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 2016-06-15 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[47489209]
The impella cp was not returned for evaluation as the pump was discarded by the staff following explant. The console logs were returned for analysis, the analysis of the logs suggested that the impella cp was out of position repeatedly which could have contributed to the patient's hemolysis; however because the impella was not returned the root cause of the hemolysis was unable to be definitively confirmed. Because the root cause of this event could not be determined, no corrective action is recommended. (b)(4). Device discarded subsequent to use.
Patient Sequence No: 1, Text Type: N, H10
[47489210]
The complainant reported that a (b)(6) year old male patient had been admitted to the hospital on (b)(6) 2016 as a result of chest pains and shortness of breath. This patient also had an increase in his troponin levels. This patient had a history of multiple myocardial infarctions and stent placements. An implantable cardioverter defibrillator/pacemaker (icd) had been previously placed. The patient was reported to have had runs of ventricular tachycardia (vtach) for a week with the icd shocking him into a normal heart rhythm. Upon admittance into this facility the patient an ejection fraction of 15, and was intubated, but became worse necessitating pressors /inotropic support. The patient's lactic acid had also increased. Following the placement of the impella cp an angiography was performed which revealed a mid-right coronary artery (rca). A stent was successfully placed at the rca. After stent placement the pump was found to need repositioning; the physician repositioned under echo guidance, but each time he pulled back further the pump would come back into the aorta. The patient was in stable condition, and it was planned to allow the patient to rest for a couple of days. The following day the impella again needed repositioning. The device was repositioned. The patient was reported to have been in stable condition during the previous night, but on this day the patient's urine was found to be "bloody. " repositioning was again performed. That night the patient had a run of vtach and had coded. Cpr was performed on the patient. After the code the impella required repositioning and the patient was found to have developed a large hematoma at the groin site, occurring as a result of patient movement during the code; pressure was held on the groin and the hematoma and oozing resolved quickly without incident and harm. It was then reported that after the repositioning of the pump earlier that same day the patient's labs had continued to hemolyze. The patient remained stable throughout the remainder of the night, without any more incidents of vtach, although the patient's troponins continued to rise and the patient remained "very diaphoretic. " the patient was then transferred to another facility on (b)(6) 2016. Upon arrival at this hospital a transesophageal echocardiography (tee) was performed which revealed that the impella cp was positioned in the mid-ventricular. The patient's urine had lightened a bit and the first sets of labs performed at the new facility were not hemolyzed. A second set of labs using "special tubes" was performed this set of labs did show hemolysis. This prompted staff's decision to explant the device after more than 42 hours of impella cp support. An ecmo was placed. The patient was reported to be stable on the ecmo and on dialysis treatment. The patient did recover and was discharged home and was no longer on dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00012 |
| MDR Report Key | 5727576 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-15 |
| Date of Report | 2016-05-16 |
| Date of Event | 2016-05-16 |
| Date Facility Aware | 2016-05-16 |
| Report Date | 2016-05-16 |
| Date Reported to Mfgr | 2016-05-16 |
| Date Mfgr Received | 2016-05-16 |
| Device Manufacturer Date | 2015-10-16 |
| Date Added to Maude | 2016-06-15 |
| 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 | 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 |
| Product Code | PBL |
| Date Received | 2016-06-15 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1209437 |
| Device Expiration Date | 2017-07-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 7 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 | 2016-06-15 |