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

Model Number T505U223

Device Problem Insufficient Information (3190)

Patient Problems Aortic Insufficiency (1715); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 4 years 2 months post implant of this 23mm aortic bioprosthetic valve, the patient is being considered for valve-in-valve replacement due to unknown reasons.Subsequently 22 days later the patient successfully had an aortic valve-in-valve replacement with a transcatheter valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the reason for replacement was due to severe aortic insufficiency.No additional adverse patient effects were reported.  added patient weight.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART 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: 7731788
• MDR Text Key: 115403270
• Report Number: 2025587-2018-01911
• Device Sequence Number: 0
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• 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,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2016
• Device Model Number: T505U223
• Device Catalogue Number: T505U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 98