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

Model Number PB10F18

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Unspecified Infection (1930); Stenosis (2263)

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

Additional information was received that 7 years post-implant of this transcatheter pulmonary valve (tpv) implanted valve-in-valve within a previous tpv, a chest x-ray indicated a small fragment of fractured stent in the posterior medial left lower lobe pulmonary artery.It was reported that this patient had multiple fractured palmetto stents in place, as well a possible stent fracture in the first tpv; clear visual confirmation could not be made to determine which stent/tpv fragment migrated.No intervention was required.No adverse patient effects were reported.A separate report will be filed on the other tpv implanted in this patient, as it is unclear from which device the fragment originated.(b)(4).

Event Description

Medtronic received information that five years and seven months post implant, the patient presented with symptoms of fever, malaise, chills and muscle aches.The patient was admitted to the hospital for possible endocarditis.The patient was monitored and a series of blood work and multiple blood cultures will be obtained.Antibiotics were administered and a transesophageal echocardiogram (tee) was performed to visualize the melody valve.Subsequently it was reported that blood cultures grew streptococcus mitis.The tee showed no evidence of vegetation.The condition was treated and resolved with medication.Two years later (seven years post implant), an echocardiogram showed evidence of an increase in right ventricular hypertension due to a gradual increase in right ventricular outflow tract stenosis.Angiography revealed significant obstruction with a proximal aspect of a previously-placed valve of this same model (implanted 1 year prior) and mild stenosis of the proximal right pulmonary artery.The valve was dilated with another manufacturer's 18 mm balloon.No other adverse patient effects were reported.

Manufacturer Narrative

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.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.(b)(4).

Manufacturer Narrative

Additional information: medtronic received additional information five years and seven months post implant of this transcatheter pulmonary valve (tpv) , the patient presented with symptoms of fever, malaise, chills and muscle aches.The patient was admitted to the hospital for possible endocarditis.Antibiotics were administered and a tee was performed to visualize the tpv valve.Subsequently it was reported that blood cultures grew streptococcus mitis.A transesophageal echocardiogram (tee) showed no evidence of vegetation.The condition was treated and resolved with medication.Two years later (seven years post implant), an echocardiogram showed evidence of an increase in right ventricular hypertension due to a gradual increase in right ventricular outflow tract stenosis.Angiography revealed a significant obstruction within the proximal aspect of the tpv (which had been implanted valve-in-valve within a previous tpv) and mild stenosis of the proximal right pulmonary artery.The physician stated angiography showed no evidence of endocarditis, and no thickening of the valve.Because there were multiple palmetto stents placed which were fractured, it was difficult to determine if the fractures were only in the stents or in both the stents and the tpv, but likely the fractures were in both.The valve was dilated with another manufacturer's 18 mm balloon which significantly lowered the gradient, however, the physician stated the patient may need replacement of the valve in the future.Of note, the valve was implanted when the patient was 13 and is now 20 years old, so has grown during that time.No other adverse patient effects were reported.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observations.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.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms such as staphylococcus and streptococcus species.The reported organism can be rendered non-viable to the sterilization process during manufacturing.Therefore, it is unlikely that the organism originally came from the device and/or manufacturing valve process.The endocarditis was treated and resolved with medication.No conclusion can be made regarding the reported high gradient/stenosis that occurred two years later.The valve was dilated with another manufacturer's 18 mm balloon.Medtronic will continue to monitor for similar events.

Manufacturer Narrative

Based on clinical data and literatures, melody stent fractures are a 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, a true root cause to the stent fractures for this event could not be determined.

Manufacturer Narrative

Conclusion: a review of the current manufacturing process controls has demonstrated that medtronic has taken appropriate steps to control contamination of products during manufacturing, including sampling of manufacturing environmental air and working surfaces, which are subsequently tested for bioburden.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms such as staphylococcus and streptococcus species.The reported organism can be rendered non-viable to the sterilization process during manufacturing.Therefore, it is unlikely that the organism originally came from the device and/or manufacturing valve process.In addition, cases that occur more than 12 months after the procedure are called late prosthetic-valve endocarditis and are largely community-acquired.At this time, it is unknown which melody device exhibited the stent fracture type iii and with no product return and limited information, no conclusion can be made.A conclusive cause of the high gradients/stenosis could not be determined from the limited information available.

Manufacturer Narrative

Additional information was received that eight years and nine months post-implant, this transcatheter pulmonary valve was explanted due to stenosis and tricuspid regurgitation.No additional adverse patient effects were reported.(b)(4).

• 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: 3928477
• MDR Text Key: 13395328
• Report Number: 2025587-2014-00459
• 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: Study,Health Professional,health professional,stu
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2008
• Device Model Number: PB10F18
• Device Catalogue Number: PB10F18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2007
• 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
• Treatment: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00021 YR