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	Positioning Problem (3009)
Health Effect - Clinical Codes	Hemolysis (1886); Patient Problem/Medical Problem (2688)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has not been released by the user facility.If the product is received by the manufacturer for evaluation, a follow up report will be submitted.(b)(4).
Event or Problem Description
A (b)(6) year old female patient presented with a history of prior cabg and mitral valve replacement, acute myocardial infarction and cardiogenic shock on (b)(6).An impella cp was implanted successfully on (b)(6) following removal of an iabp.The patient was experiencing leg ischemia on (b)(6).The clinical staff noted the patient's posterior tibial pulses had been dopler audible at baseline, however on the 21st tibial pulses became dopler absent distal to the impella site.Ultrasound revealed an occlusive thrombus, however the decision was made not to do intervention at that time due to the grave prognosis.The patient was reportedly very unstable and was shocked several times on the (b)(6), and the family elected to withdraw care.

• 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: 7205840
• Report Number: 1220648-2017-00130
• Device Sequence Number: 853963
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/26/2017

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: 04/30/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1239018
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2018
• 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; Disability
• Patient Age: 75 YR