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

Model Number 40023

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

Patient Problem Complete Heart Block (2627)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 620bg29, serial/lot #: (b)(4), pma #: k032810, ubd: 05-jul-2022, udi#: (b)(4).Product id: 900sfc32, serial/lot #: (b)(4), pma #: k093903, ubd: 11-jan-2024, udi#: (b)(4).Product analysis: the devices remains implanted; therefore, no product analysis can be performed.Conclusion: without the return of the products, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure and can be resolved with medical treatment or the implant of a permanent pacemaker.A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 5 days post implant of this 23mm bioprosthetic aortic valve, 12 days post implant of this 29 mm mitral annuloplasty band, and 12 days post implant of this 32mm tricuspid annuloplasty ring, a permanent pacemaker was implanted in the patient.The reason for the permanent pacemaker implant was reported as complete heart block.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: 10184011
• MDR Text Key: 196082269
• Report Number: 2025587-2020-01992
• 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: 06/23/2020

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: 01/08/2022
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 06/23/2020
• Date Device Manufactured: 01/09/2019
• 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: 63 YR