MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-14 for IMPELLA RP 004334 manufactured by Abiomed.
[139292987]
A (b)(6) y/o male on ecmo due to ischemic cardiomyopathy and acute on chronic cardiogenic shock. H/o (b)(6) and anal ca s/p xrt / chemo. Planned for insertion of lvad and impella rp. During the procedure, there was successful lvad placement. Impella rp placed under fluoroscopic guidance. For majority of procedure ventricular function remained stable with both stable rvad and lvad flows. Pt acutely decompensated following chest closure with evidence on tee of significant rv distension and lv underfilling. This coincided with low lvad flows and extremely high pi. The impella rp was emergently removed, the chest re-opened, and a surgical rvad was placed with good decompression of the left ventricle. The chest was left open with a sternal bar in place. Upon inspection of the impella rp, there was clot coating the inflow impeller. Device malfunction reported to company rep (present in operating room) and to family at conclusion of procedure. The rvad was able to be removed the following day and chest closure was performed on 02/25. The pt continues to recover in the icu.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8433146 |
| MDR Report Key | 8433146 |
| Date Received | 2019-03-14 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-21 |
| Date Facility Aware | 2019-03-13 |
| Report Date | 2019-03-13 |
| Date Reported to FDA | 2019-03-13 |
| Date Reported to Mfgr | 2019-02-21 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMPELLA RP |
| Generic Name | IMPELLA RP |
| Product Code | OJE |
| Date Received | 2019-03-14 |
| Returned To Mfg | 2019-02-21 |
| Model Number | 004334 |
| Lot Number | 21 155174 17 200229 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-14 |