MAUDE Adverse Event Report: ABIOMED, INC IMPELLA CP; TEMPORARY CARDIAC SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hemolysis (1886); Hematuria (2558)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

The investigation of product, returned by the hospital, included running the pump through internal hemolysis testing in porcine blood twice over four days.Serial plasma free hemoglobin labs were drawn during these three hour tests.The lab results all were below the value which is used to determine hemolysis on the first day of testing.When the hemolysis testing was repeated days later, the results were positive for hemolysis.In addition to the results being of a value that confirmed hemolysis, a defect was seen at the outflow cage that could have contributed to or caused the hemolysis.The defect could protrude and cause obstructed flow.The delaminated area from the sleeve bearing was raised into the outflow cage window.Of note, no plasma free hemoglobin labs were drawn at the hospital.Hemolysis was only documented via a standard cbc and urinalysis, as well as an observation of the urine changing in color and output.In addition to the porcine blood testing, the data logs were analyzed for signs of hemolysis.The logs show the device provided good flow throughout the support.The logs did show suction alarms, however each of these alarms rectified quickly, and can be accounted to the patient's pressure lowering in response to inotropic support.The use of the impella was the most likely cause of the hemolysis.However, the physician stated to the representative that the patient condition could contribute to the hemolysis.As stated in the event description, the patient had multiple contributing cardiac and renal conditions.No corrective action is recommended.The outflow cage defect that prompted the patient to experience hemolysis, with the delamination failure, is of low risk and rare.(b)(4).

Event Description

Complainant reported that on (b)(6) 2016 the hospital staff was treating a (b)(6) admitted with cardiomyopathy, hypertension, and acute renal failure who now presented with elevated labs, edema, and shortness of breath.Patient was treated with lasix and an intraaortic balloon pump.As there was a need for escalated care due to symptoms worsening, the iabp was removed and an impella cp was placed at the same groin access site.Support was seen be successful with good flows and the patient having an easier time breathing.On the next day of support, after a restless night, there was an observed change in the urine output color.A urinalysis was performed and labs pointed to hemolysis.To troubleshoot this issue the catheter position was checked under echo and repositioned.Later in the evening of (b)(6), the staff did remark that the patient was being ruled out for an ileus due to abdominal pain and distension.The patient's condition was monitored and care was again escalated with an increase in inotropes on the following day, (b)(6).Also, the physician decided to give the patient three units of blood replacement products for the hemolysis.The physician did note that the patient's condition could contribute to the hemolysis, along with the use of impella support.The decision was made to wean the patient off of impella support and explant the device.Due to the patient being made a dnr and not being a candidate for a vad device, there is only care and comfort being provided.The patient is being monitored and supported with multiple cardiac medications, including dopamine, levophed, dobutamine, and milrinone.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED, INC; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: william bolt ; abiomed inc.; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 6114602
• MDR Text Key: 60423764
• Report Number: 1220648-2016-00024
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1233151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/04/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2016
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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: 63 YR