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

Model Number 305C25

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Blood Loss (2597)

Event Date 09/26/2012

Event Type  Injury  

Manufacturer Narrative

Title: management of high-risk patients with aortic stenosis and coronary artery disease citation: the annals of thoracic surgery (2013) (doi 10.1016/j.Athoracsur.2012.07.075) authors: daniel wendt, md, philipp kahlert, md, tim lenze, markus neuhäuser, md, vivien price, thomas konorza, md, raimund erbel, md, heinz jakob, md, and matthias thielmann, md earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review regarding the outcome of patients after treatment of a percutaneous coronary intervention (pci) followed by the implant of a transcatheter bioprosthetic aortic valve compared with outcomes after coronary artery bypass graft (cabg) with concomitant surgical bioprosthetic aortic valve implant.All data were collected from a single center.The total study population included 243 patients; 51 of whom were implanted with medtronic mosaic valve and 17 of whom were implanted with a medtronic corevalve (serial numbers not provided).Of the patients implanted with a surgical valve, the mean age was 75 ± 6 years and 80 ± 6 years for that patient¿s implanted with a transcatheter valve.Among the patients implanted with a surgical valve adverse events included: 4 incidents of bleeding that was treated with re-exploration, 6 incidents of cerebral vascular accident at 30 days, and 8 incidents of permanent pacemaker implant.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC
• 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: 6298937
• MDR Text Key: 66426675
• Report Number: 2025587-2017-00189
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305C25
• Device Catalogue Number: 305C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 75 YR