FDA Adverse Event
Malfunction
Summary report: N
MELODY TRANSCATHER PULMONARY
MDR report key: 4121527
·
Received September 26, 2014
Report
- Report Number
- 2025587-2014-00701
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- June 23, 2008
- Report Date
- September 4, 2014
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPV
- PMA / PMN Number
- H080002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED OR THE PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT OVER 6 YEARS POST IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), A MINOR STENT FRACTURE (TYPE 1) WAS NOTED. IT WAS REPORTED THAT NO INTERVENTION HAS BEEN REQUIRED AND THE VALVE REMAINS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602052 | MELODY TRANSCATHER PULMONARY | PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED | NPV | MEDTRONIC HEART VALVES DIVISION | PB10F18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00019 YR | Other |