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

Model Number 40025

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned as the product referenced was a demonstration product, and there was no indication of a product problem.Please note the product referenced here was not a commercially distributed product.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this surgeon had never used this model of bioprosthetic aortic valve.As a result, prior to surgery, the surgeon compared the size of the medtronic demonstration valve to the medtronic demonstration valve sizer.It was reported that the surgeon did not like how the ends of the sizer did not "match up effectively" when compared the actual valve size.The surgeon reported that the size of the valve was larger than the corresponding size on the sizer.The sales rep was present with the surgeon, and the sales rep explained how to use the sizing tool for this valve.Ultimately the surgeon felt that it would be a hard valve to size accurately and decided not to use this model valve.There was no patient involvement in this case.

• 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: 11017231
• MDR Text Key: 221767192
• Report Number: 2025587-2020-03822
• Device Sequence Number: 1
• Product Code: LWR
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40025
• Device Catalogue Number: 40025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• 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