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

Model Number IMPELLA CP

Device Problems Kinked (1339); Difficult to Remove (1528); Device Issue (2379)

Patient Problems Perforation of Vessels (2135); Blood Loss (2597)

Event Date 04/23/2018

Event Type  Injury  

Manufacturer Narrative

The impella pump was returned for analysis.The data logs were not retrieved.Upon examination of the pump there was damage noted as the catheter was stretched and broken.Biomaterial was observed within the catheter's cannula.The pump housing was noted to be deformed and damaged.The root cause of the femoral artery dissection was most likely the excessive force used to remove the guidewire and pump.The root cause of the necessity for this excessive force is unable to be determined.No corrective action is warranted, the failure mode will be monitored and trended.Internal reference (b)(4).

Event Description

A patient admitted with cardiogenic shock and acute mi had an impella cp placed with difficulty via the right femoral artery during cpr.Due to the pump kinking, when the guidewire was removed, the pump was explanted to resolve the kink.Upon reinsertion the right femoral artery was observed to be dissected.The patient had the dissection tamponade by the placement of a 14fr introducer and the case and cpr continued, until his death from cardiogenic shock and failed cpr and defibrillations.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART 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: 7496264
• MDR Text Key: 107655622
• Report Number: 1220648-2018-00041
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1319167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• 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: 52 YR