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 2020-03-12 for IMPELLA CP PUMP IMPELLA CP PUMP SET, JAPAN 0048-0034-JP manufactured by Abiomed, Inc..
[183236580]
The impella cp was discarded by the customer and therefore, investigation of device was not possible. Should any new information be returned, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183236581]
The complainant reported a (b)(6) female patient had impella cp pump inserted in the right femoral for unloading left ventricle. It was reported the patient was rushed to the emergency room for unexplained severe heart failure or cardiogenic shock. The physician stated insertion was difficult due to a strong resistance and during the insertion dissection of the abdominal aorta occurred. The physician stated the cause of the abdominal dissection is unknown as it could have been cause by percutaneous cardiopulmonary support (pcps) or the impella device. The patient ultimately expired due to aortic dissection and cardiac tamponade. The physician stated the relationship between the device and death is unknown as he was unable to determine if the cause of the cardiac tamponade was due to aortic dissection or cardiac rupture due to thin ventricular walls. It is also unknown whether the patients ruptured heart was cause by the impella or by the patient's blood pressure jumping to 200 when the adrenaline was administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2020-00375 |
| MDR Report Key | 9826694 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-12 |
| Date Facility Aware | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-12-26 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 DR |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer G1 | ABIOMED, INC. |
| Manufacturer Street | 22 CHERRY HILL DR |
| 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 CP PUMP |
| Generic Name | TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP |
| Product Code | OZD |
| Date Received | 2020-03-12 |
| Model Number | IMPELLA CP PUMP SET, JAPAN |
| Catalog Number | 0048-0034-JP |
| Lot Number | 1453032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-12 |