MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AORTIC FLEX; HEART-VALVE, MECHANICAL

Model Number 500FA21

Device Problem Crack (1135)

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

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during suturing of this aortic mechanical valve, it was reported the suture ring was not firm and cracking.Therefore the mechanical valve was not implanted and replaced with a valve of the same size and model.No additional adverse patient effects were reported. .

• Brand Name: AORTIC FLEX
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8303002
• MDR Text Key: 134934742
• Report Number: 3008592544-2019-00004
• 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
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: 500FA21
• Device Catalogue Number: 500FA21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Date Device Manufactured: 07/13/2016
• 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: 40 YR
• Patient Weight: 58