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

Model Number	505DA
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Incomplete Coaptation (2507)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6855666
• Report Number: 3008592544-2017-00047
• Device Sequence Number: 800511
• Product Code: LWQ
• UDI-Device Identifier: 00643169335011
• UDI-Public: 00643169335011
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2019
• Device Model Number: 505DA
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 69