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

Model Number 505DA22

Device Problem Gradient Increase (1270)

Patient Problem Aortic Regurgitation (1716)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has been returned and analysis is in progress.Upon completion of the analysis, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that during implant of this bioprosthetic valve, an ultrasound revealed regurgitation and unacceptable hemodynamics; therefore, the device was removed and replaced.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: 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.Upon receipt at medtronic's quality laboratory, visual inspection found the valve discolored, showing evidence of blood contact.A 1.5 cm opening was observed along the stitching in the sewing cuff flange; it was determined that this was due to a cut suture during implant.Both leaflets were in the closed position and were intact with no evidence of damage or surface anomalies.Both inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.Remnants of coagulated blood were observed along the outflow orifice.Using a blue actuator to test the leaflet movement, the leaflets moved without difficulty.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.The sewing ring was removed by systematically undoing the stitching to expose the stiffening ring window.The lockwire was pulled out and the stiffening ring was removed from the orifice.The serial number was verified.Conclusion: a conclusive cause of the reported event could not be determined, as the device met specification.

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: 5008301
• MDR Text Key: 23189654
• Report Number: 3008592544-2015-00031
• 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: Followup,Followup
• Report Date: 11/03/2015

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: 03/20/2020
• Device Model Number: 505DA22
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided; 11/03/2015
• Supplement Dates FDA Received: 11/09/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2015
• 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