MAUDE Adverse Event Report: ABIOMED EUROPE GMBH IMPELLA; IMPELLA CP PUMP SET, US

Model Number IMPELLA CP

Device Problems Kinked (1339); Device Issue (2379); Patient-Device Incompatibility (2682); Human Factors Issue (2948)

Patient Problem Blood Loss (2597)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

The first impella cp, which kinked with movement, was returned for evaluation.The first device was free of any damage that would have contributed to the access site bleeding.The cannula was visibly kinked near the outflow cage.The second impella cp was not returned for evaluation.It is unclear at this time if the bleeding was as a result of any issue with the introducer or impella cp pump.The necessary product was not available for review so the root cause of the access site bleeding was unable to be determined.The data logs were analyzed from the first cp pump.The data logs for the second device were not returned.Upon review of the lot of cp pumps, there were no other complaints for this pump, nor any reworks that apply to the failure mode.There is no corrective action recommended because the root cause was unable to be determined.The failure will continue to be tracked and trended.Should the manufacturer obtain any other sources of information, a supplemental medwatch will be filed with investigation results.(b)(4).

Event Description

An obese (b)(6) male was taken to the cardiac cath lab , and found to have a dissection of the right coronary artery, as well as multivessel disease.The patient was unstable and in need of 3 stents to his rca and an intra aortic balloon pump (iabp) was placed on (b)(6) 2017.The iabp was not sufficient support, and so care was escalated and an impella cp was placed.There were unconfirmed reports that the oscor sheath was cracked/removed while in the vessel, prior to placement of the repositioning sheath and transfer to the icu.The ifu states: "remove the peel-away introducer completely from the artery over the catheter shaft to prevent trauma and significant bleeding and apply manual pressure above the puncture site." in addition the ifu states: "when securing the repositioning sheath, vascular closure may be difficult in obese patients with extensive adipose tissue." the pump was seen to jump forward and out of desired position.During this movement, the pump kinked.The cp pump was explanted and a second cp was placed in the opposing leg.The patient was transferred to the icu while on cp support.The patient was noted to be unstable and receiving blood replacement products.In total the patient received 5 units of blood due to ooze and profuse bleeding at the groin access sites.The patient was then transferred to a second, tertiary, medical center for monitoring and care.At the second medical center the team applied a femostop to the groin site and consulted vascular surgery.The femostop pressure was released during cp repositioning in the left ventricle.With the pressure released from the femostop there was blood lost and 3 more units of blood were given.On the following day the bleeding had reduced and the patient was noted to be stable.The support continued for six days allowing cardiac iv meds to be discontinued and the patient to recover from the cardiogenic shock.The patient's ejection fraction rose from 10% to 30%.The team was also able to complete the coronary artery revascularization.The circumflex and ramus coronary arteries were stented with 4 stents in total.On the (b)(6) the impella cp was weaned and explanted.This was the 10th day of support.

• Brand Name: IMPELLA
• Type of Device: IMPELLA CP PUMP SET, US
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074 ; GM 52074
• Manufacturer (Section G): ABIOMED INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 6424216
• MDR Text Key: 70553388
• Report Number: 1220648-2017-00018
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140003
• 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: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1269856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2017
• 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
• Treatment: FEMOSTOP; INTRA AORTIC BALLOON PUMP
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR