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 2016-04-20 for IMPELLA LP2.5 5042 manufactured by Abiomed Europe, Gmbh (germany).
[43154806]
The device was not returned for investigation; consequently a device failure evaluation could not be performed. The aic console logs were returned for analysis. The data logs provided information on the pump's performance and the patient's condition during the case. The long time logs showed that there was good patient pressure throughout the case. The normal patient pressures that were recorded for almost 2 days before the surgery make it unlikely that the ventricle was perforated during pump insertion. Cardiac tamponade symptoms can manifest in as little as 30 minutes after perforation of the ventricle wall. No symptoms were noted leading up to the procedure making it unlikely that the ventricle was perforated before the cabg began. In addition, the logs show good flow and there were no suction alarms before the surgery. If a leak was present during support, low volume would cause suction alarms to be triggered. Good flow suggests the ventricle was intact and completely sealed. It is likely that the ventricle was perforated during the surgery. The physician noted that the patient's cardiac tissue was prone to tears. The pump could have perforated the ventricle at two points during cabg. It is possible that when the pump was cross clamped it could have been moved and pushed through the wall, or it could have occurred when the physician manipulated the heart to look for targets. In conclusion, without the ability to evaluate the device in an effort to obtain additional information a definitive root cause for this event could not be determined. It is most likely that the root cause of the perforation was the friable cardiac tissue in the patient combined with manipulation of the heart during bypass with the impella in place. Device was discarded subsequent to use.
Patient Sequence No: 1, Text Type: N, H10
[43154807]
The complainant reported that on (b)(6) 2016 a (b)(6) patient entered the facility's emergency room complaining of shortness of breath and chest pains. The patient was examined and was found to have elevated troponin levels. The patient was taken to the catheterization lab where a diagnostic catheterization was performed that revealed multi-vessel disease and weak left ventricle (lv) function. An impella lp2. 5 pump was placed in the patient without issue. The patient brought to the operating room on (b)(6) 2016 for 5 coronary artery bypass grafts (cabg. ) the physician performed the procedure using the "cross clamp" technique. When the doctor clamped the aorta and manipulated the heart looking for targets the catheter pigtail was seen be sticking out of the ventricle. The catheter was immediately pulled back and the physician stitched the perforation. With the repair successfully completed the doctor completed the grafts. The clamps were then removed and the impella lp2. 5 was repositioned back across the valve. The physician stated that the patient had "friable tissue. " when stitching the aorta he found that the tissue was thin and could be torn easily. The clinical team believed that the left ventricle perforated when the heart was manipulated during the cabg procedure or possibly during cross clamping. Following the procedure the patient was returned to the intensive care unit in stable condition. The patient had been successfully supported with the impella lp2. 5 for over 67 hours when the impella lp2. 5 was removed from the patient. The patient was reported to be "doing very well. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00006 |
| MDR Report Key | 5591533 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-20 |
| Date of Report | 2016-03-25 |
| Date of Event | 2016-02-12 |
| Date Facility Aware | 2016-03-25 |
| Report Date | 2016-03-25 |
| Date Reported to Mfgr | 2016-03-25 |
| Date Mfgr Received | 2016-03-25 |
| Device Manufacturer Date | 2015-12-28 |
| Date Added to Maude | 2016-04-20 |
| 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 | 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 LP2.5 |
| Generic Name | IMPELLA LP2.5 |
| Product Code | PBL |
| Date Received | 2016-04-20 |
| Model Number | IMPELLA LP2.5 |
| Catalog Number | 5042 |
| Lot Number | 1217967 |
| Device Expiration Date | 2017-10-17 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 47 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 | 2016-04-20 |