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 2018-07-20 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[114602947]
The device was returned to abiomed for evaluation. The catheter was found to have been cut, which was done by the clinicians to maintain access for va ecmo insertion after the impella rp was explanted. This disallowed the ability to perform hemolysis testing of the returned impella rp. A thrombus was noted to be inside the pump housing on the impeller, but no other defects were found on the pump. The automatic impella controller's data logs were returned for this case. The analysis of the logs revealed that the pump had been run for a total of about 12 hours. There were no alarms that triggered related to the failure mode throughout patient support. There was elevated and changing placement signals throughout, which could correlate with the biomaterial ingestion. The changes in the placement signal and motor current during support indicated either changing position or interaction with patient vasculature or ingested biomaterial during this time. A review of the device history record revealed that there had been no issues found during the manufacture or inspection of the device that apply to this failure mode. In addition, there have been on complaints reported related to this failure mode. The root cause of the hemolysis was most likely thrombus ingestion, but this could not be definitively determined as hemolysis testing could not be completed on the pump. No corrective action is recommended at this time as the root cause of the hemolysis was unable to be definitively determined. Failures of this type will continue to be monitored for trends.
Patient Sequence No: 1, Text Type: N, H10
[114602948]
On (b)(6) 2018 a (b)(6) year old male patient with post-cardiotomy cardiogenic shock had post aortic valve replacement surgery. The valve replacement surgery was difficult, and a va ecmo device was placed urgently. The ecmo was decannulated after supporting the patient for 24 hours, the patient was administered 2 units of packed red blood cells and an impella rp was placed in the patient. The physician did not use echo to evaluate for clotting prior to the rp insertion. It was reported that there was heparin in the purge solution from implant, but not systemically administered due to bleeding from the ecmo insertion site. During the night patient hemolysis occurred. The labs continued to indicate hemolysis, and the patient's urine output was black. Under x-ray the pump appeared to be located just below the pulmonic valve. The staff was unable to get the heparin level up due to the hemolysis. The impella rp was unable to be repositioned, and on (b)(6) 2018 the impella rp was removed and a va ecmo was placed in the patient. Patient care was withdrawn on (b)(6) 2018 and subsequently expired on that same date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00073 |
| MDR Report Key | 7707061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-20 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-06-22 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-07-20 |
| 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 |
| Generic Name | TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-07-20 |
| Returned To Mfg | 2018-06-28 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1301336 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| 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. Death; 2. Required No Informationntervention | 2018-07-20 |