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 2016-04-15 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[42848948]
A definitive root cause of the damage to the mitral valve could not be determined. The pump was discarded after the case and consequently unavailable for analysis. The exact cause could not be determined from the available data. According to reports from the site the positioning of the device was incorrect per the manufacturers' instructions, and the device was running while removing it from the heart, which is not per the manufacturers' instructions. Device discarded by complainant facility.
Patient Sequence No: 1, Text Type: N, H10
[42848949]
The complainant reported that a hypotensive (b)(6) male patient who had been in gi distress for the past 10 days was admitted to the hospital. The patient had no past medical history. The patient was found to have an ejection fraction of 30-35% of unknown etiology. The patient was being managed on pressor support. The patient decompensated which resulted in intubation and mechanical support. The impella cp was placed in the patient without issue; the coronaries were not visualized during placement. The patient was then transferred to another facility for continued management and the potential need for escalation of support. The patient was reported to have been successfully supported and had "greatly improved. " his ejection fraction had improved to 50%, and weaning was begun. After 4 days of pump support the impella cp was removed from the patient. The removal was reported as smooth with no resistance met. There was also no obvious "tissue" debris noted on the inlet cage or catheter apparatus following pump removal. Two days post explant, the patient became critically unstable requiring reintubation. An echo was performed which revealed a flail posterior mitral valve leaflet and severe mitral regurgitation, which necessitated surgical mitral valve repair. The patient was referred for emergent mitral valve repair. The repair was reported as successful and the patient was released from the hospital a week later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00005 |
| MDR Report Key | 5583096 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-15 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-02-18 |
| Date Facility Aware | 2016-03-18 |
| Report Date | 2016-03-18 |
| Date Reported to Mfgr | 2016-03-18 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 2015-02-26 |
| Date Added to Maude | 2016-04-15 |
| 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. WILLIAM BOLT |
| Manufacturer Street | 22 CHERRY HILL DRIVE |
| Manufacturer City | DANVERS MA 01923 |
| Manufacturer Country | US |
| Manufacturer Postal | 01923 |
| Manufacturer Phone | 9786461451 |
| Manufacturer G1 | ABIOMED EUROPE, GMBH (GERMANY) |
| Manufacturer Street | NEUEHOFER WEG 3 |
| Manufacturer City | AACHEN, GERMANY 13059, GM |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 13059, GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA CP |
| Generic Name | IMPELLA CP |
| Product Code | PBL |
| Date Received | 2016-04-15 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1182559 |
| Device Expiration Date | 2017-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE, GMBH (GERMANY) |
| Manufacturer Address | NEUEHOFER WEG 3 AACHEN, GERMANY 13059, GM GM 13059, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-15 |