MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION AORTIC VALVE GRAFT; HEART-VALVE, MECHANICAL

Model Number 502AG27

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemoptysis (1887); No Information (3190)

Event Date 10/05/2018

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 that 8 years and 1 month post implant of this mechanical aortic valved graft, the graft was explanted and replaced with a bioprosthetic valve.The reason for replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the patient had hemoptysis and needed off warfarin.The physician reported there was no failure of the mechanical valved graft.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC VALVE GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8102976
• MDR Text Key: 128312568
• Report Number: 3008592544-2018-00055
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2012
• Device Model Number: 502AG27
• Device Catalogue Number: 502AG27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• Date Device Manufactured: 09/11/2009
• 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: 59 YR
• Patient Weight: 86