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 2016-08-26 for LMPELLA CP PUMP SET LMPELLA CP PUMP SET, US 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[53276649]
The oscor 14french introducer that is part of the impella cp kit was returned for evaluation. A visual and microscopic evaluation was performed that revealed an abnormal and jagged slit on the introducer. The valve surface exhibited marks consistent with an off-axis insertion of the introducer by the user. Leak testing of the valve was performed that revealed bubbles originating from the valve, and confirming that valve was the source of the leak during patient use. With the evidence available, the analysis concluded that the valve was the source of the leak that caused the excessive patient bleeding during the case. This is suggested by the condition of the valve observed under magnification, and the leak testing that was performed. The location of the damage observed on the valve surface suggested that off-axis dilator insertion by the user was the cause of the valve damage. In conclusion, the root cause of the patient bleeding was determined to be valve damage caused by off-axis dilator insertion. A corrective action has been initiated for additional vendor investigation of this event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[53276650]
The complainant reported that on (b)(6) 2016, a (b)(6) year old female patient was admitted to the hospital suffering from chest pain and presenting with a non st-segment elevation myocardial infarction (nstem) and she had an ejection fraction of 30%. A diagnostic catheterization was performed upon the patient's admission which revealed a 95% ostial left anterior descending lesion and proximal circumflex disease. The patient was turned down for a coronary artery bypass graft (cabg), but was brought back to the cath lab the following day for a protected percutaneous coronary intervention (pci. ) the patient act level was reported at 247 and the anticoagulant used was bival. The impella cp was placed without issue. A rotational atherectomy was performed on the lad lesion, and 2 stents were placed. The patient was reported to have been very unstable throughout the case. During the case, the impella flows fluctuated between 2 liters-per-minute and 2. 9 liters-per-minute. At various times during the procedure, the patient required pressor support and volume. I was also reported that the patient's blood pressure was "all over the place", although the patient was reported to have responded well to the pressors. Throughout the case, the patient was very anxious, and was yelling that she needed the bathroom. The physician was unsure if she was having vagal episodes or if the urge was a response to the oscor sheath. At the close of case, it was noted that patient had an extremely large amount of bleeding from the left femoral impella site. It was unclear if the bleeding (approximately 500cc's) was through the valve of the sheath or around the sheath or from both places. There was no hematoma and no internal bleeding noted. The patient hematocrit (hct) reading went from 43 to 27. The impella cp was removed and the patient was then administered 2 units of replacement red blood cells (rbc). Following the removal of the impella and the administration of the rbc's that patient was in stable condition and was off pressor support. No surgical repair was necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00023 |
| MDR Report Key | 5908683 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-26 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-08-01 |
| Date Facility Aware | 2016-08-01 |
| Report Date | 2016-08-01 |
| Date Reported to Mfgr | 2016-08-01 |
| Date Mfgr Received | 2016-08-01 |
| Device Manufacturer Date | 2016-05-26 |
| Date Added to Maude | 2016-08-26 |
| 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 13059GM |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 13059 GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LMPELLA CP PUMP SET |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2016-08-26 |
| Returned To Mfg | 2016-08-05 |
| Model Number | LMPELLA CP PUMP SET, US |
| Catalog Number | 0048-0003 |
| Lot Number | 1235874 |
| Device Expiration Date | 2018-03-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 65 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED EUROPE, GMBH (GERMANY) |
| Manufacturer Address | NEUEHOFER WEG 3 AACHEN, GERMANY 13059GM GM 13059 GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-26 |