MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB1018

Device Problems Fracture (1260); Occlusion Within Device (1423); Structural Problem (2506)

Patient Problems Pulmonary Regurgitation (2023); Thrombus (2101); Stenosis (2263)

Event Date 02/24/2014

Event Type  Injury  

Manufacturer Narrative

Additional information was received that 35 months post-implant, wide complex ventricular tachycardia (vt) was noted via electrocardiogram (ecg) after symptoms of a fast heartbeat during exercise.Cardioversion was performed successfully, however short bursts of vt continued until an implantable cardioverter defibrillator (icd) was implanted the same day of the valve explant.No adverse patient effects were reported.Conclusion: conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or c atheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manuf acturing issue.(b)(4).

Event Description

Medtronic received information that three years post implant of this transcatheter pulmonary bioprosthetic valve, mixed stenosis and regurgitation was observed.A type one fracture was noted under fluoroscopy.The stent appeared more oval shaped compared to previous fluoroscopy images.The valve and previously implanted 20mm contegra conduit were surgically removed due to the patient's increased in size with age (the contegra conduit would not dilate beyond the 20 mm size), a new non-medtronic 27mm surgical valve was implanted.No adverse patient effects were reported.The transcatheter bioprosthetic valve will be returned for analysis.

Manufacturer Narrative

The product has not been returned for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Should the product be returned, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the device appeared to have been cut into two pieces longitudinally through two leaflets.An unknown bare metal stent this device appeared to have been deployed within remained attached to the melody valve.Due to the receipt condition of the device, the reported stent fracture and oval shape could not be verified.All leaflets were slightly stiff but flexible.Cuts on the existing leaflets appeared to have occurred during explant.Two commissures were intact.Glistening off-white pannus lined the outflow orifice, extending approximately 1 to 5 mm into the inner lumen.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Reduced performance of the valve was attributed to host tissue overgrowth (pannus).This finding is generally considered a patient-related condition.

Manufacturer Narrative

Additional information was received from the pathology report that there was a small amount of thrombus on the cusps of the valve.No adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: the pathology analysis reported thrombus.Thrombus could cause the immobile leaflet and lead to stenosis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MELODY TRANSCATHER PULMONARY
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: 3687668
• MDR Text Key: 12544936
• Report Number: 2025587-2014-00133
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2013
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2011
• 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: 00017 YR
• Patient Weight: 46