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

Model Number 40021

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.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 customer noted the base of the valve was too firm and the coronary ostia became covered by the aorta.The valve was explanted and replaced with a non-medtronic valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis:upon receipt at medtronic¿s quality laboratory, visual examination revealed all the leaflets were in the closed position.All leaflets were intact and flexible.No leaflet damage was observed.All commissures were intact.No commissure damage was noted.Damage to the sewing ring was observed at l3.Damage to the fabric line adjacent to l2 was also observed.These damages likely occurred during explant.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 alleged ¿base of the valve was too firm¿ could not be confirmed as the valve met specification per medtronic¿s final inspection criteria.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AVALUS AORTIC TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7341687
• MDR Text Key: 102494768
• Report Number: 2025587-2018-00574
• 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,Followup
• Report Date: 04/19/2018

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: 03/06/2019
• Device Model Number: 40021
• Device Catalogue Number: 40021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 69