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 2017-09-11 for IMPELLA RP 0046-0019 manufactured by Abiomed Europe Gmbh.
[85740856]
To date the impella rp pump product and data logs have not been returned for investigative analysis. The return process from the field has begun. Pending return of the product and data logs, the only review possible has been that of the manufacturing records. There are no other complaints made against this lot of impella rp pumps for the failure mode of hemolysis. The root cause of the hemolysis can not be determined at this time. The manufacturer will continue to investigate all reasonable obtainable source information, and will file a supplemental medwatch report if they become available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85740857]
On the (b)(6), a (b)(6) year old male was admitted with back and shoulder pain. The patient was taken to the cardiac catheterization lab and a ventricular septal defect (vsd) was observed. The vsd was thought to be caused by a myocardial infarction. An impella cp was placed for support. Four days later, on the (b)(6), due to right ventricular failure, and impella rp was placed for right heart support. The patient returned to the icu and was monitored for right heart filling and given fluids. The patient's condition decompensated on the night of the (b)(6) and the team drew labs to confirm a diagnosis of hemolysis. After twenty two hours of impella rp support the pump, the rp was explanted and va- extracorporeal membrane oxygenation (ecmo) was placed due to concerns of hemolysis. On the (b)(6), the team cared for the hemolysis and proceeded with support. The patient's support continued with the va- ecmo and impella cp for ten more days. During these days of support, the patient experienced multiorgan failure, was placed on dialysis, received blood product replacement, and eventually care was withdrawn. The patient expired on the (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00071 |
| MDR Report Key | 6856311 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-11 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-10 |
| Date Mfgr Received | 2017-09-14 |
| Device Manufacturer Date | 2017-06-29 |
| Date Added to Maude | 2017-09-11 |
| 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 MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461400 |
| Manufacturer G1 | ABIOMED INC. |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | PUMP, BLOOD,CARDIOPULMONARY BYPASS NON-ROLLER TYPE |
| Product Code | OJE |
| Date Received | 2017-09-11 |
| Returned To Mfg | 2017-09-14 |
| Model Number | IMPELLA RP |
| Catalog Number | 0046-0019 |
| Lot Number | 1289242 |
| Device Expiration Date | 2019-05-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-09-11 |