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

Model Number 500FA23

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507)

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

Event Date 11/03/2014

Event Type  Injury  

Event Description

Medtronic received information that this newly-implanted mechanical heart valve was explanted and replaced after ultrasound showed that the patient¿s mitral valve pressure gradient was high.The physician suspected that there was an issue with the device¿s leaflets.No information was provided regarding the replacement device.No subsequent adverse patient effects were reported.

Event Description

Subsequently it was reported that the observed high mitral valve pressure gradients were associated with a bioprosthetic mitral valve that was previously implanted prior to this procedure.

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.

Manufacturer Narrative

It was reported that the device will be returned for analysis.A supplemental report will be filed when the analysis/investigation is completed.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the device was found to be within specifications.The complaint could not be confirmed.After the carbon subassembly was cleaned and dried, the leaflets were fully mobile.The sewing cuff met specification for stitching and back-stitching.No as-manufactured surface finish anomalies were identified.The as-returned dimensions for the orifice, left, and right leaflets met engineering drawing specifications.The crown to notch (c-n) gap was measured.The as-returned gap for the left and right leaflets were within engineering drawing specification.The roundness of the stiffening ring was assessed.The difference between the minimum circumscribed and maximum inscribed stiffening ring dimensions was 0.0003 inch which is within the engineering drawing specification.

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 FLEX
• 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: 4243214
• MDR Text Key: 5015867
• Report Number: 3008592544-2014-00038
• 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: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2018
• Device Model Number: 500FA23
• Device Catalogue Number: 500FA23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/12/2015; 01/12/2015
• Supplement Dates FDA Received: 12/08/2014; 01/13/2015; 09/15/2017; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2013
• 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