MAUDE Adverse Event Report: ABIOMED EUROPE, GMBH (GERMANY) IMPELLA CP

Model Number IMPELLA CP

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Blood Loss (2597)

Event Date 04/05/2016

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: IMPELLA CP
• Type of Device: IMPELLA CP
• Manufacturer (Section D): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen, germany 13059 , GM; GM 13059, GM
• Manufacturer (Section G): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen, germany 13059 , GM; GM 13059, GM
• Manufacturer Contact: william bolt ; abiomed, inc.; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 5635857
• MDR Text Key: 44553018
• Report Number: 1220648-2016-00009
• Device Sequence Number: 1
• Product Code: PBL
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/03/2017
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0004
• Device Lot Number: 1215341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/05/2016
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2016
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR