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

Model Number PB 10

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Citation: kerst et al.Intervention: murphy¿s law in the cath lab: tuning a disharmonic melody into a harmonic pulmonary and tricuspid concert.Cardiology in the young: volume 26, supplement 1, pages s1¿s181.50th annual meeting of the association for european paediatric and congenital cardiology (aepc).Rome, italy.June 1-4, 2016.Doi:10.1017/s1047951116000500.Earliest date of publish used for date of event.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 a (b)(6) year-old male patient with severe right heart failure caused by severe stenosis of the surgically implanted pulmonary homograft.The patient underwent a procedure to implant a medtronic melody bioprosthetic valve delivered by the ensemble catheter system (unique device identifier numbers not provided).Following preparation of the pulmonary ¿landing zone¿ with placement of three non-medtronic stents, the ensemble delivery catheter with the pre-mounted melody valve could not be advanced to the targeted pulmonary position.Eventually, several troubleshooting methods resulted in the access and successful placement of two melody valves.The first melody valve was balloon expanded into a funnel-like shape followed by successful placement of a second melody valve yielding ¿two melodies in harmonic concert¿ per the physician/authors.No additional adverse patient effects or product performance issues were reported.The exact positioning of the two melody valves was not stated, however the description suggests a valve-in-valve placement.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12436648
• MDR Text Key: 270290652
• Report Number: 2025587-2021-02755
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• 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: 08/24/2021
• 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: 28 YR