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

Model Number PB 10

Device Problems Fracture (1260); Occlusion Within Device (1423); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Material Distortion (2977); Torn Material (3024)

Patient Problems Endocarditis (1834); Hematoma (1884); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 04/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: feasibility and short-term outcomes of percutaneous transcatheter pulmonary valve replacement in small (<(><<)>30 kg) children with dysfunctional right ventricular outflow tract conduits citation: circ cardiovasc interv.2014;7:142-148 authors: darren p.Berman, md; doff b.Mcelhinney, md; julie a.Vincent, md; william e.Hellenbrand, md; evan m.Zahn, md month and year of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review that a study was performed to evaluate technical and short-term clinical outcomes of patients who underwent transcatheter pulmonary valve (tpv) replacement for treatment of conduit dysfunction.The study population included 25 patients (predominantly male, mean age 8.0 years), 23 of which were successfully implanted with a medtronic transcatheter pulmonary bioprosthetic valve (serial numbers not provided).Among all patients, one death occurred due to complications related to a left pulmonary artery laceration during angioplasty procedure; this death was not attributed to medtronic product.Other adverse events included: 2 mild regurgitation (due to paravalvular leak or distortion of the proximal portion of the tpv), 5 confined conduit tears (2 required stent placement), 1 abdominal hematoma (due to trauma during surgery and required postoperative blood transfusion), 1 guidewire induced perforation, and 5 unexpected additional vascular accesses due to mismatch between the relatively large valve delivery system and patient venous structures.During follow-up, 4 patients underwent conduit re-intervention.One patient continued to exhibit significant conduit stenosis after tpv implant and was referred for elective conduit replacement 16 months later.Two of the patients developed a clinically significant bioprosthetic valve stent fracture associated with moderate restenosis and were successfully treated with a second tpv implant 2.1 years and 7 months after initial implant.One patient underwent elective conduit replacement after medical therapy for bacterial endocarditis (the valve was functioning well with no progression of obstruction or regurgitation) 1.6 years after tpv implant.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: MELODY TRANSCATHER 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 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: 5291894
• MDR Text Key: 33344213
• Report Number: 2025587-2015-01319
• 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,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/12/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 00008 YR
• Patient Weight: 21