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 2016-04-29 for IMPELLA CP 0048-0003 manufactured by Abiomed Europe, Gmbh (germany).
[44120240]
Following this event the abiomed representative conducted retraining of the staff on the insertion of the device and the requirements in placing the device in a patient. The impella cp and introducers were not returned for evaluation. Continued efforts are being made to obtain the devices at issue. Upon the return and completed investigation the manufacturer will provide results and conclusions in a supplemental medwatrch report. It is important to note that the abiomed instructions for use of this device advices the user that the only alternative introducer sheath for use with this device is the (b)(4) check-flo performer introducer (non peel-away) 14fr 30cm. Additionally it is not recommended to cross the aorta valve with an impella cp without a guidewire. Device not yet returned.
Patient Sequence No: 1, Text Type: N, H10
[44120241]
The complainant reported that a (b)(6) male patient was admitted to the facility as a stemi. The physician performed a repair of the patient's lad. The patient was reported to have decompensated during the night and the following day the patient was taken to the cath lab for the possible placement of an iabp and a further pci. Due to low ejection fraction it was decided to place an impella cp. The facility did not have any 14fr 30cm (b)(4) sheaths in inventory, so placement was attempted with an unknown manufacturer's 14fr 13cm sheath. Placement with this sheath was unsuccessful. Despite recommendations from the abiomed representative that placement should be performed with the 14fr (b)(4) sheath that is included in the impella cp kit, the staff selected an (b)(4) 14fr 38cm sheath, which has no history with impella. When the wire was positioned within the left ventricle the patient had multiple runs of ventricular fibrillation and required repeated defibrillations. The physician then attempted to wirelessly to insert impella cp, but was unable to cross the valve despite multiple attempts. A decision made to remove the pump from the patient, but during removal the pump became caught on the (b)(4) sheath and the inlet cage of the pump fractured and detached from the device. The physician was able to successfully remove the device with the aid of 2 snares. Another impella cp was successfully and without issue placed in the patient. The patient was successfully support and the complainant reported that there was no harm to the patient as a result of the reported issue.
Patient Sequence No: 1, Text Type: D, B5
[51357169]
The automatic impella controller data logs and the impella cp were returned for evaluation. The analysis of the data logs revealed that the pump had run briefly with "impella position wrong" alarms occurring prior to the device being explanted by the physician. During the inspection of the returned impella cp pump it was found that the distal portion of the cannula, including the inflow cage, were not returned from the customer. The portion of the cannula that was returned exhibited a fracture in the nitinol coating, and the polyurethane coating was found to have deformed inwards. This condition was reproduced during bench testing while attempting to pull a prolapsed cannula through an introducer. The cannula separated from the inflow cage (with a portion of the cannula remaining on the inflow cage) and remained connected only by the nitinol coil. Two pumps were tested, both failed in the same way. As shown with bench testing a potential root cause of the cannula separation was a prolapse of the cannula, with the cannula doubling over on itself, and the subsequent attempted removal through the introducer. This resulted in generating abnormally high forces on the cannula and its connection to the pump. This prolapse may have been caused by attempting to cross the aortic valve without a wire, which is not a recommended practice per the instructions for use of the impella cp. The instructions for use advises the user of the following: "advance the catheter through the hemostatic valve into the femoral artery and along the placement guidewire and across the aortic valve using a fixed-wire technique. Follow the catheter under fluoroscopy as it is advanced across the aortic valve, positioning the inlet area of the catheter 3. 5 cm below the aortic valve annulus and in the middle of the ventricular chamber, free from the mitral valve chordae. Be careful not to coil the guidewire in the left ventricle. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220648-2016-00010 |
| MDR Report Key | 5620883 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-04-29 |
| Date of Report | 2016-03-30 |
| Date of Event | 2016-03-30 |
| Date Facility Aware | 2016-03-30 |
| Date Mfgr Received | 2016-07-13 |
| Device Manufacturer Date | 2016-03-08 |
| Date Added to Maude | 2016-04-29 |
| 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 | IMPELLA CP |
| Product Code | PBL |
| Date Received | 2016-04-29 |
| Returned To Mfg | 2016-05-05 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0003 |
| Lot Number | 1226190 |
| Device Expiration Date | 2017-12-31 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 22 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 13059, GM GM 13059, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-29 |