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

Model Number 505DA20

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: 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 initial implant of this 20 mm aortic mechanical valve on this patient with severe stenosis, the physician measured a 20 mm valve and when implanted in the patient it did not fit well in the annulus.As a result, the valve was removed and a non medtronic valve was successfully implanted in its place.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed that the valve was returned discolored, showing evidence of blood contact, along with small needle holes on the sewing cuff, showing placement of implant sutures.Both leaflets were in the closed position with a slight gap.Using a blue actuator to test leaflet movement, the leaflets were limited in mobility.This was associated with the dried blood on the carbon component.Both leaflets were intact with no evidence of damage such as cracks and/or surface anomalies.The hinge orifice was intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms were intact.Remnants of dried blood was seen on the orifice and hinge mechanisms, resulting in limited leaflet mobility.The tissue annulus measured at 23.11 mm which met the specification for an open pivot ap 360 aortic valve size 20 mm.After the valve was cleaned and dried, a blue actuator was used to test the leaflet movement; the leaflets were fully mobile.Calibrated measure ments confirmed the device met specification for size.Conclusion: a review of the device history record (dhr) was performed for this valve; the device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The valve was returned for analysis.The valve annulus diameter was verified and meets the specification for the open pivot ap 360 aortic valve size 20 mm.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 9188623
• MDR Text Key: 162634570
• Report Number: 3008592544-2019-00049
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

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: 02/15/2024
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 11/01/2019
• Supplement Dates FDA Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 48