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 2018-05-23 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.
[109103132]
The facility did not return the impella rp product for investigation. The data logs were not returned for analysis. The root cause of the tear to the femoral artery was unable to be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109103133]
The complainant reported that the physician was treating a (b)(6) year old male post heart transplant patient who was having difficulty being weaned off the cardiopulmonary bypass machine. The patient was placed on va ecmo and pa pressure started increasing. The heart team evaluated the patient and made decision to place an impella rp and to remove the ecmo. The patient was taken to the cvor and the impella rp was placed via the right femoral artery using the 23fr sheath. The cardiothoracic surgeon de-cannulated the ecmo. The patient was reported to be bleeding following the removal of the peel away sheath, after one hour of manual compression the impella site continued to bleed; therefore the decision was made to cut down on the impella site and explorer the right femoral artery. The exploration revealed a dissection to the right femoral artery. The artery was successfully repaired. The patient remained stable and hemostasis was achieved with the surgical repair of the artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2018-00040 |
| MDR Report Key | 7539048 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-23 |
| Date of Report | 2018-04-27 |
| Date of Event | 2018-04-27 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-09-29 |
| Date Added to Maude | 2018-05-23 |
| 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 | TEMPORARY NON ROLLER RIGHT HEART SUPPORT BLOOD PUMP, |
| Product Code | PYX |
| Date Received | 2018-05-23 |
| Model Number | IMPELLA RP |
| Catalog Number | 004334 |
| Lot Number | 1302551 |
| 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, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-23 |