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

Model Number 40027

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

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that all leaflets were flexible and intact.No leaflet damage observed.All leaflets were in the closed position with a gap in the point of coaptation.All commissures were intact.No commissure damage was noted.The outer diameter measured at 34.95 mm, which is acceptable for a size 27 mm valve of this model.This valve was re-assessed for size confirmation and was confirmed to meet size requirements.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 valve measured to be of appropriate size.The sizer device was not returned for analysis.Based on the information available, the root cause of this complaint cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this bioprosthetic valve, the valve could not be seated.The valve was not fully sutured in, and it was removed and replaced with a non-medtronic valve.The physician felt the valve sizer "understated" the actual patient valve size.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: 11016973
• MDR Text Key: 223616325
• Report Number: 2025587-2020-03816
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983212
• UDI-Public: 00643169983212
• 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: 12/15/2020

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: 08/21/2021
• Device Model Number: 40027
• Device Catalogue Number: 40027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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: 25 YR
• Patient Weight: 65