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

Model Number 505DA

Device Problems Inadequacy of Device Shape and/or Size (1583); Incomplete Coaptation (2507)

Patient Problem Occlusion (1984)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this 20mm aortic mechanical valve was implanted and explanted during the same procedure and was replaced with an 18mm mechanical valve of the same model.Post implant of the 20mm valve showed very small left ventricular outflowtract (lvot) and half of the valve orifice appeared to be obstructed by the reconstructed aortomitral curtain.The physician then decided to further augment the annulus by performing a root replacement.The valve was removed by cutting the sutures and the orifices of the proximal sites of the grafts were trimmed.The 20mm valve was once again implanted and sutured into place.Valve inspection then noted that one of the leaflets had become immobile due to bulging of the lvot tissue.The valve was removed and an 18mm valve was implanted.No additional adverse patient effects were reported. .

• 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: 6855666
• MDR Text Key: 85727553
• Report Number: 3008592544-2017-00047
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00643169335011
• UDI-Public: 00643169335011
• 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
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2019
• Device Model Number: 505DA
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2016
• 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: 54 YR
• Patient Weight: 69