MAUDE Adverse Event Report: ABIOMED, INC IMPELLA CP; TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problems Kinked (1339); Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 11/05/2017

Event Type  malfunction  

Manufacturer Narrative

The impella cp was discarded following removal from the patient; consequently an evaluation of the pump at issue could not be performed.The 14french introducer is being held by the hospital's adminstration department.A console data log analysis was not included in this report because data logs are not relevant to this failure mode.The root cause of this event could not be determined.No corrective action has been recommended because the evaluation has not yet been performed.Internal reference: (b)(4).

Event Description

Complainant reported that during the week of (b)(6) 2017 a (b)(6) female patient had undergone an aortic valve replacement (avr).The patient was reported to be obese with a large panis.Following the avr the patient decompensated, and as a result an emergent 3 vessel coronary artery bypass graft (cabg) was performed.After the cabg was performed the patient, in a semi-stable condition, was brought to the icu with an intra-aortic balloon pump (iabp) that had been supporting the patient.The iabp was weaned from the patient and removed.On (b)(6) 2017 the patient decompensated.The physician then decided to place an impella cp for support.The patient coded as she was being prepped.Cpr was started and continued throughout the attempted placement of the impella cp.The 14fr introducer sheath was placed in the patient's right femoral artery that had also been accessed with the iabp.Visualization was reported to be poor during the placement of the pigtail, and it would not advance to the left ventricle (lv).A fluoroscopy was performed which revealed that the wire was looped within the artery.The physician then attempted to gain access of the left femoral artery, but was unable to gain access due to active cpr and low pulsility.The venous was accessed only.Without the return of spontaneous circulation (rosc), the procedure was aborted and the patient expired.Upon removal of the 14fr introducer sheath from the right femoral artery it was found to be kinked and that the peel-away portion of the sheath had cracked.The physician reported that the patient outcome was not as a result of any issue with the impella cp.The physician categorized this case as a "salvage situation", and that access attempts were ceased.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART 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: ralph barisano ; 22 cherry hill drive; danvers 01923 ; 9788828068
• MDR Report Key: 7060828
• MDR Text Key: 93601382
• Report Number: 1220648-2017-00111
• 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: 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: 11/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2017
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1291379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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 Age: 75 YR