MAUDE Adverse Event Report: ABIOMED EUROPE, GMBH (GERMANY) IMPELLA CP; TEMPORARY CARDIAC SUPPORT BLOOD PUMP

Model Number IMPELLA CP PUMP SET, US

Device Problems Fracture (1260); Kinked (1339)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• 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: 5686283
• MDR Text Key: 46129599
• Report Number: 1220648-2016-00014
• Device Sequence Number: 1
• Product Code: PBL
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1400003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: IMPELLA CP PUMP SET, US
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1197967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/29/2016
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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: 60 YR