MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505D

Device Problem Mechanical Jam (2983)

Patient Problems Corneal Pannus (1447); Thrombus (2101)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device has not been returned for evaluation.Conclusion: based on the received information the leaflet motion was caused by thrombus formation.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.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 mechanical valve was implanted in the mitral position with a 20 mm gore-tex graft skirting the valve to prevent against pannus formation.Following implant, a leaflet dysfunction was observed, presumably resulting from pannus on the graft.Approximately six months post-implant of this device, surgical intervention was undertaken to remove a thrombus attached to the leaflet and correct the observed leaflet dysfunction; the device was not replaced.No other adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT AP360 HEART VALVE
• 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: 6505182
• MDR Text Key: 73215302
• Report Number: 3008592544-2017-00020
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Model Number: 505D
• Device Catalogue Number: 505DM16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 4