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

Model Number	IMPELLA CP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Blood Loss (2597)
Date of Event	08/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On march 13, 2018 a cardiol res and elmer press inc¿ journal article was found.The date of the event was not reported and abiomed was unable to find a corresponding event that had been reported for any customer.Abiomed has used the manuscript submission date of august 19, 2017 as the date of the event.No device was returned for evaluation, and abiomed was unable to obtain any additional information regarding this event.(b)(4).
Event or Problem Description
On (b)(6) 2018 a cardiol res and elmer press inc.¿ journal article was found.The date of the event was not reported and abiomed was unable to find a corresponding event that had been reported for any customer.Abiomed has used the manuscript submission date of (b)(6) 2017 as the date of the event.A (b)(6) year-old male with known coronary artery disease and stable angina was admitted to our facility with a prolonged chest pain episode at rest, associated with dyspnea.An impella cp was successfully placed.Following pci, the patient suffered acute profound hypotension necessitating intravenous fluids and vasopressor support with epinephrine.The impella device was removed and selective left common iliac angiogram from the right femoral access revealed a vascular injury site with an indication of a retroperitoneal hematoma.An 8.0 × 59 mm icast covered stent was deployed to the left external iliac artery with successful sealing of the perforation.The impella device site was closed with two perclose devices.Computed tomography (ct) of the abdomen revealed large retroperitoneal bleeding along the plane of left external iliac artery.The patient required 4 units of packed red blood cell transfusion.The patient was discharged from the hospital 10 days later.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED, INC; 22 cherry hill drive; danvers MA 01923
• MDR Report Key: 7402781
• Report Number: 1220648-2018-00034
• Device Sequence Number: 679423
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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 Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2018
• 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: 70 YR