MAUDE Adverse Event Report: HEART VALVES SANTA ANA 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); Heart Failure (2206); Cardiac Tamponade (2226)

Event Date 01/29/2010

Event Type  Injury  

Event Description

Medtronic received information that this prosthetic aortic valve was part of a randomized clinical study entitled (b)(6) (physician sponsored trial), designed to compare transcatheter and surgical valves from several manufacturers.During the implant of this valve the patient had a tamponade that led to a life threatening bleed.The patient had an intervention (unknown type) done to repair the tamponade.The patient was given a blood transfusion.Patient was also noted to have acute heart failure.The device remains implanted with no further adverse patient effects reported at that time.

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Cardiac dysrhythmias and hemorrhage (bleeding) are known potential adverse effects per the instructions for use.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.(b)(4).

Manufacturer Narrative

At reoperation, no specific bleeding source was identified.The physician stated the bleeding had no relationship to the valve.

Manufacturer Narrative

Additional information was received that during the procedure a supra-annular aortic patch was applied.

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): HEART VALVES SANTA ANA; 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: 4475928
• MDR Text Key: 5319931
• Report Number: 2025587-2015-00114
• 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,Followup
• Report Date: 03/30/2015

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: 10/27/2014
• Device Model Number: 305
• Device Catalogue Number: 305U21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2009
• 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): Life Threatening; Required Intervention
• Patient Age: 00081 YR
• Patient Weight: 65