MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[35611616]
The impella cp was not returned for evaluation, so no device analysis could be performed. It is unclear at this time if the artery bleeding was as a result of any issue with the introducer, impella cp pump, guide-wire or if the issue occurred as a result of the patient's anatomy, device placement or the procedure that was performed. The manufacturer will continue to investigate all reasonable obtainable sources of information and will provide results and conclusions in a supplemental medwatch report if additional information is received. Device discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[35611617]
The complainant reported that a (b)(6) male patient presented with a segment elevation myocardial infarction (stemi:) resulting in an extracorporeal membrane oxygenation (ecmo) being placed in the patient. The patient also had three vessel disease (3vd) and his left ventricle was distended. The physician placed an intra-aortic balloon pump (iabp), as the patient's groin arteries were very small. The iabp did not decompress, resulting in an impella cp being placed in the patient. An antegrade sheath was also placed to provide flow down the patient's leg from the ecmo circuit. The impella cp was placed without issue in the patient. Following patient treatment, bleeding was observed to be emanating from the impella insertion site. The pump angle was adjusted, but the bleeding continued, so a femstop was applied. During patient transport a significant amount of blood was lost. The patient blood loss was reported to be in excess of 15m/l of blood per minute. A vascular repair was performed that was reported to have resolved the bleeding at the impella site. The patient was also reported to have significant bleeding from the ecmo site, and was unrelated to the bleeding from the impella pump. The patient was reported to have been administered 50 units of replacement blood, but it was reported that the replacement blood was "mostly due to the groin bleeding from the ecmo site. " the patient was reported to have been successfully supported for over 8 days with the impella cp, and was reported to be in stable condition at the conclusion of the impella cp support.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00001 |
| MDR Report Key | 5358815 |
| Date Received | 2016-01-11 |
| Date of Report | 2015-12-13 |
| Date of Event | 2015-12-13 |
| Date Facility Aware | 2015-12-13 |
| Report Date | 2015-12-13 |
| Date Reported to Mfgr | 2015-12-13 |
| Device Manufacturer Date | 2015-11-15 |
| Date Added to Maude | 2016-01-11 |
| 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 | 0 |
| Brand Name | IMPELLA CP |
| Generic Name | IMPELLA CP, PRODUCT CODE: PBL |
| Product Code | PBL |
| Date Received | 2016-01-11 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1213544 |
| Device Expiration Date | 2017-08-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 2 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 | 2016-01-11 |