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

Model Number 501

Device Problem Mechanical Jam (2983)

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

Event Date 10/03/2015

Event Type  Injury  

Manufacturer Narrative

This initial report was manually submitted on (b)(6) 2015 during an fda known system outage.This is a re-submission.Product analysis: the product specimen has not been returned for analysis; however, the return is anticipated.Conclusion: without return of the product, no definitive conclusions could 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 during the implant of this 20mm mechanical valve a valve leaflet became stuck and did not open.The valve was explanted and replaced with a 18mm mechanical valve.No adverse patient effects were reported.

Manufacturer Narrative

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 explanted device has not been returned for analysis and the clinical observation cannot be confirmed.Based on the received information, a smaller valve was used as a replacement.Implantation of too big of a valve can cause anatomical issues which may inhibit leaflet motion.

Manufacturer Narrative

Analysis: this valve was received by medtronic plc attached to the valve holder, and secured in the inner packaging tray in the original product box.The valve was discolored, showing evidence of blood contact.The valve appeared to have been reattached to the valve holder due to a white suture wrapped around the valve holder adjacent to the holder jaw.The leaflets appeared intact with no evidence of damage.A blue actuator was used to test leaflet movement, and the leaflets appeared to move without difficulty.The assembly was moved back and forth to show the leaflets moved without difficulty as well.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.Conclusion: based on the analysis, the complaint could not be confirmed as no evidence of a leaflet motion issue was noted.

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: 5300108
• MDR Text Key: 33590921
• Report Number: 3008592544-2015-00049
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Model Number: 501
• Device Catalogue Number: 501DA20
• 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: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2014
• 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