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 2016-07-01 for IMPELLA IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[48675733]
The lmpella cp was not returned for evaluation, as it was discarded subsequent to the event; consequently no device analysis could be performed. It is unable to be definitively established if the arterial nick and bleeding were as a result of any issue with the introducer, lmpella cp pump, guide-wire or if the issue occurred solely as a result of the patient's anatomy. The physician reported that he believed that the large patient size prevented the repositioning sheath from providing hemostasis and the patient size also resulted in the hematoma. The console logs were returned for analysis. The logs however did not contribute any information to the root cause of this event. An examination of the event determined that the root cause of the hematoma and associated blood loss was most likely due to the patient's obesity there is therefore no corrective action to be taken. The instructions for use of the impella cp warns the user of the following: when securing the repositioning sheath, vascular closure may be difficult in obese patients with extensive adipose tissue. Before initiating the procedure, evaluate the patient for factors that may prevent successful placement of the impella catheter.... "obesity"... Is listed as one of those factors. 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. (b)(4). Device discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[48675734]
The complainant reported that the facility was treating an obese (b)(6) female patient in cardiogenic shock and who had an acute myocardial infarction. The patient had undergone an alcohol ablation while under support of an intra-aortic balloon pump (iabp). Following the ablation the patient's pressures dropped. The iabp was removed from the patient and an impella cp was placed without issue. After two arterial sticks were made access was gained femorally, and the cp was inserted via the second stick site. Impella support was initiated and the oscor sheath was removed and the repositioning sheath was placed. The physician noted patient's size and fat tissue dissuaded the peel away sheath from stopping any blood loss at the second arterial stick site. Following 2 hours of successful impella support a hematoma developed on the patient's impella side and the patient's hemaglobin level had dropped from 11. 8 to 5. 3. The patient was then taken to the operating room for evacuation of the hematoma and exploration. During this procedure the physician found a nick in the patient's artery at the location of the first stick site. The site was oozing and the artery was closed with a suture. The surgeon then closed the surgical wound site and the patient was administered three units of blood product. The impella cannula was repositioned under echo guidance and impella cp support continued. Over the following 3 days of impella cp support the patient's hemoglobin rose to 9. 4. After being successfully supported for over 2 days the impella cp was removed from the patient. There was no harm to the patient other than the repaired nick.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00018 |
| MDR Report Key | 5765747 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-06 |
| Date of Event | 2016-06-06 |
| Date Facility Aware | 2016-06-06 |
| Date Mfgr Received | 2016-06-06 |
| Device Manufacturer Date | 2016-04-18 |
| Date Added to Maude | 2016-07-01 |
| 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 | ABIOMED, INC. 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 |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-07-01 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1231124 |
| Device Expiration Date | 2018-03-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 49 DA |
| 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 | 2016-07-01 |