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.

• 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: 9531440
• MDR Text Key: 185034114
• Report Number: 2025587-2019-03915
• 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

• 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

• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/30/2019 Patient Sequence Number: 1