MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-17 for IMPELLA CP PUMP SET 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[53446087]
The impella cp has not yet been returned for evaluation as it is currently being held in the complainant's risk management department; consequently, no device analysis could be performed. Upon the release and return of the device an evaluation will be performed and the results and conclusions will be reported in a supplemental medwatch report. (b)(4). Held in user's risk management department.
Patient Sequence No: 1, Text Type: N, H10
[53446088]
The complainant reported that on (b)(6) 2016 a (b)(6) male patient presented at the hospital with a totally occluded right coronary artery (rca) and left anterior descending coronary artery (lad). The patient's left main (lm) was also found to be diseased. An impella cp was placed to allow hemodynamic support to the patient during stenting. Following successful stenting of the lm and lad, the rca was opened, but only one stent was able to be applied to the rc. The physician was unable to fully complete the repair of the rca, as radiation usage was reported to have become too high. The patient was then transferred to the intensive care unit (icu) and was reported to be doing well with the impella cp support successfully continued. The patient was administered heparin and integrin, blood seepage was then observed around the repositioning sheath and the right angioseal site. A femstop was then applied and the seepage was resolved. After over 22 hours of successful support the patient was reported to have been both looking and feeling better. It was then decided to remove the impella cp. During explant of the device the pump cannula separated into 2 pieces. The separated portion was able to be retrieved by hand at the femoral insertion site after the application of slight pressure to the surrounding tissue. Following removal of the impella pump hemostasis was obtained. There were no adverse effects to the patient and the patient was reported to be in stable condition following the removal of the impella cp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00021 |
| MDR Report Key | 5883961 |
| Date Received | 2016-08-17 |
| Date of Report | 2016-07-19 |
| Date of Event | 2016-07-19 |
| Date Facility Aware | 2016-07-19 |
| Report Date | 2016-07-19 |
| Date Reported to Mfgr | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Device Manufacturer Date | 2016-07-11 |
| Date Added to Maude | 2016-08-17 |
| 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 | 0 |
| Brand Name | IMPELLA CP PUMP SET |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-08-17 |
| Model Number | 0048-0003 |
| Catalog Number | 0048-0003 |
| Lot Number | 1241332 |
| Device Expiration Date | 2018-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 8 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 | 2016-08-17 |