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

Model Number IMPELLA CP

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

Patient Problems Perforation (2001); Blood Loss (2597)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

The device has been returned to the manufacturer; however the evaluation has not yet been completed.Upon the completion of the evaluation of the impella cp a supplemental mdr will be submitted.(b)(4).

Event Description

The complainant reported that the clinicians were attempting to place an impella cp in a (b)(6) year old female patient with a very small aortic arch.The clinicians successfully placed the impella cp, but upon the attempted removal of the 0.018 guide-wire the cannula kinked.The physicians then tried to reposition the device but was unsuccessful.The pump was removed from the patient, and reinsertion was attempted but the same issue occurred.Soon after a tamponade was identified which required emergency surgery.When the patient's chest was opened, a left ventricle perforation was found with massive bleeding which required recirculation of blood via cardiopulmonary bypass.The perforation was successfully repaired and hemostasis was achieved, and a coronary artery bypass graft was successfully placed.Following this event, the patient was reported as doing well.The physician reported that he believes that patient size and the patient's small aortic arch contributed to the event.

Manufacturer Narrative

The impella cp and the guide-wire were returned for evaluation.An image returned from the case confirms that a kink formed in the cannula close to the pump housing.A visual evaluation was performed on the returned pump and guide-wire.During that evaluation a kink was found on the guide-wire, and was located approximately 25cm from the guide-wire tip.In addition, evidence of bending and kinking was found on the pigtail.The bent cannula, pigtail, and guide-wire all point to the pump and guide-wire having been inserted too deeply into the patient's left ventricle.Given the fact that a tamponade formed in that same timeframe, it is most likely that either the impella or the guide-wire caused the tamponade; however, without additional evidence indicating which device injured the patient's heart or additional clinical details, the root cause of this event is unable to be definitively determined.A device history review was performed which revealed that there have been no issues or rework relevant to this failure mode documented in the impella cp's device history record.In addition a complaint review was performed, which found that there had been no complaints filed for other pumps from this same lot.Internal reference: spr (b)(4).Please note that this supplemental mdr 1220648-2018-00021-01 is the correct supplemental mdr reporting the evaluation results from this event.This report was originally submitted on 05/01/2018 under the incorrect supplemental mdr number of 1220648-2018-00011-01.

• Brand Name: IMPELLA CP
• Type of Device: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP,
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074, gm, ; GM
• MDR Report Key: 7349476
• MDR Text Key: 102833292
• Report Number: 1220648-2018-00021
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• PMA/PMN Number: P140003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0002
• Device Lot Number: 1311597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR