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

Model Number PB 10

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Pulmonary Valve Stenosis (2024); Hemolytic Anemia (2279)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

Citation: mceachern w et al.Intravascular hemolysis as the first indication of melody valve failure.Journal of the american college of cardiology.2020 march; 75(11):2800 supplement 1.Doi: 10.1016/s0735-1097(20)33427-6.Published online march 16, 2020.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via a literature case report regarding a 15-year-old male patient with repaired tetralogy of fallot and a 20 mm pulmonary homograft who underwent transcatheter valve-in-valve implantation with a medtronic melody transcatheter pulmonary valve (serial number not provided).Prior to melody valve implant, two non-medtronic stents were implanted and post-dilated.The melody valve was noted to have been deployed in an optimal position.Immediately after valve implant, a peak-to-peak gradient of 15 mmhg was observed.At an unspecified time later, the patient presented with tea-colored urine.Initial laboratory results showed blood in the urine (4+), decreased hemoglobin (12.7 g/dl), decreased haptoglobin level, and increased lactate dehydrogenase.An echocardiogram exhibited a peak gradient of 30 mmhg with a mean of 20 mmhg.The patient was treated with intravenous hydration and was discharged three days later with resolution of hemoglobinuria.Three weeks later, the patient¿s laboratory results indicated continued mild hemolytic anemia and an echocardiogram revealed a peak gradient of 51 mmhg.Subsequently, a repeat catheterization was performed.A ¿significant¿ stenosis of the melody valve was observed with an elevated right ventricular pressure of 95 mmhg and a transvalvular gradient of 63 mmhg.Fluoroscopy showed mid-stent narrowing but did not identify any stent fractures on the valve frame.The valve was re-dilated with a 22 mm x 2 cm non-medtronic balloon with an increase in caliber of 2 mm.After the balloon dilation, it was reported that the valve frame appeared homogenous with no obvious area of narrowing and a transvalvular gradient of 4 mmhg was noted.Two months later, an echocardiogram showed a peak gradient of 27 mmhg with a mean of 16 mmhg.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• 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: 9930844
• MDR Text Key: 196449309
• Report Number: 2025587-2020-01145
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• 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: 15 YR