MAUDE Adverse Event Report: ABIOMED 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 Code	Ischemia (1942)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date there are no results available.No product has been returned, nor have requests for clinical patient information been satisfied.The data logs have recently arrived for analysis, but the investigation is on-going.When results have been found and/or additional information is discovered, a supplemental report will be filed.Internal reference 17-1219.
Event or Problem Description
A (b)(6) male with a history of multivessel coronary artery disease was admitted for revascularization via an angioplasty of the chronic totally occluded right coronary artery (rca).The patient had a successful procedure, but when being moved from the cardiac catheterization lab, the patient went into ventricular fibrillation and subsequently coded due to a thrombosed rca.The patient was again intervened upon and the rca was re-opened.Due to his instability, the impella cp was placed for hemodynamic support, a temporary pacemaker was placed, and a hypothermia protocol was initiated.Once the impella cp was placed, the patient was transferred to the icu for monitoring.During his two days in the icu, the impella pump position was confirmed and the patient treated with cardiac iv drips and evaluated by vascular surgery.Vascular was consulted due to a cool limb in the leg the impella was placed.The surgeon chose not to treat the leg, rather to allow the impella to remain within the left leg for hemodynamic support until the patient could be weaned from the impella hemodynamic support.The following day the patient's limb was improving but it was still decided to wean the patient from his impella cp support.The weaning process took place over 6 hours.After the weaning completed, the patient had his impella explanted.Shortly after explant, the patient began to decompensate and did expire.The cause of the patient's outcome is not known at this time.The patient was in need of further coronary revascularization in the form of coronary artery bypass surgery.

• 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: 7182095
• Report Number: 1220648-2017-00136
• Device Sequence Number: 1044263
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 12/14/2017

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: 09/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1310563
• 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: 12/14/2017
• Initial Report FDA Received Date: 01/11/2018
• 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: 55 YR