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 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visualize analysis revealed that the valve was discolored showing evidence of blood contact.All leaflets were in the closed position with a gap at the point of coaptation.All leaflets were flexible and appeared intact.The outer diameter of the valve measured at 30.35 mm, which is acceptable for a valve of this size and model.This valve was re-assessed for size confirmation.This valve 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.A conclusive cause could not be determined as the returned product was measured and found acceptable.The valve was unable to be seated without blocking the coronary arteries and/or being tilted in orientation.It was reported that this patient's native anatomy made the implant more challenging from a technical perspective which could be a possible cause of the valve not being able to be implanted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this patient's native aortic valve annulus was sized for a 21mm bioprosthetic valve.Prior to replacing the valve, a (b)(6) technique aortic root enlargement was performed by a cardiac surgery fellow.The valve was re-sized using both the barrel and replica ends of the sizer, and a 23mm valve was selected.The medtronic representative had previously instructed this attending surgeon to re-size the valve after placement of the pledgets.In this case, the valve was not resized following pledget placement.While attempting to parachute the valve down into the annulus with the cor-knot device, the valve was unable to be seated without blocking the coronary arteries and/or being tilted in orientation.As such, the 23mm valve was unable to be sutured into place and was removed.A 21mm valve was successfully implanted.No adverse patient effects were reported.Of note, it was reported that this procedure was the surgeon's sixth time using this valve, and the smallest valve of this model that he had implanted previously was a 25mm valve in a patient with annular enlargement.It was reported that this patient's native anatomy made this implant more challenging from a technical perspective.

• 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: 11017194
• MDR Text Key: 223617471
• Report Number: 2025587-2020-03820
• 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: 12/15/2020

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 Expiration Date: 11/28/2021
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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: 55 YR
• Patient Weight: 77