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

Model Number IMPELLA CP

Device Problems Difficult To Position (1467); Device Issue (2379); Patient-Device Incompatibility (2682)

Patient Problem Hemolysis (1886)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

The impella cp pump and data logs were returned for analysis.The data log analysis confirmed the clinical report of the pump position being adjusted in relation to the valve.As the ifu states hemolysis is a "known potential adverse event" and furthermore: "evaluate the position of the impella® catheter if the automated impella® controller displays position alarms or if you observe lower than expected flows or signs of hemolysis.If the catheter does not appear to be correctly positioned, initiate steps to reposition it." the p-level changes, observed within the data logs, also coincide with the clinical report.The p-levels were decreased in an attempt to resolve hemolysis.Later the p-level was increased, while the pump was in proper position, and the hemolysis issues worsened, according to the clinical account, within hours.The p-level was again decreased and hemolysis issues reportedly resolved.The cp pump itself was analyzed, and nothing was identified on the pump that could have caused or contributed to the hemolysis.The pump was run through standard hemolysis testing procedures and passed.The reported failure was not reproduced.The lot of cp pumps was investigated in a manufacturing review.No other pumps have complaints leveled from the field for hemolysis.There is no corrective action as the root cause of the hemolysis could not be determined.The failure will continue to be monitored and trended.Internal reference (b)(4).

Event Description

On (b)(6) 2017 a (b)(6) year old male was taken to the emergency room after experiencing chest pain during a cat scan.He had a cardiac arrest in the er and was taken to the cardiac cath lab for care.The impella cp was placed for support due to the need for support during angioplasty to the left main, left anterior descending, and left circumflex coronary arteries.That evening, he was admitted to the icu for monitoring.Upon admission to the icu the patient's urine output began to change color and an echo was obtained to evaluate position in the left ventricle (lv) of the impella cp in relation to the valve.The standard blood draws were also hemolyzing at the time.The team did not take the advice of the abiomed representative, and re-adjust position of the impella.The following morning, the (b)(6), the position of the impella cp was adjusted from 1.4cm to 3.4cm.According the ifu of the impella cp: "positioning the inlet area of the catheter 3.5 cm below the aortic valve annulus and in the middle of the ventricular chamber, free from the mitral valve chordae." the patient was infused with 3 units of red blood cells after repositioning.The patient's hematocrit and hemoglobin were 8.9 and 24.2.Throughout the days of the (b)(6), the urine output and color were monitored.The color was still indicative of hemolysis.The patient was also placed on dialysis with his creatinine level being 6 mg/dl.Throughout the day of (b)(6) the team made adjustments to the pump's p level in attempted troubleshooting for the signs of hemolysis, although this did little to remedy the urine color change.Only with repositioning of the pump did the urine output improve.On the (b)(6) the urine color was clearing and impella weaning began.On the night of the (b)(6) the impella was explanted and the patient recovered without harm or injury.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• 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 ; 9786461400
• MDR Report Key: 6866544
• MDR Text Key: 86318722
• Report Number: 1220648-2017-00067
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0020
• Device Lot Number: 1285513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR