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 2018-11-27 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[128417427]
The investigation is on-going at this time. Should product or other information be shared, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[128417428]
An obese patient was admitted presenting with a 3 day old myocardial infarction, presenting as a stemi. It was determined that the patient had a septal infarct and had both right and left sided impella pumps placed. The patient "recieved" the impella rp and impella cp. In the rp access site, at the patient developed a hematoma. There was a question as too whether or not the patient's body habitus was too large and the tissue track was too deep for hemostasis by the rp repositioning sheath. The team called in vascular surgery to remedy the patient blood loss. The team achieved hemostasis and infused 3 units of blood products as well as 1 unit of platelets. Within 24 hours, the rp was explanted and the patient was solely supported by the impella cp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00144 |
| MDR Report Key | 8106117 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2018-07-10 |
| Date Added to Maude | 2018-11-27 |
| 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 |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP |
| Product Code | PYX |
| Date Received | 2018-11-27 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1348530 |
| Operator | HEALTH PROFESSIONAL |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-11-27 |