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

Model Number 502AG29

Device Problem Insufficient Information (3190)

Patient Problem Blood Loss (2597)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted; therefore, no product was returned.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 during the implant of this 29mm aortic mechanical valved conduit as part of a bentall procedure, it was reported that the case was complex and took more time than usual.At the latter part of the procedure, the surgeon reported that the graft hemashield was porous and this does not occur in more straightforward cases.A reoperation was performed on the same day to perform hemostasis.No additional adverse patient effects were reported.

• Brand Name: AORTIC VALVE GRAFT
• 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: 9842993
• MDR Text Key: 183753607
• Report Number: 3008592544-2020-00020
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: RP
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2020

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: 08/13/2019
• Device Model Number: 502AG29
• Device Catalogue Number: 502AG29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/17/2020
• Date Device Manufactured: 08/14/2014
• 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