MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-26 for IMPELLA RP IMPELLA RP EU 0046-0011 manufactured by Abiomed Europe Gmbh.
[182698386]
The investigation into the vessel dissection that necessitated blood products and stenting is on-going at this time. Upon completion of the investigation, a final report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182698387]
The medical team in (b)(6) had a male patient in need of both right and left ventricular support. The patient was suffering from biventricular heart failure with influenza, myocarditis, and cardiomyopathy. The team had an access site complication when placing the impella rp for the right ventricular support. There was a femoral vein perforation that was treated with a covered stent of approximately 7cm, and blood products were infused. Once stented, the patient was placed on support with the impella successfully. Both the rp and impella cp were placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00353 |
| MDR Report Key | 9758808 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-31 |
| Date Facility Aware | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2018-12-06 |
| Date Added to Maude | 2020-02-26 |
| 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 | TEMPORAY NONROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-13 |
| Model Number | IMPELLA RP EU |
| Catalog Number | 0046-0011 |
| Lot Number | 1378760 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-02-26 |