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

Model Number 505DA18

Device Problem Mechanical Jam (2983)

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

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product has been returned.Conclusion: based on the information available, no conclusion can be drawn with this event.Additional information regarding the nature and details of the event have been requested, but not received at the time of this report.When the complaint product has been evaluated and additional event information received, a follow-up report will be submitted.(b)(4).

Event Description

Medtronic received information that following implant of this 18mm mechanical valve, the valve was explanted and replaced with a non medtronic 19mm valve due to leaflet impingement.The physician reported that the implant was difficult.No product performance issues were detected prior to implant, and no adverse patient effects were reported.Post explant, the physician reported there were no abnormalities with the valve.

Manufacturer Narrative

Additional information was received from the implanting physician that this valve could not be implanted due to the patient's physiology, and that there was no product problem.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt of the returned product specimen, the valve appeared clean with no evidence of blood contact.The valve did not show evidence of the reported impingement.Both leaflets were observed in the closed position and appeared to be intact with no evidence of damage, such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms and orifices appeared to be intact with no evidence of damage.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.The root cause of the reported issue could not be determined as the valve was inspected and tested and no anomalies were found.Based on the additional information received, the reported issue has been attributed to the patient¿s physiology and not the device.

Manufacturer Narrative

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.

• 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: 5027824
• MDR Text Key: 23950406
• Report Number: 3008592544-2015-00032
• 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,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: 505DA18
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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