MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AVALUS AORTIC TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 40023

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual analysis revealed that the valve was discolored showing evidence of blood contact.Damage to the sewing ring between l2 and l3 was observed, which likely occurred during explant.All leaflets were in the closed position.All leaflets were flexible.All leaflets appeared intact.No leaflet damage observed.All commissures were intact.No commissure damage noted.Analysis showed that green markers on the sewing cuff did not properly align with the stent posts as is indicated in the manufacturing process.The outer diameter of the valve was measured and found acceptable per specification of this valve size and model.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.The sewing cuff was measured, and it is within the specification.The analysis confirmed that the sewing markers are not located at the mid sinus area of each cusp for this valve, which contributed to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 23mm bioprosthetic valve, prior to insertion the physician noted the markers on the sewing cuff were not symmetrical and the sewing cuff appeared to be larger than expected.The physician continued to attempt to place the valve, however it would not pass through the sinotubular junction (stj).The valve was removed and an annular enlargement was performed.Sizing was repeated and a 21mm bioprosthetic valve was successfully implanted.No adverse patient effects were reported.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11017399
• MDR Text Key: 223615705
• Report Number: 2025587-2020-03825
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983199
• UDI-Public: 00643169983199
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170006
• 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
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 80