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

Model Number PB 10

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Endocarditis (1834); Stenosis (2263); Low Cardiac Output (2501)

Event Date 02/01/2011

Event Type  Injury  

Manufacturer Narrative

Citation: lurz p et al.Early versus late functional outcome after successful percutaneous pulmonary valve implantation: are the acute effects of altered right ventricular loading all we can expect- j am coll cardiol.2011 feb 8;57(6):724-31.Doi: 10.1016/j.Jacc.2010.07.056.Epub 2011 feb 1.Earliest date of publish used for event date.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 the 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 the potential of late positive functional remodeling after percutaneous pulmonary valve implantation (ppvi) in right ventricular outflow tract dysfunction.All data were collected from a single center between may 2004 and june 2008.The study population included a total of 107 patients, however, only 65 met inclusion criteria (predominantly male; mean age 20 years), all of which were implanted with a medtronic melody transcatheter pulmonary valve.No serial numbers were provided.Among all 107 patients, one sudden death occurred.Based on the available information, medtronic product did not cause or contribute to this death.Among all 107 patients, adverse events included: valve-in-valve ppvi due to early restenosis, valve explantation due to endocarditis, rescue open-heart surgery, restenosis as defined by an increase in right ventricular outflow tract gradient - 15 mm hg, low left ventricular ejection fraction, and low right ventricular ejection fraction.Based on the available information, medtronic product may have caused or contributed to these 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: 8145133
• MDR Text Key: 129746204
• Report Number: 2025587-2018-03349
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2018
• 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: 11/18/2018
• 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
• Patient Age: 20 YR