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

Model Number PB1018

Device Problem Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 10/30/2014

Event Type  Injury  

Event Description

Medtronic received information from a medical journal article that an unspecified surgical re-intervention was required at 24 months post-implant for a patient whose transcatheter pulmonary valve (tpv) experienced conduit obstruction.The article contained no additional information regarding the device, the device issue or outcome.The information was reported from a multi-center retrospective study of 64 patients over a 32-month period.The article reported a 100% success rate for initial implants.

Manufacturer Narrative

This patient was one of three cited in the article who experienced a post-implant intervention; separate reports have been filed for the other two patients and issues reported in the article.Without device-identifying information, a review for device history or return could not be conducted.Additional information is being sought from the article¿s author contact.(b)(6).Article: melody transcatheter pulmonary valve implantation: results from a french registry authors: alain fraisse, philippe aldebert, sophie malekzadeh-milanib, jean-benoit thambod, jean-francois piéchaud, pascaline aucoururier, gilles chatelier, damien bonnet, laurence iserin, béatrice bonello, anass assaidi, issam kammache, younes boudjemline.Archives of cardiovascular disease (2014) 107, 607¿614 dx.Doi.Org/10.1016/j.Acvd.2014.10.001.

Manufacturer Narrative

To date, additional information has not been obtained from the article¿s authors.Stenosis, regurgitation, bleeding, hematoma and pseudoaneurysm are known adverse events.Based on the available information, it is unknown if the device cause or contributed to the clinical observation.A supplemental report will be filed if additional information is obtained.

Manufacturer Narrative

The article's author contact subsequently reported the tpv was replaced with a homograft.No additional information was provided regarding the device's serial number or the cause of its obstruction.

• Brand Name: MELODY TRANSCATHER PULMONARY
• 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: 4488316
• MDR Text Key: 5345195
• Report Number: 2025587-2015-00133
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• 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): Required Intervention