FDA Adverse Event
Malfunction
Summary report: N
IMPELLA 5.5
MDR report key: 17958408
·
Received October 18, 2023
Report
- Report Number
- 1220648-2023-04153
- Event Type
- Malfunction
- Date Received
- October 18, 2023
- Date of Event
- January 28, 2022
- Report Date
- October 18, 2023
- Manufacturer
- ABIOMED, INC.
- Product Code
- OZD
- UDI-DI
- 00813502011531
- PMA / PMN Number
- P140003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION INTO THE REPORTED LOW PUMP FLOWS WAS COMPLETED. THE DEVICE WAS RETURNED FOR EVALUATION. EVALUATION OF THE RETURNED PUMP FOUND A CLOT AROUND THE IMPELLER. THE ROOT CAUSE OF THE LOW FLOWS WAS INGESTED BIOMATERIAL. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT A 62-YEAR-OLD MALE PATIENT IMPLANTED WITH THE IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT EXPERIENCED LOW PUMP FLOWS DUE TO A CLOT. THE PUMP WAS SUBSEQUENTLY EXCHANGED WITHOUT ISSUE. OF NOTE, THE PATIENT'S PRE-OPERATIVE ACT WAS 218. 3000 UNITS OF HEPARIN WERE ADMINISTERED AND THE ACT AFTER INSERTION INCREASED TO 287. THERE WAS NO REPORTED HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618505 | IMPELLA 5.5 | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP | OZD | ABIOMED, INC. | IMPELLA 5.5 | 2022155800 | 00813502011531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male |