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

Model Number 505

Device Problem Fracture (1260)

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

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has been returned and analysis is in progress.Conclusion: upon completion of analysis, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that during the implant of this mechanical valve, one of the valve leaflets broke off while the physician was adjusting the valve flow outlet and rotating the valve after the valve was sutured into place.The physician stated that too much force was used while rotating the valve leaflets.A medtronic mechanical valve of the same model was implanted successfully during the procedure.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned specimen was inspected.One leaflet appeared to be intact and in the closed position.This leaflet showed no evidence of damage such as cracks and/or surface anomalies.Overall, the valve appeared to be clean with no evidence of blood contact.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appeared intact with no evidence of damage.Using a blue actuator to test leaflet movement, the remaining leaflet appeared to move without difficulty.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.The sewing ring was removed by systematically undoing the stitching to expose the stiffening ring window.The lock wire was pulled out and the stiffening ring removed from the orifice.The serial number was verified.Conclusion: based on the analysis and the reported information, the leaflet fracture was due to excessive force while rotating the valve leaflets by the physician.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

Manufacturer Narrative

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5135334
• MDR Text Key: 27818339
• Report Number: 3008592544-2015-00039
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 01/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: 505
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2013
• 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: 00050 YR