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

Model Number IMPELLA CP

Device Problems Kinked (1339); Device Issue (2379); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2017

Event Type  malfunction  

Manufacturer Narrative

The impella cp pump product and data logs were returned for analysis, however the investigation is on-going at this time.A supplemental medwatch will be completed upon investigation completion.(b)(4).

Event Description

On (b)(6) 2017 a (b)(6) male was admitted with acute myocardial infarction and cardiogenic shock.He was in need of hemodynamic support for a staged cardiac procedure.The plan was to first complete a coronary artery intervention/pci, followed by a valvuloplasty for aortic valve stenosis.The pci was completed and then the patient decompensated during the valvuloplasty, and so the impella cp was placed.Upon insertion of the impella pump, via the right femoral artery, the cp pump was seen to kink and twist back upon itself.The team needed to intervene in the form of a snare to remove and explant the pump.A new impella was then placed.The second impella was a 2.5 rather than another cp.The second pump supported the patient successfully for three days.

Manufacturer Narrative

Since filing the initial medwatch for on (b)(6) 2017, the investigation has been completed.The pump, data logs, and imaging were evaluated and analyzed.The manufacturing review found no other complaints for this failure mode for the lot of impella cp pumps.The pump was analyzed and found to have significant and numerous kinks on the catheter shaft.In addition, there was kinking observed on the.018 guidewire.Imaging further confirmed the failure mode and kinking on the catheter.The root cause of the kink, which necessitated the use of a snare to remove the pump, was unable to be determined.Of note, in the clinical case review, there is mention of the patient having aortic valve stenosis (as).Within the ifu of the impella cp there is a cautionary statement of: "patients with aortic stenosis or other abnormal aortic valve performance may be compromised by the use of the impella catheter." and aortic stenosis is further classified as contraindicated in: "aortic valve stenosis/calcification (equivalent to an orifice of 0.6 cm2 or less)." the fact that the patient had known as could increase the difficulty of crossing the valve with the pump.No corrective action is warranted at this time, however the failure mode will be trended and monitored.(b)(4).

• 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: 7028673
• MDR Text Key: 92775476
• Report Number: 1220648-2017-00101
• 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: K083111
• 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,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1266569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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: 62 YR