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

Model Number 505

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Mechanical Jam (2983)

Patient Problem Hemolytic Anemia (2279)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen has not been returned for device evaluation.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.

Event Description

Medtronic received information that following implant of this aortic mechanical valve, fluoroscopy indicated that a valve leaflet may be stuck; however, echocardiogram indicated that the leaflets appeared fine.The surgeon surmised that a pledget was impinging a leaflet.Post operative mean gradients were measured at 20 mmhg, and the patient presented with hemolytic anemia.29 days post implant, the patient presented with paravalvular leak and increased mean gradients measuring 40mmhg.This valve was explanted and replaced with a tissue valve.

Manufacturer Narrative

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.

Manufacturer Narrative

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

Manufacturer Narrative

Updated explant date.Corrected manufacturer received date.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: 6123071
• MDR Text Key: 60743049
• Report Number: 3008592544-2016-00061
• 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,Followup,Followup
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2018
• Device Model Number: 505
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2015
• 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: 58 YR
• Patient Weight: 69