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); Device Dislodged or Dislocated (2923)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Left Ventricular Failure (1948); Ventricular Tachycardia (2132); Rupture (2208); Stenosis (2263); Complete Heart Block (2627); Vascular Dissection (3160)

Event Date 07/01/2018

Event Type  Injury  

Manufacturer Narrative

Citation: arboleda salazar r anesthesia for percutaneous pulmonary valve implantation: a case series.Anesth analg.2018 jul;127(1):39-45.Doi: 10.1213/ane.0000000000002904.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 anesthesia for percutaneous pulmonary valve implantation.All data were collected retrospectively from a single center between july 2006 to december 2015.The study population included 79 patients (predominantly male, median age 43 years), 50 of which were implanted with medtronic melody transcatheter pulmonary valve.No serial numbers were provided.The literature also included a meta-analysis secondary review of primary data from 7 additional articles in which 771 patients were implanted with melody transcatheter pulmonary valve.No patient demographics or device serial numbers were provided with regards to this meta-analysis.Among all patients, procedural mortality was reported to be 1.6% in the meta-analysis review.However, based on the available information, there was no evidence to suggest that the valve or its function contributed to these deaths.Among all patients, adverse events included: right ventricular outflow tract (rvot) and pulmonary artery (pa) tear and rupture, valve embolization, coronary artery dissection/compression, increased gradient, ventricular tachycardia requiring cardioversion, right bundle branch block (rbbb), third degree atrio-ventricular (av) block, and left ventricle dysfunction.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between medtronic product and the observed adverse events.Among all patients, access site adverse events included femoral vein hematoma complicated by infection and pseudoaneurysm.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between medtronic product and the observed malfunction.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: 7995078
• MDR Text Key: 124697915
• Report Number: 2025587-2018-02814
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• 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: 10/12/2018
• 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: 43 YR