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

Model Number PB 10

Device Problems Gradient Increase (1270); Occlusion Within Device (1423); Device Dislodged or Dislocated (2923)

Patient Problems Endocarditis (1834); Pulmonary Valve Stenosis (2024); Rupture (2208); Vascular System (Circulation), Impaired (2572)

Event Date 02/25/2016

Event Type  Injury  

Manufacturer Narrative

Citation: ghobrial j, aboulhosn j.Impact of right-sided-catheter-based valve implantation on decision-making in congenital heart disease.Curr cardiol rep.2016 apr;18(4):33.Doi: 10.1007/s11886-016-0712-2.Earliest date of e-publish/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 meta-analysis regarding the impact of right-sided catheter based valve implantation.All data were collected from multiple centers.The study population included an undetermined amount of patients implanted with medtronic melody transcatheter pulmonary valves (serial numbers not provided).Among all patients adverse events included: moderate stenosis, increased gradient, endocarditis, valve-in-valve implantation, pulmonary artery rupture, coronary artery compression, aortic compression, and valve embolization.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.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 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: 6641327
• MDR Text Key: 77571914
• Report Number: 2025587-2017-00971
• 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,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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: 05/31/2017
• 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): Required Intervention