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); Structural Problem (2506); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Mitral Regurgitation (1964); Thrombus (2101); Obstruction/Occlusion (2422); Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

Citation: hu, j.Md et al.Transcatheter mitral valve implantation for degenerated mitral bioprostheses or failed surgical annuloplasty rings: a systematic review and meta-analysis.Journal of cardiac surgery.Sep;33(9):508-519 epub 2018 jul 10.Doi 10.1111/jocs.13767.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via a meta-analysis literature review regarding the implant of transcatheter bioprosthetic valves implanted into failed mitral valves and rings.All data were collected from a pubmed search of articles published between 2000 and march 2018.Sixty-six articles were identified.The overall population included 245 patients.Eighteen patients were implanted with a melody transcatheter bioprosthetic pulmonary valve, implanted in the mitral position.The remaining patients were implanted with a non-medtronic transcatheter bioprosthetic valve.It was reported that the both mosaic and hancock mitral valves had been replaced during the valve-in-valve implants.Serial numbers were not provided.The study population was predominantly male; mean age 73 ± 12.1 years.Among all patients, no deaths were attributed to a medtronic product.Among all patients implanted with a transcatheter pulmonary valve implanted into the mitral position, adverse events included: valve migration, left ventricular outflow tract (lvot) obstruction, greater than mild mitral regurgitation, blood loss, thrombus, pseudoaneurysm, cerebral vascular accident (cva), arrythmia treated with implantable cardioverter defibrillator (icd), increased mean gradients, leaflet thickening/reduced leaflet motion, and atrial septal defect treated with closure.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the medtronic product.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: 8220686
• MDR Text Key: 132202415
• Report Number: 2025587-2019-00082
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2019
• 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: 12/11/2018
• 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: 73 YR