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 2016-05-27 for IMPELLA CP IMPELLA CP PUMP SET, US 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[46129599]
The impella cp, sheath, guidewire and console data logs were returned to the manufacturer for evaluation and analysis. A device history review was performed. There were no issues found for any pump in this pump set lot, nor were any records found of any failed inspection criteria relevant to this failure mode. In addition, there have not been any other relevant issues reported to have occurred for any other 14french introducers from this lot. The review of the console data logs for this event did not provide any detailed information, as the logs showed that the pump was inserted for a short period of time. The pump was then removed and never turned on. The pump, 14french introducer and guidewire were returned for investigation. The pump was found to be in good condition with no obvious defects. It was examined to ensure it met outer diameter specification, and was found to be within specification. The introducer was also inspected. The tip of the sheath was found to be split and part of the shaft was pulled back on itself into the sheath. Marks were identified on the tip where it split. Additionally it appeared to have bent inwards when it split. The guidewire was inspected and found to have two severe kinks. During the evaluation an attempt was made to reproduce the reported issue using the pump and guidewire from the case with a new 14fr introducer sheath. The guidewire was placed through the pump and the pump was inserted through the sheath. The kink on the guidewire was placed between the outflow cage and the tip of the introducer. Attempts were made to pull the pump through the sheath tip while the test setup was inside simulated vasculature. The failure mode was not able to be reproduced during this test. In conclusion, because the failure mode was unable to be reproduced, a definitive root cause for this event was unable to be determined. From the case notes it is apparent that the femoral artery repair was necessary because the sheath no longer provided access after the pump was removed. Most likely the sheath tip split because of interaction between the sheath tip, outflow cage, and guidewire. No corrective action was initiated, as a definitive root cause was unable to be established. This failure mode will continue to be monitored. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[46129600]
The complainant reported that on (b)(6) 2016 an aortic and mitral valve replacement procedure was performed on a (b)(6) male patient; following this procedure the patient required multiple inotropes, pressors and required an intra-aortic balloon pump to be placed. The patient continued to struggle hemodynamically after surgery; consequently, on (b)(6) 2016 patient support was escalated to the placement of an impella cp. The 14fr introducer was placed in the patient's left groin without difficulty. During the impella placement procedure a. 035 guidewire and a pigtail catheter were placed across the aortic bioprosthetic valve. The. 035 guidewire was exchanged for a. 018 guidewire and the impella cp was back-loaded onto the. 018 guidewire. The physician reported that he was unable to advance the pump across the aortic valve. While pulling the impella catheter and the. 018 guidewire back thru the 14fr introducer, part of the shaft of the sheath pulled back through the hemostatic valve of the sheath, and the wire become entangled in the sheath shaft section that had prolapsed out of the hemostatic valve. Upon further inspection it appeared that the sheath had somehow split open from the distal tip and had pulled back up into the hemostatic valve as the doctor was pulling the impella catheter and wire out of the sheath. The physician then attempted to re-wire the sheath in order to exchange it out for a 14fr cook brand, but was unable to advance the wire into the sheath and back into the femoral artery. At this point, it was obvious that the distal tip of the 14fr introducer was no longer in the artery and the lumen was no longer patent, and the patient was found to have incurred a vascular injury necessitating surgical repair of the femoral artery. After the successful repair of the left femoral artery, the patient was still hemodynamically unstable and required continued mechanical circulatory support. A new impella cp was placed percutaneously in to the left femoral artery above previous site. The physician reported that the patient was in stable condition following the arterial repair and the placement of the second impella cp. There were no further issues reported following patient support with the replacement impella cp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00014 |
| MDR Report Key | 5686283 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-27 |
| Date of Report | 2016-04-29 |
| Date of Event | 2016-04-29 |
| Date Facility Aware | 2016-04-29 |
| Date Mfgr Received | 2016-04-29 |
| Device Manufacturer Date | 2016-04-29 |
| Date Added to Maude | 2016-05-27 |
| 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 | 2016-05-27 |
| Returned To Mfg | 2016-05-03 |
| Model Number | IMPELLA CP PUMP SET, US |
| Catalog Number | 0048-0003 |
| Lot Number | 1197967 |
| Device Expiration Date | 2017-05-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 9 MO |
| 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 13059, GM GM 13059, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-27 |