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

Model Number IMPELLA CP

Device Problems Kinked (1339); Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(4), a user medwatch 3500a was received.This medwatch form did contain new information regarding the patient event, inclusive of the fact that the pump placement took place at the left femoral artery.The hospital did not return for analysis the impella cp, 14 fr introducer, or data logs for analysis.Because the product and data could not be inspected, the root cause of the cannula kink was unable to be determined.A manufacturing review was done, which revealed no other complaints leveled against this lot of pumps.The failure mode was determined to be a low risk index based on very low occurrence and moderate severity.The failure mode will be trended and tracked.Internal reference (b)(4).

Event Description

A (b)(6) year old male presented with cardiac arrest and was taken to the cardiac catheterization lab for care.The patient had a 14fr x13cm sheath placed for insertion of an impella cp pump.This was done independent of any abiomed field representative support.The abiomed representative was later told that the insertion of the impella cp was not successful, as the cp pump had kinked back upon itself after insertion.The kink was noted to have occurred in the left ventricle near the pump motor housing.The team had attempted to straighten the pump, but the flows were low, and the pump placement was aborted and the pump explanted.As the 14fr introducer had been peeled away, the team had to perform a surgical removal of the impella cp, and a surgical groin wound closure.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 6990235
• MDR Text Key: 91932844
• Report Number: 1220648-2017-00095
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• 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: 0048-0003
• Device Lot Number: 1288788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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: 42 YR