MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-12-19 for IMPELLA RP 0046-0011 manufactured by Abiomed Europe Gmbh.
[95248794]
The impella cp pump product and data logs were returned for analysis, however the investigation is on-going at this time. A supplemental medwatch will be completed upon investigation completion. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95248795]
Italian complainant reported that on (b)(6) 2017 an impella rp was placed in a (b)(6) female patient. The patient was reported to have been successfully supported, per the case information relayed through european distributor. On (b)(6) 2017, day 9 of patient support, the patient was weaned from the rp device. The physician tried to remove the device, but damaged the catheter in his attempt and fractured it into two pieces during removal. As a result, the detached portion of the cannula and pump remained in the patient's iliac vein, which necessitated surgical removal of the portion of the cannula. The detached portion of the device was successfully removed from the iliac vein. The patient was reported to be in cardiogenic shock during the surgical removal of the device. An ecmo was placed in the patient for hemodynamic and respiratory support subsequent to impella rp explant. The patient was reported to be in critical condition. There was no additional information available regarding the patient's condition.
Patient Sequence No: 1, Text Type: D, B5
[117331231]
The impella rp was returned for evaluation, with the cannula detached from the motor housing. During the evaluation the silicone was found over the delo bead that was lined up with the differential pressure sensor, and the hydex ring was deformed. While the particular circumstances of this failure is unknown, silicone contamination and deformation of the hydex ring is known to reduce the strength of the pump housing/cannula bond. This could predispose it to failure under the stress applied during pump explant. In this instance is not clear whether the hydex ring deformation occurred prior to the intervention to extract the cannula from the patient's iliac vein. (b)(4) was created to address rp cannula detachments. In conclusion the root cause of the cannula detachment was unable to be determined, but silicone contamination may have contributed to the failure. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220648-2017-00118 |
| MDR Report Key | 7129778 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-12-19 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-01-17 |
| Device Manufacturer Date | 2017-03-09 |
| Date Added to Maude | 2017-12-19 |
| 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 | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2017-12-19 |
| Returned To Mfg | 2017-12-15 |
| Model Number | IMPELLA RP |
| Catalog Number | 0046-0011 |
| Lot Number | 1273471 |
| Device Expiration Date | 2018-10-31 |
| 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, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-19 |