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

Model Number	IMPELLA CP
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.The console logs were returned and the analysis of the logs revealed that the pump did not appear to be well positioned throughout the case.The pump was never started, and was plugged in for roughly one hour.The submitted photo of the device along with the clinical account of the event did confirm that the cannula did kink.Although it is highly unlikely for the pigtail of the impella cp to enter the inflow cage, it is possible.Further analysis cannot be completed, however, as no product was returned from for evaluation, and therefore the root cause of the pigtail kinking could not be determined, nor can the failure mode be confirmed without either the product or imaging.A manufacturing review found no other complaints for this failure mode made against this lot of impella pumps.The root cause of the kinking was unable to be determined as the pump was not returned for investigation.Failures of this type will be monitored and trended.Internal reference: (b)(4).
Event or Problem Description
The complainant reported that following stent placement in a 7(b)(6) female patient an impella cp was placed in the left femoral artery without the aid of fluoro imaging.The pump was placed deep into the left ventricle when the cannula kinked and the pigtail of the impella cp appeared to be entrapped in the pump's inflow cage.The physician was unable to free the pigtail.The patient was taken to ct surgery where the device was removed from the left ventricle via the aid of a snare.Another impella cp was obtained and successfully placed in the patient.The patient was supported for 3.25 hours when the patient's family decided to withdraw care, and patient expired.

• Brand Name: IMPELLA CP
• Common Device Name: 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: 7415628
• Report Number: 1220648-2018-00026
• Device Sequence Number: 19175776
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P1400003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1282414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR