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

Model Number 505DA20

Device Problems Fracture (1260); Pitted (1460); Off-Label Use (1494); Unraveled Material (1664); Detachment of Device or Device Component (2907)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 06/06/2019

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 implant of this aortic mechanical valve placed in the mitral position, the surgeon used forceps to rotate the valve, which snapped the valve leaflet into several pieces.It is believed that all remnants have been removed from the patient.The valve was successfully replaced.No additional adverse patient effects were reported. .

Manufacturer Narrative

See additional device code in additional codes section product analysis: upon receipt at medtronic's quality laboratory, visual inspection revealed that sewing cuff was frayed.This fraying was consistent with the explant process.One intact leaflet, and three remnant leaflet pieces were returned.One leaflet remained attached to the valve.The fractured leaflet was broken into three pieces.The leaflet that remained attached to the valve moved without difficulty.A pitted area and chipped mark were observed on the attached leaflet.The valve orifice was intact with no evidence of damage.The inflow and outflow hinge mechanisms were intact as well.The carbon subassembly rotated within the sewing ring.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Possible causes of leaflet fracture include: using the jaw/holder end rather than the rotator end for valve rotation, or using other instruments for valve adjustment / rotation.In this case it was stated that the physician used forceps to rotate the valve, and that ultimately fractured the valve leaflet applied excessive force while rotating the valve leaflets, or valve rotation related risks are addressed in the current risk management file.A conclusive cause of this complaint cannot be determined.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, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8730415
• MDR Text Key: 149056457
• Report Number: 3008592544-2019-00027
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 MO