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 2018-01-04 for IMPELLA RP 0046-0019 manufactured by Abiomed Europe Gmbh.
[96353287]
The impella rp was returned for investigation. The struts of the outflow cage were found to have failed at the solder joint between the strut and ball of the outflow cage. According to the physician, the patient's iliac vein was "very tortuous. " the damage to the struts on the outflow cage may have occurred while the pump was passing through the introducer, which had kinked due to the iliac tortuosity. The root cause of the pump damage is likely delivery through the kinked introducer as a result of the iliac tortuosity, however this cannot be confirmed. Therefore, the vascular perforation was likely caused by the damaged struts of the outflow cage, however this cannot be confirmed. A review of the device history did not reveal any abnormalities. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96353288]
An (b)(6) year old male patient presented to the cardiac cath lab post-cabg and with decreasing cardiac index. The decision was made to implant an impella rp for support. The patient's iliac vein was noted to be very tortuous according to the implanting physician. As the physician attempted to manipulate the pump into place, the peel away introducer was damaged, and the catheter portion of pump exited the side of the damaged introducer and perforated the patient's iliac vein. The patient's vein was surgically repaired with covered stents and blood replacement products were given. The decision was made to abort the placement of the impella rp as the patient's condition had improved to the point where there was no immediate need for other support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2017-00121 |
| MDR Report Key | 7163853 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-04 |
| Date of Report | 2017-12-08 |
| Date of Event | 2017-12-08 |
| Date Mfgr Received | 2017-12-08 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2018-01-04 |
| 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 G1 | ABIOMED EUROPE GMBH |
| Manufacturer Street | NEUENHOFER WEG 3 |
| Manufacturer City | AACHEN, 52074 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52074 |
| 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 | 2018-01-04 |
| Returned To Mfg | 2017-12-19 |
| Model Number | IMPELLA RP |
| Catalog Number | 0046-0019 |
| Lot Number | 1282657 |
| Device Expiration Date | 2019-03-31 |
| 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 52074 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-04 |