MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION VALVE T505-29H HANCOCK II AORTIC 29MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 17 years and 3 months post implant of this aortic bioprosthetic valve, the device was explanted and replaced for unknown reasons.No other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this aortic bioprosthetic valve was explanted and replaced due to structural valve dysfunction (svd) of the leaflet.Subsequently the patient also required an aortic root replacement and was implanted with an aortic root bioprosthesis.Added weight to pt weight.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALVE T505-29H HANCOCK II AORTIC 29MM
• 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: 6774608
• MDR Text Key: 82069621
• Report Number: 2025587-2017-01345
• Device Sequence Number: 1
• 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
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505-29H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 75 YR
• Patient Weight: 90