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

Model Number 500FA25

Device Problem Material Separation (1562)

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

Event Date 11/05/2014

Event Type  Injury  

Event Description

Medtronic received information that during the attempted implant of this mechanical heart valve, the suturing ring separated from the valve body.The valve was removed and successfully replaced by another valve.Additional information was received that the suturing ring separated during the suturing process.No adverse patient effects were reported.

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Manufacturer Narrative

Review of the device history record showed that this device was built to specification and met all inspection and acceptance criteria.There were no non-conformances or reworks/deviations noted that would have impacted this event.Specifically, no anomalies were noted with regard to the sewing cuff assembly process.

Manufacturer Narrative

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.It was reported that a cutting needle was used during the procedure and that the suturing ring separated during the suturing process.The instructions for use for this device have a warning that states: ¿when securing the valve in place, suture needles should be passed through the outer half of the sewing cuff and suture ends should be cut short after the knots are tied.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.¿ however, the valve was not returned for analysis, therefore a conclusive cause of the reported event could not be determined.

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: 4287152
• MDR Text Key: 5196825
• Report Number: 3008592544-2014-00040
• 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
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2019
• Device Model Number: 500FA25
• Device Catalogue Number: 500FA25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/03/2014
• 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
• Patient Age: 00036 YR