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

Model Number	510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Complete Heart Block (2627)
Date of Event	07/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the device remains implanted.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that 4 days post implant of this bioprosthetic valve, the patient developed complete heart block requiring the implant of a permanent pacemaker.Preoperative electrocardiogram (ecg) also revealed underlying sinus bradycardia with complete atrio-ventricular (av) block, left bundle branch block (lbbb) and right bundle branch block (rbbb) no other adverse patient effects were reported.Relevant medical history includes: mitral regurgitation, aortic regurgitation, tricuspid regurgitation, leaflet prolapse.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 6579126
• Report Number: 2025587-2017-00828
• Device Sequence Number: 82031
• Product Code: LWR
• UDI-Device Identifier: 00643169027121
• UDI-Public: 00643169027121
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: 510
• Device Catalogue Number: T510C31
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 96