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 CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[48668027]
A definitive root cause of the perforation could not be determined. The pump was discarded subsequent to the event and was consequently unavailable for analysis. The exact cause could not be determined from the available data. The analysis of the data revealed that the patient's pressure decreased after the pump insertion and pulsatility decreased substantially. This behavior suggested that the left ventricle was perforated. As stated in the event description according to information from the clinician the patient's left ventricle wall was calcified and thinner than the average person's ventricle, which resulted in the perforation. (b)(4). Device discarded by user.
Patient Sequence No: 1, Text Type: N, H10
[48668028]
Complainant reported that on (b)(6) 2016 the hospital staff was treating a (b)(6) year old male patient with an ejection fraction of 30%, multi vessel disease and a coronary chronic total occlusion (cto). Of the left circumflex artery (lcx). The patient was scheduled to undergo a high-risk percutaneous coronary intervention (hrpci. ) the impella cp was placed for patient support on (b)(6) 2016, but approximately 5 minutes after insertion the patient's pressures dropped. Following the drop in pressures, the physician determined that the patient's left ventricle was perforated. The patient was taken to the operating room where the impella cp was removed and the ventricle was repaired and 2 perclose sutures were applied. The physician indicated that the patient's left ventricle wall was calcified and thinner than the average person's ventricle, which resulted in the perforation. The patient was reported to be in stable condition following the surgical repair of the left ventricle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00017 |
| MDR Report Key | 5765740 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-01 |
| Date of Report | 2016-06-03 |
| Date of Event | 2016-06-03 |
| Date Facility Aware | 2016-06-03 |
| Report Date | 2016-06-03 |
| Date Reported to Mfgr | 2016-06-03 |
| Date Mfgr Received | 2016-06-03 |
| Device Manufacturer Date | 2016-05-16 |
| 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 CP |
| 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 | 1234487 |
| Device Expiration Date | 2018-04-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 18 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 |