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 2018-04-18 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[105848613]
The facility did not return the impella rp product for investigation. The data logs were returned for analysis. The root cause of the tear to the ivc was unable to be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105848614]
An (b)(6) male was admitted with cardiogenic shock and had an aortic valve repair (avr) and right coronary artery repair. Post operatively an impella rp was placed. The placement of the rp was difficult due to tortuous pulmonary arteries. After four days of support the patient was deteriorating and he was treated for a hemothorax. The next day he was taken to the operating room where they were unable to determine the source of the bleeding. As his condition was not improving, the patient had his impella explanted. For a cannulation of ecmo. He required blood products (approximately 50 units), the abdomen was distended, and the medical team observed a tear to the inferior vena cava. The cause of the tear is not known. The family chose to withdraw care, and he expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00028 |
| MDR Report Key | 7440418 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-18 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-03-29 |
| Device Manufacturer Date | 2017-12-14 |
| Date Added to Maude | 2018-04-18 |
| 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 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 | TEMPORARY NON ROLLER RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-04-18 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1314718 |
| Device Expiration Date | 2019-11-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-04-18 |