MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-05-05 for IMPELLA CP 0048-0004 manufactured by Abiomed Europe, Gmbh (germany).
[44553018]
The device was returned to the manufacturer for evaluation. The impella cp was evaluated and the aic logs were analyzed. A review of the data logs showed that the pump was inserted at approximately 14:16 on (b)(6) 2016. The pump was then started one minute later. At 14:45 there was an "impella position unknown" alarm. This may have been the result of the pump having been pulled out of the ventricle at this point. The evaluation of the pump revealed that there was a kink at the 56cm mark, and the wound closure sheath had been damaged. The tip of the repositioning sheath did not appear to be damaged. The catheter was cut by the evaluating engineers so that the repositioning sheath could be examined. The wound closure sheath was found to be cracked and torn in the area where it transitions to the sheath. A fluoroscopy image was also submitted for analysis. The image from the case showed the position of the repositioning sheath and was interpreted as showing the repositioning sheath positioned alongside of the artery. It appears that this was responsible for pulling the catheter back out of the heart and into the patient's abdomen. This could have contributed to the kink and the damage sheath that was observed during the failure analysis. Failures of the wound closure sheath in the past have been attributed to the manufacturing process of flash removal which could result in small cracks and tears in the wound closure sheath and can contribute to failure of the device when under stress. In conclusion, the root cause of the damage to the repositioning sheath was that the sheath and catheter were pushed up alongside the artery during placement. This event may have been avoided with the careful use of fluoro guidance. The impella cp instructions for use warns the user of the following: never advance the guidewire or sheath when resistance is met. Determine the cause of resistance using fluoroscopy and take remedial action. Fluoroscopy is required to guide placement of the impella? Catheter. The small placement guidewire must be reliably observed at all times. The manufacturing process of flash removal was corrected with a product change. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44553019]
The complainant reported that a (b)(6) year old "heavy set" male patient in cardiogenic shock due to an occluded left main (lm) was transferred to this facility for the placement of an impella cp. The physician reported that the patient was in cardiogenic shock due to thrombus in the left main. The patient's lvedp was elevated at 40 and he was on levophed of 15ug/minute. The physician completed revascularization by removing a clot in the lm and no stents were needed. The 14 french peel away sheath was inserted effortlessly, but the physician was observed having difficulty with the repositioning sheath, and appeared to be "fussing over it. " the physician performed the placement of the repositioning sheath without the aid of fluoro coverage. Within 3 minutes of placement the impella catheter migrated out of the ventricle. Adjustments were made and catheter fluoro images were then taken of the groin. The images indicated that the catheter was in the patient's abdomen. Ten to fifteen minutes later, the patient became hemodynamically unstable and started bleeding. Anesthesia, vascular surgery and another interventionalist were called to assist. They did see under fluoro what appeared to be two puncture sites that were sites of blood loss. One was seen to be above the access site and was bleeding profusely, while the one below was not bleeding out to that extent. The fluoro images indicated that the cannula tracked along the side of the artery and had never entered the artery. A balloon catheter was inserted via the left femoral artery and occluded the right artery proximally. Unfortunately, the patient expired before the vascular surgeon could intervene. The staff reported that the cause of the patient outcome cause was reported as "stemi"; furthermore, the team stated that the patient would have expired without the impella device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220648-2016-00009 |
| MDR Report Key | 5635857 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-05 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-04-05 |
| Date Facility Aware | 2016-04-05 |
| Report Date | 2016-04-05 |
| Date Reported to Mfgr | 2016-04-05 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2015-12-03 |
| Date Added to Maude | 2016-05-05 |
| 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 | 2016-05-05 |
| Returned To Mfg | 2016-04-11 |
| Model Number | IMPELLA CP |
| Catalog Number | 0048-0004 |
| Lot Number | 1215341 |
| Device Expiration Date | 2017-03-03 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 4 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 | 2016-05-05 |