FDA Adverse Event
Injury
Summary report: N
COREVALVE
MDR report key: 3625172
·
Received February 12, 2014
Report
- Report Number
- 2025587-2014-00033
- Event Type
- Injury
- Date Received
- February 12, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 27, 2014
- Manufacturer
- MEDTRONIC COREVALVE LLC
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED. CONCLUSION: CONDUCTION DISTURBANCES ARE A KNOWN POTENTIAL ADVERSE EFFECT AS DOCUMENTED IN THE COREVALVE INSTRUCTIONS FOR USE (IFU), AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER. (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 2 DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, NEW ONSET LEFT BUNDLE BRANCH BLOCK (LBBB) WAS NOTED. INTERMITTENT COMPLETE HEART BLOCK (CHB) WAS NOTED 3 DAYS POST-IMPLANT. SUBSEQUENTLY, A PERMANENT PACEMAKER WAS IMPLANTED ONE WEEK POST VALVE IMPLANT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93467 | COREVALVE | HEART-VALVE, NON-ALLOGRAFT TISSUE | NPT | MEDTRONIC COREVALVE LLC | MCS-P3-3143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention |