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

Model Number 501

Device Problem Incomplete Coaptation (2507)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for analysis, however, the return is anticipated.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that following implant of this 24mm mechanical aortic valve, this valve was explanted and replaced due to a suspected stuck leaflet.During implant, the motion of the valve leaflets were checked and no issues were observed.The implanted valve was properly sized.After closing the aorta and going off pump, patient was observed to be in fibrillation.No valve sound was detected, and valve movement could not be manually sensed.Valve leaflet movement could not be visualized by using imaging techniques.The patient was put back on cross clamp, cardioplegia re-introduced and the aorta was reopened.No sticking of the leaflets was observed at that time, however the surgeon explanted the valve.After explantation, the valve was checked again for leaflet movement and one leaflet was observed to get stuck during opening and closing.In the physician's opinion, the valve was contributing to this patient condition.A 22mm mechanical valve was then implanted.After the implantation of the new valve no fibrillation was observed, leaflet movement appeared to be normal under scope.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was evaluated.The sewing ring was found to be discolored and showed evidence of blood contact.There was no evidence of impingement to impact leaflet motion.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms and orifices appeared intact with no evidence of damage.During functional leaflet motion testing, 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 analysis, the complaint could not be confirmed and there was no evidence of a leaflet motion issue; however, based on the received information, a smaller valve was used to be the replacement.While no true root cause could be determined, implantation of too large a valve may have caused anatomical issues, which is a potential root cause to inhibiting leaflet motion.

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: 5165657
• MDR Text Key: 28837906
• Report Number: 3008592544-2015-00040
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2018
• Device Model Number: 501
• Device Catalogue Number: 501DA24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2013
• 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
• Patient Age: 00031 YR
• Patient Weight: 145