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 2018-04-11 for IMPELLA RP 004334 manufactured by Abiomed, Inc..
[105148541]
There is no known malfunction that we are aware of, however neither the pump nor the introducer was returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[105148542]
An impella rp was placed for support for right ventricular failure, post-pulmonary embolism and pulmonary hypertension on (b)(6). While the clinical team was removing the 23 x 30 peel away sheath, a mattress suture was placed; however it was not sufficient to maintain hemostasis. A second mattress was placed and femostop was applied. Upon arrival to cvicu, there was still continuous bleeding from the right femoral vein. The patient was brought to the operating room for repair of the vasculature and removal of the impella rp. The patient was then returned to the cvicu where she continued to bleed, requiring the administration of a blood transfusion. The patient went into pulseless electrical activity (pea) and arrested. Cpr was performed however the patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00020 |
| MDR Report Key | 7421463 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-11 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-03-15 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2018-04-11 |
| 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 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 | 2018-04-11 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1311325 |
| Device Expiration Date | 2019-10-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DRIVE DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit | 2018-04-11 |