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

Model Number 500

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen was discarded by the user facility.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.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 during implant of this aortic mechanical valve, the suture ring dislodged during sewing.The device was explanted and replaced with a mechanical valve.No other adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the instructions for use for the open pivot mechanical heart valve contains a warning that states ¿it is suggested that only taper point needles be used for suturing the cuff as taper cut or other cutting needles may cut the cuff fibers.¿ there were no alleged deficiencies related to product quality/performance or manufacturing process.Based on the information available, it suggested that the event was due to user error.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 FLEX
• 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: 6589329
• MDR Text Key: 75892954
• Report Number: 3008592544-2017-00029
• 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: Initial,Followup,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 500
• Device Catalogue Number: 500FA25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2014
• 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