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

Model Number 501

Device Problem Structural Problem (2506)

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

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that immediately following implant of this mechanical aortic valve, the valve leaflets were not opening properly.Several attempts were made by the implanting physician to correct the situation, with no resolution.The valve was explanted and replaced with another device.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information from the physician stating that the leaflets of this valve were not moving properly due to the patient's anatomy.The valve was replaced with a mechanical valve.

Manufacturer Narrative

Product analysis: no product specimen has been returned.Conclusion: a review of the device history record (dhr) was performed for this valve; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The clinical observation cannot be confirmed; however, based on the available information, the physician's opinion regarding the leaflets was not moving properly could be due to the patient's anatomy.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.The valve appeared discolored showing evidence of blood contact.The valve¿s orifice appeared damaged exposing a section of the stiffening ring.A broken piece of the housing was received with the valve for analysis.Both leaflets were in the closed position.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices showed a break adjacent to one leaflet due to a broken piece of the housing.The broken section of the housing showed the serial number, which was verified.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.Exactly when or how the observed broken housing occurred could not be determined.In addition, the reported leaflet motion, per the physician¿s opinion, was due to the patient¿s anatomy.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.

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: 5039793
• MDR Text Key: 24515535
• Report Number: 3008592544-2015-00034
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Relabeling
• Type of Report: Followup,Followup,Followup,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2019
• Device Model Number: 501
• Device Catalogue Number: 501DA24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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