MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-12 for IMPELLA RP SET IMPELLA RP PUMP 004334 manufactured by Abiomed Europe Gmbh.
[75089744]
The impella rp was returned to this manufacturer for evaluation. A visual examination of the device was performed. The catheter was found to have been cut, and biomaterial was found to be wrapped around the proximal end of the impeller. The pump housing was removed and was soaked in tergazyme to remove dried blood and biomaterial. No defects were found on the pump housing surface. Since it was also indicated that a clot was found in the right atrium, the biomaterial on the pump was most likely ingested and did not build up over time. The biomaterial could have been ingested by the pump when it was running or during explant. A review of the device history record showed no other devices from this lot with this or any other failure mode. In conclusion, the root cause of the hemolysis was unable to be determined, as the catheter had been cut and the console data logs were not returned for analysis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75089745]
The complainant reported that on (b)(6) 2017 a (b)(6) patient was taken to the operating room for the placement of a heartmate ii left ventricle assist device (lvad. ) following placement of the lvad the patient's right ventricle struggled to come off the heart lung pump. As a result the impella rp was placed. The pump was placed with ease, and was in good position with the pig tail deflected into the patient's left pulmonary artery (lpa), as confirmed with x-ray. The following day the intra-aortic balloon pump (iabp) was removed the patient continued to be successfully supported with the impella rp and the lvad. On (b)(6) 2017 the patient's chest was opened. Heparin levels were reduced slightly due to bleeding concerns after the patient's chest was opened, and the activated clotting time (act) fell from recommended levels to 157. The patient's chest was closed on (b)(6) 2017; the act was at 151. The impella rp placement was verified via chest x-ray with no reported issues. The lvad remained in place. Heparin was confirmed to be in the purge fluid, and the patient remained on epinephrine, milrinone and vasopressin. On (b)(6) 2017 a clot in the patient's right atrium was found during an echocardiogram. The patient was taken to surgery where the initial intervention to remove the clot with an angiovac was unsuccessful. Clots external to the heart were washed out. It was noted by the physician that the rp was doing almost all of the work for the patient's right heart during the procedure. Heparin in the purge fluid was changed to argatroban as there were heparin-induced thrombocytopenia (hit) concerns. Following this procedure the patient was taken to the icu without event. On (b)(6) 2017 an increase in hematuria had been noted since the previous day, both the impella rp and the lvad were still in place. The patient hemoglobin lab results showed the pfhgb to be at 460. The patient was successfully weaned and the impella rp was removed from the patient. The impella rp pump was found to have clot at the inflow cage upon explant. No blood products were administered to the patient and no dialysis was performed as a result of the reported hematuria, and patient's impella 5. 6 days of impella rp support was reported as successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00032 |
| MDR Report Key | 6565177 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-12 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-04-11 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2017-05-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RALPH BARISANO |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9788828068 |
| Manufacturer G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN 52074, GM, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP SET |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2017-05-12 |
| Returned To Mfg | 2017-04-13 |
| Model Number | IMPELLA RP PUMP |
| Catalog Number | 004334 |
| Lot Number | 1261980 |
| Device Expiration Date | 2018-08-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE GMBH |
| Manufacturer Address | NEUENHOFER WEG 3 AACHEN 52074, GM, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-12 |