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

Model Number PB10F18

Device Problem Fracture (1260)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Thrombus (2101)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the 8.4 cm conduit was received with the melody intact and in a cloudy dark red 0.2% glutaraldehyde solution.A 4.3 cm lengthwise cut was observed through the conduit.Evidence of a hemashield or patch was present.The valve was deployed within an unknown bare metal stent.All leaflets were stiff due to tan vegetative host tissue and/or mineralization on the inflow and outflow.The condition of the commissures could not be determined due to host tissue overgrowth.Pannus lined the inflow orifice and extended into the lumen to inflow margin of attachment.Pannus extended throughout the mineralization on the outflow orifice.Radiography indicated mineralization in the conduit wall.The receipt condition made it difficult to determine whether or not mineralization was present on the valve.The receipt condition and intertwining of the stents made it difficult to determine if stent fractures were present.However, the pathology report from cv path stated that the microct and radiographic imaging showed possible valve stent fractures.Based on the device history review of this product, there was no issue identified regarding manufacturing and sterilization (raw materials, manufacturing time period, packaging and labelling, or sterilization load).All devices under this sterility lot were manufactured pre approved and released manufacturing processes and the devices met all applicable manufacturing specifications prior to release for distribution.There have been two other complaints for infection against any of the devices manufactured under this sterility lot.There is no indication that the complaints are related to each other and are due to the device.The analysis of the device confirmed presence of vegetation, pannus and calcification.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms such as staphylococcus and streptococcus species.This process is validated using the worst case bacillus atrophaus (gram positive spore forming rods), which is known to be representative of the cleanroom bioburden.The granulicatella genus is known to be a normal flora of the upper respiratory, gastrointestinal and urogenital tracts of humans.Normal flora is a microorganism that normally resides at a given site and under normal circumstances does not cause disease.Therefore, it was unlikely that the organism originally came from the device and/or manufacturing valve process.In addition, the information received also indicates that the endocarditis occurred more than 7 years post implant.Endocarditis that occurs more than 12 month after the procedure are called late prosthetic-valve endocarditis and are largely community-acquired versus a result of the manufacturing process of the valve.The presumed endocarditis was unlikely to be attributed to the melody tpv device and/or manufacturing process.Event was potentially attributed to the patient¿s health status or comorbidities.A root cause to the reported purulent discharge from a pacemaker implant wound site was unknown.The pathology report from cv path stated that the microct and radiographic imaging showed possible valve stent fractures, however the fractures were unable to be confirmed due to a previous cut in the valve.Based on the received information, there were no stent fractures reported from the healthcare professional, and no stent fractures observed during the medtronic product analysis.Based on clinical data and literature, melody stent fractures are known phenomenon.Prominent mechanical stresses on the outflow tract stent, such as compression between the anterior chest wall and heart, appear to be associated with an increased risk of stent fracture.However, in this case, the pathology report cannot conclusively to confirm the stent fractures happened.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately seven years following the implant of this transcatheter pulmonary bioprosthetic valve, the patient presented to the hospital with purulent discharge which was reported to be from a pacemaker implant wound site.A blood culture was positive for granulicatella and the patient was treated with antibiotics.The valve was reported to be functioning normally but a decision was made to explant and replace the valve.No further adverse patient effects were reported.Additional information was received imaging after the valve was explanted showed possible valve stent fractures and severe calcification of the conduit.

• 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 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: 8122801
• MDR Text Key: 129016458
• Report Number: 2025587-2018-03265
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• 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: 11/30/2018

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: 07/07/2009
• Device Model Number: PB10F18
• Device Catalogue Number: PB10F18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2018
• Initial Date FDA Received: 12/01/2018
• Date Device Manufactured: 09/23/2008
• 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: 18 YR
• Patient Weight: 52