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

Model Number	IMPELLA CP
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914)
Date of Event	12/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the patient's hematoma could not be determined, as the product and data logs were not returned.A manufacturing review found no other complaints for this failure mode made against the lot of impella pumps.Failures of this type will be monitored and trended.(b)(4).
Event or Problem Description
A (b)(6) male was admitted with influenza.Upon admission to the hospital he had a cardiac catheterization which revealed multivessel coronary artery disease, had an impella cp placed for support, and an angioplasty was performed.During the overnight hours in the icu, the patient developed a hematoma at the groin site and he became hypotensive.Volume, in the form of iv fluids, and blood was given to the patient and the team explanted the impella cp with the help of the surgical team.The patient had a new impella 5.0 placed axillary and his hemodynamic support continued.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7282801
• Report Number: 1220648-2018-00007
• Device Sequence Number: 1210418
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1307590
• 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: 01/24/2018
• Initial Report FDA Received Date: 02/20/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 42 YR