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

Model Number HC105

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pulmonary Valve Stenosis (2024); Regurgitation, Valvular (2335); No Information (3190)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

The available information indicates the device remains implanted.Additional information has been requested regarding the device's functionality, any adverse patient effects and the patient's weight.A supplemental report will be filed if additional information is received and/or when investigation is completed.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 approximately nineteen years, two months post-implant of this bioprosthetic pulmonic valve, this device was replaced valve-in-valve with a transcatheter bioprosthetic device.No specific failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was replaced due to severe conduit dysfunction with regurgitation and stenosis.The severity of the regurgitation was not indicated.Prior to the replacement, the patient presented with increasing symptoms of dyspnea on exertion, palpitations, and fatigue.Following the replacement procedure, the patient is doing well, but might have underlying pulmonary vascular disease.No other adverse patient effects were reported.Patient's weight added.Patient's relevant medical history added.Patient and device codes updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK
• 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: 6693107
• MDR Text Key: 79272527
• Report Number: 2025587-2017-01114
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HC105
• Device Catalogue Number: HC10526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• 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: 56 YR
• Patient Weight: 80