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

Model Number	IMPELLA CP
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Perforation (2001); Blood Loss (2597)
Date of Event	12/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product and data logs have not yet been returned for analysis.Requests have been made for more clinical details and imaging have not been met to date.Should more information be shared, or product returned, a detailed analysis and subsequent medwatch will be filed.(b)(4).
Event or Problem Description
A (b)(6) female was admitted with cardiogenic shock and acute mi.Upon admission to the cardiac cath lab she had an angioplasty (pci) of the left anterior descending (lad) coronary artery.After the lad pci was successfully completed the team chose to place an impella cp for hemodynamic support.Shortly after the cp was placed there was a "wrong position" alarm and the physician chose to adjust the position within the left ventricle (lv) under fluoroscopic guidance.While moving the cp deeper into the lv there was a feeling of resistance and so the physician stopped advancing the cp.The position alarm resolved at that time, though now the console alarmed for suction.Again under imaging guidance, this time echo rather than fluoroscopy, the cp was repositioned and at this time the team noted the lv to be depressed and have an effusion.The team urgently began to treat her for the effusion with a code being called and a pericardiocentesis being performed.The pericardiocentesis withdrew blood from the cavity.The team did infuse blood products back to the patient and took her to the or to repair the lv perforation.The perforation was noted to be on the posterior portion of the heart.It was repaired surgically, the cp was explanted, and the patient was reported to be stable on medical therapy.No other hemodynamic support device was placed.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• MDR Report Key: 7205713
• Report Number: 1220648-2017-00131
• Device Sequence Number: 854149
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P1400003
• 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): 12/28/2017

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: 10/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1314907
• 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: 12/28/2017
• Initial Report FDA Received Date: 01/19/2018
• 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: 55 YR