MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 503DA22

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from the patient that 12 years and 5 months post implant of this aortic mechanical valve, the valve was explanted and replaced with a non-medtronic bioprosthetic valve.The patient stated their valve was "diseased and growing bacteria".No additional adverse patient effects were reported. .

Manufacturer Narrative

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

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8066249
• MDR Text Key: 127050303
• Report Number: 3008592544-2018-00051
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2010
• Device Model Number: 503DA22
• Device Catalogue Number: 503DA22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/13/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 11/16/2018
• Date Device Manufactured: 06/20/2005
• 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: 68 YR
• Patient Weight: 104