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

Model Number PB 10

Device Problems Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problems Hematoma (1884); Pulmonary Valve Stenosis (2024)

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

Citation: shahanavaz s et al.Intentional fracture of bioprosthetic valve frames in patients undergoing valve-in-valve transcatheter pulmonary valve replacement.Circ cardiovasc interv.2018 aug 3;11(8):e006453.Doi: 10.1161/circinterventions.118.006453.Earliest date of publish used for event date in b3.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 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 literature regarding an effort to identify patient-related, valve-related, or technical factors associated with outcomes of attempted intentional bioprosthetic valve frame fracture in patients who underwent transcatheter valve-in-valve replacement in the pulmonary position.All data were retrospectively collected from 13 centers.The study population included 37 patients with a mean age of 21 years.Of those, 28 were identified as having been implanted with medtronic melody transcatheter pulmonary valves and 3 were previously implanted with medtronic mosaic bioprosthetic valves in the pulmonary position.No serial numbers were provided.Among all mosaic patients, adverse events included: bioprosthetic pulmonary valve dysfunction that required transcatheter valve-in-valve implantation.No other details were reported.Based on the available information, medtronic product was associated with the adverse events.Among all melody patients, adverse events included: valve malposition, residual pulmonary valve stenosis, and a pre-stent dislodged and embolized into the main pulmonary artery during advancement of the melody delivery catheter system that required surgical removal of the pre-stent and valve replacement.Other adverse events observed: retroperitoneal hematoma that required hospitalization and blood transfusion.It was noted that there was no evidence of active bleeding from the vascular access sites related to the retroperitoneal hematoma.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Device code c63043 was incorrectly submitted on the initial report for the melody device.Device code c63043 was resubmitted on a supplemental report for the ensemble delivery catheter system device.Reference report number below.Mfr report number: 2025587-2019-03914 follow up number: 001.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9531440
• MDR Text Key: 185034114
• Report Number: 2025587-2019-03915
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• 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
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR