FDA Adverse Event
Injury
Summary report: N
IMPELLA RP
MDR report key: 17537322
·
Received August 12, 2023
Report
- Report Number
- MW5144201
- Event Type
- Injury
- Date Received
- August 12, 2023
- Report Date
- April 5, 2019
- Manufacturer
- ABIOMED
- Product Code
- OJE
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MEDTRONIC RECEIVED INFORMATION THAT DURING REMOVAL OF THE LMPELLA RP DEVICE FROM THE HEMOSTATIC SHEATH IN RIGHT GROIN, A THROMBUS WAS NOTED WITH THIS ASSOCIATED DEVICE. THE THROMBUS WAS MECHANICALLY EVACUATED WITH SEQUELAE AND THE DEVICE WAS SUCCESSFULLY REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785113 | IMPELLA RP | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE | OJE | ABIOMED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |