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

Model Number 40021

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

Patient Problem Vascular Dissection (3160)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this patient underwent aortic valve replacement due to stenosis of her native aortic valve.The valve was sized for a 21mm bioprosthetic aortic valve.After placing the pledgeted sutures, the valve was resized.At this time it was noted that the 21mm "appeared to likely be a tight fit".The physician attempted to implant the 21mm valve.He reported that the valve would "barely fit" into the aorta, as well as that the patient's aorta and annulus were small.The surgeon was unable to seat valve on the annulus without obstructing both coronary ostia.It was reported that while attempting to seat the 21mm valve, there was "some" tearing of the aorta.The physician elected to not perform an annular enlargement due to the state of the patient's native tissue and anatomical factors.The physician subsequently implanted a 19mm bioprosthetic valve of the same model , which was reported to be a more appropriate size for the annulus.The patient tolerated the procedure well and no additional 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9653876
• MDR Text Key: 190684208
• Report Number: 2025587-2020-00338
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983182
• UDI-Public: 00643169983182
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2021
• Device Model Number: 40021
• Device Catalogue Number: 40021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 01/31/2020
• Date Device Manufactured: 10/12/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR