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

Model Number 305U221

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

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Infarction, Cerebral (1771); Paresis (1998)

Event Date 06/14/2011

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, designed to compare transcatheter and surgical valves from several manufacturers.One day following the implant of this bioprosthetic valve the patient experienced , an ischemic cerebral vascular accident (cva) manifested by left hemiparesis.The patient had a history of atrial fibrillation (afib)/flutter.The patient was reported to be well with no further adverse patient effects at the 3 month follow up.

Manufacturer Narrative

Product analysis: the product remains implanted, therefore no product analysis can be performed.Conclusion: a variety of factors can influence the onset of stroke, and a conclusive cause was unable to be determined from the limited information available.The valve remains implanted and the patient continues to be monitored through the clinical trial.The patient had a history of atrial fibrillation/flutter.(b)(4).

Manufacturer Narrative

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 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: 4712461
• MDR Text Key: 19351945
• Report Number: 2025587-2015-00449
• 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,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2015
• Device Model Number: 305U221
• Device Catalogue Number: 305U221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2010
• 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): Other
• Patient Age: 00084 YR
• Patient Weight: 80