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

Model Number T505C2

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

Patient Problems Syncope (1610); Arrhythmia (1721)

Event Date 03/19/2018

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 immediately following the implant of this bioprosthetic valve, the electrocardiogram (ecg) showed third degree heart block that transitioned into second degree heart block.The temporary pacemaker remained in use until four days post implant.Beta blockers were not used due to the extension of the temporary pacemaker.The rhythm returned to normal sinus, however, 14 days post implant, a permanent pacemaker was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that upon discharge, the patient was in normal sinus rhythm.Twenty-nine days post valve implant, the patient experienced a syncopal episode that resulted in the implant of a permanent pacemaker 33 days post valve implant.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: 7450317
• MDR Text Key: 106155779
• Report Number: 2025587-2018-00941
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594319
• UDI-Public: 00643169594319
• 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: 06/05/2018

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: 09/04/2020
• Device Model Number: T505C2
• Device Catalogue Number: T505C225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 05/24/2018
• Supplement Dates FDA Received: 06/05/2018
• Date Device Manufactured: 09/05/2017
• 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: 81 YR
• Patient Weight: 81