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

Model Number 305

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

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226)

Event Date 04/23/2010

Event Type  Injury  

Event Description

Medtronic received information that this prosthetic aortic valve was part of a randomized clinical study entitled the nordic aortic valve intervention (notion) trial (physician sponsored study), designed to compare transcatheter and surgical valves from several manufacturers.Immediate postoperative the patient was noted to have a life threatening bleed and/ or tamponade.The intervention performed to fix the bleed is unknown at this time.The device remains implanted.

Manufacturer Narrative

The product remains implanted and therefore has not been returned to medtronic.Hemorrhage (acute blood loss or bleeding) is a known potential adverse effects per valve instructions for use.Based on the received information, the bleeding was resolved through unknown treatment.Tamponade also noted immediate postoperative.A device history review is not required as the event description does not indicate a potential manufacturing issue.The valve remains implanted and the patient continues to be monitored through the clinical trial.(b)(4).

Manufacturer Narrative

Immediately post implant of this bioprosthetic valve, bleeding was noted which caused tamponade.At re-operation, no distinct source for the bleed was found.The physician stated the bleed was not related to the valve.

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4476821
• MDR Text Key: 5325189
• Report Number: 2025587-2015-00117
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative,company represent
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2014
• Device Model Number: 305
• Device Catalogue Number: 305C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2009
• 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: 00079 YR
• Patient Weight: 80