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

Model Number T505

Device Problems Gradient Increase (1270); Structural Problem (2506); Incomplete Coaptation (2507)

Patient Problems Host-Tissue Reaction (1297); Thrombus (2101)

Event Date 11/04/2014

Event Type  Injury  

Event Description

Medtronic received information that an unidentified bioprosthetic valve had been explanted due to high gradient measurements approximately three years post-implant.It was reported that the hospital¿s pathology department had observed pannus and thrombus in their post-explant analysis.It also was reported that the sewing ring appeared inadequate and that the valve leaflets appeared misaligned.No additional details were reported.

Manufacturer Narrative

Without a serial number or explant date, it could not be immediately determined if this issue had previously been reported to medtronic or if the device had been returned for analysis.Additional information has been requested.(b)(4).

Manufacturer Narrative

Multiple attempts to obtain additional information have been unsuccessful.A device history record review could not be performed as the serial number was not provided.With only the received information, a root cause of the issues cannot be determined.

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 VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4281501
• MDR Text Key: 5009074
• Report Number: 2025587-2014-00968
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505-25H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• 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