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 2016-05-27 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[46133181]
The products involved in this event were discarded by the user subsequent to use. The console logs were returned to the manufacturer for analysis. An analysis of the console logs was performed, but was unable to reveal the cause of this issue. An examination of the reported event details revealed that this patient was on pressors, and that he was also exhibiting decreased arterial flow to the leg. With those issues the placement of an impella cp could have exacerbated the reduced flow to the patient's leg. Without the product being returned no evaluation could be done on the repositioning sheath; therefore a definitive root cause for this event could not be determined. It is unclear if this reported issue was related to the impella cp's repositioning sheath or if the issue was the result of the physician's device placement/management, or the patient's condition. The manufacturer will continue to investigate all reasonable obtainable source information, and will provide them on a supplemental medwatch report if they become available. (b)(4). Device discarded by user facility.
Patient Sequence No: 1, Text Type: N, H10
[46133182]
The complainant reported that on (b)(6) 2016 a (b)(6) female patient was admitted to the hospital with a total heart block. The physician performed the placement of bare metal stents to the circumflex and the left ascending artery (lad) and repaired a chronic total occlusion. During the 3. 5 hour procedure the patient was successfully supported via the right femoral artery with an impella cp. Following the procedure the patient continued to be supported by the impella pump and was administered pressors and inotropes. The patient was supported with the impella cp for a total of 38 hours. The patient was reported to have did have "deplorable" pulses in the right leg, but that the leg was cool when admitted to the icu. On (b)(6) 2016 the physician found that the patient's right impella leg was still cold and the pump was removed. A fasciotomy was reported to have been performed on the patient's right leg. Following the fasciotomy the patient was reported to be in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00013 |
| MDR Report Key | 5686403 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-27 |
| Date of Report | 2016-04-27 |
| Date of Event | 2016-04-24 |
| Date Facility Aware | 2016-04-27 |
| Device Manufacturer Date | 2015-10-14 |
| Date Added to Maude | 2016-05-27 |
| 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 CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-05-27 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1209230 |
| Device Expiration Date | 2017-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 6 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 | 2016-05-27 |