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

Model Number 505D

Device Problems Incomplete Coaptation (2507); Device Damaged by Another Device (2915)

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

Event Date 09/13/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that following the implant of this 22 mm mechanical valve, the leaflet was not opening properly.The valve was explanted and replaced with a 20 mm valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve did not show evidence of impingement that may have contributed to leaflet motion.The carbon assembly, as received, did not rotate in the sewing ring.Green and white multifilament sutures were attached on the sewing ring.Both leaflets were received in the closed position.Using a blue actuator to test leaflet movement, the leaflets moved without difficulty.Both leaflets were intact with no evidence of damage or surface anomalies.Both inflow and outflow valve hinge mechanisms were intact.The inflow rim was intact.The outflow rim exhibited a fracture.The sewing cloth and lock ring area adjacent to the rim fracture showed damage.The lock ring was pulled away from the carbon assembly.The lock ring also showed teeth marks consistent with damage caused by an instrument/tool such as a hemostat clamp during explant.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 clinical observation could not be confirmed; no evidence of leaflet motion issue was noted.With the information available, the reported leaflet motion issue could be due to sizing.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: 7028205
• MDR Text Key: 91915760
• Report Number: 3008592544-2017-00062
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2021
• Device Model Number: 505D
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2016
• 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: 39 YR