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

Model Number T505U

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 04/20/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant procedure of this 21 mm aortic bioprosthetic valve into the small root, which had a small left ventricular outflow tract (lvot) , the physician noted that after the device was fully sutured into place the leaflets were not properly coapting (pli10).As a result this device was removed and another valve was attempted.The second 21 mm aortic bioprosthetic valve (pli20) was sutured into place when the physician noted that there was "damage" of the device.At this time the second device was removed, and replaced with another 21 mm aortic bioprosthetic which remains implanted without issue.No additional adverse patient effects were reported. .

• 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: 7365739
• MDR Text Key: 103306648
• Report Number: 2025587-2018-00680
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169534087
• UDI-Public: 00643169534087
• 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
• Report Date: 03/23/2018

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: 02/07/2019
• Device Model Number: T505U
• Device Catalogue Number: T505U221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 03/23/2018
• Date Device Manufactured: 02/08/2016
• 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: 66 YR