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

Model Number 501

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, however, the return is anticipated.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or 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 immediately following implant of this mechanical valve using the ats sizer, it was explanted and replaced as it would not pass the annulus.There was no allegation against the valve itself.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the sewing ring was discolored showing evidence of blood contact.Suture holes were noted on the sewing ring.Both leaflets were in the closed position.Both leaflets were intact with no evidence of damage such as cracks and/or surface anomalies.The inflow and outflow valve hinge mechanisms were intact.The inflow and outflow orifices were intact with no evidence of damage.The valve met the manufacturing specification for the outer diameter of the sewing ring for a size 22 valve.Per the instructions for use, the valve met the manufacturing specification for the tissue annulus for a size 22 valve.It is unlikely that this size 22 valve was packaged with a size 20 holder.The returned size 20 holder was attached to the returned valve as directed by the quality engineer and it showed looseness between the valve and holder.Per manufacturing, there is a 100% visual inspection of the holder body/jaw.Using a blue actuator to test leaflet movement, the leaflets appeared to move 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 lock wire was pulled out and the stiffening ring removed from the orifice.Conclusion: 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.Based on the reported information, the cause of the event was a sizing issue which could potentially be due to technical error.The device is considered acceptable.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 AP
• 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: 6578894
• MDR Text Key: 75593600
• Report Number: 3008592544-2017-00027
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2019
• Device Model Number: 501
• Device Catalogue Number: 501DA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2014
• 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