MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-23 for IMPELLA RP 0046-0011 manufactured by Abiomed Europe, Gmbh (germany).
[60842579]
The definitive root cause of the impella rp pump stop was ingestion of biomaterial. The ingested biomaterial wrapped around the impeller. The data log investigation and product testing found that spikes in motor current and high purge pressure were evident. The product was run in the lab and no pump stops occurred. This could have been due to different conditions than found in the procedure. The biomaterial was most likely interfering with the purge flow, creating the behavior/alarms seen in the case, and the eventual pumps stops. The team did not make the choice to replace the pump after experiencing the pump stops and restarting the pump. The patient expired while the va-ecmo was being setup for support. Within the ifu there are instructions on what to do upon a pump stop alarm. They are: replace white connector cable. Switch to backup controller. Replace impella catheter. The ingested biomaterial could have been due to the patient's underlying condition of a pfo and the blood shunting. The pfo and the associated shunting could have contributed to clot formation, but this is unknown. No corrective action is recommended as the failure is due to patient condition. Failures of this type will continue to be monitored and tracked. (b)(4). This mdr was one of the 13 and was originally submitted in the test environment on 10/03/2016 and the reasons stated above are the reasons it is being submitted beyond the 30 day window. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60842580]
A (b)(6) male was admitted to facility in (b)(6) with a st elevation myocardial infarction. The right coronary artery was occluded. Revascularization was attempted, however, this attempt was not successful. The patient was monitored for two days. The patient continued to deteriorate and became hemodynamically unstable, with a low blood pressure, increasing lactate levels, and an echo showing right ventricular failure. The decision was made to place an impella rp. The placement of the rp was difficult, however successful, and support was initiated. Within 30 minutes of support, the impella console did alarm for low purge flow and increased purge pressure. Troubleshooting did not reveal any kink in the pump. The team further troubleshot by exchanging the purge cassette. The alarm did not resolve, but support remained on and over the following hours the flow issue did resolve. Approximately six hours later, the rp stopped running due to high motor current. Once the rp stopped, the patient did experience severe shock with reduced oxygenation and low blood pressure. The rp was restarted and an echo was performed to observe the patient and pump function. The echo did show some movement of the rp, though the position was still across the pulmonic valve. There was evidence of massive right to left shunting (at the known pfo), poor arterial oxygenation, and rising lactic acidosis. During this time, the rp pump was flowing at 3-3. 5l/minute with almost absent pulsatility. The team chose at this time to change the therapy/support to veno-arterial (va) ecmo. Unfortunately, the patient did expire prior to the va ecmo loop being placed for support. According the physician the patient expired after the subsequent failure to restore pulmonary flow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00032 |
| MDR Report Key | 6125639 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-23 |
| Date of Report | 2016-09-06 |
| Date of Event | 2016-09-06 |
| Date Facility Aware | 2016-09-06 |
| Report Date | 2016-09-06 |
| Date Reported to Mfgr | 2016-09-06 |
| Date Mfgr Received | 2016-09-06 |
| Device Manufacturer Date | 2015-02-18 |
| Date Added to Maude | 2016-11-23 |
| 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. WILLIAM BOLT |
| Manufacturer Street | ABIOMED, INC. 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461451 |
| Manufacturer G1 | ABIOMED EUROPE, GMBH (GERMANY) |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | 52074 AACHEN, GERMANY |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2016-11-23 |
| Returned To Mfg | 2016-09-28 |
| Model Number | IMPELLA RP |
| Catalog Number | 0046-0011 |
| Lot Number | 1181611 |
| Device Expiration Date | 2016-12-18 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE, GMBH (GERMANY) |
| Manufacturer Address | NEUENHOFER WEG 3 52074 AACHEN, GERMANY 13059GM GM 13059 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-11-23 |