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

Model Number	IMPELLA CP
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Blood Loss (2597)
Date of Event	01/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for analysis.The data logs are not relevant to the failure mode, and were not gathered for analysis.There was damge noted on the 15fr portion of the pump, at the wound closure.The timing of when the damage occurred is unknown.The damage most likely contributed to the bleeding observed during the case support.The root cause of the bleeding is unable to be determined.The failure will be monitored and trended.(b)(4).
Event or Problem Description
A (b)(6) male was admitted with influenza.In his workup multivessel coronary artery disease was diagnosed.He was sent for bypass surgery with impella cp being utilized for hemodynamic support.After the bypass grafts were placed, and the patient was taken off-pump, the impella groin access site was seen to have pulsatile blood flow.Due to the blood loss, the impella was explanted, and the patient had a surgical intervention and repair of the torn common femoral artery.A new impella cp was placed for continued support at the left femoral artery, via a newly placed 6cm hemashield platinum graft, and his hemodynamic support continued until support was withdrawn at the request of the family.

• 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: 7282770
• Report Number: 1220648-2018-00005
• Device Sequence Number: 1133483
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2018

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: 07/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1299265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2018
• 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: 77 YR