted to be 0 to 11 years).Based on the available information, medtronic product was not directly associated with the death(s).Among all mosaic patients, adverse events included: valve-in-valve implantation, reoperation/reintervention, stroke, transient ischemic attack, embolism, myocardial infarction, endocarditis, revision for bleeding, bleeding event, valve thrombosis, moderate-severe prosthesis patient mismatch, and increased mean transvalvular gradients.Based on the available information, medtronic product was directly 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, REPLACEMENT
• 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: 8470295
• MDR Text Key: 140511316
• Report Number: 2025587-2019-01086
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 03/06/2019
• 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): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 78