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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number PB1018
Device Problems Fracture (1260); Gradient Increase (1270)
Patient Problems Fatigue (1849); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Unspecified Heart Problem (4454)
Event Date 10/13/2020
Event Type  Injury  
Manufacturer Narrative
Product analysis: no product was returned. Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that approximately four years and eight months following the implant of this transcatheter pulmonary bioprosthetic valve into a previous transcatheter pulmonary bioprosthetic valve, the patient underwent catherization and electrophy siologic examination with ablation for atrial fibrillation (afib). Per the physician, the catherization and afib event were not related to the valve. During the examination, an invasive right ventricular-pulmonary artery (rv-pa) gradient of 50 millimeter of mercury (mmhg) was measured and multiple type three stent fractures of the valve and non-medtronic (cp) pre-stent were observed. No pulmonic insufficiency was reported. Four years, ten months and twelve days following the valve implant, the rv-pa gradient and decrease right ventricular function were confirmed on the follow up visit. Fatigue was reported. Four years, ten months and twenty five days following the valve implant, the patient underwent open heart surgery where the valves and pre-stents were explanted and replaced with a 25 mm medtronic conduit. Following the explant, the surgeon described one leaflet of the valve to be completed immobilized by thrombus. There were no comments made regarding the remaining leaflets. A microbial smear of the thrombosed leaflet revealed corynebacterium species. No positive blood cultures were taken before, during or after the procedure. The patient received two weeks of medication and was discharged uneventfully. No additional adverse patient effects were reported.  .
 
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Brand NameMELODY TRANSCATHETER PULMONARY VALVE
Type of DevicePULMONARY 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11397220
MDR Text Key234241195
Report Number2025587-2021-00724
Device Sequence Number1
Product Code NPV
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P140017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2016
Device Model NumberPB1018
Device Catalogue NumberPB1018
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2021 Patient Sequence Number: 1
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