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

Model Number	IMPELLA CP
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Torn Material (3024)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella cp product was returned for analysis.The data logs are not applicable to the failure mode and were therefore not a part of the event analysis.Upon review of the returned product, there were two tears discovered along the tip of the wound closure.The lot of wound closure had no other complaints leveled against it.The root cause of the bleeding was the tear at the wound closure.There is a capa for this failure mode.The failure will be monitored and trended.(b)(4).
Event or Problem Description
A (b)(6) male transported himself to the hospital emergency room and promptly coded, went into ventricular tachycardia, and after successful resuscitation, was taken to the cardiac cath lab.An angioplasty was performed with an impella cp being utilized for hemodynamic support.After the angioplasty the patient was sent to the icu with the cp for continued support and monitoring.While in the icu the pump position was checked via echo and repositioned.After repositioning, the team noticed a groin access site hematoma was developing and began to hold pressure at the site.The patient's heart rate increased and blood pressure was decreasing at this time.When the bleeding was unable to be controlled, and with the patient condition deteriorating, the team chose to send the patient to the operating room (or) for evaluation of the groin site.While in the operating room (or), the cardiothoracic surgeon performed a cutdown to the site and the vessel was repaired.The team did not infuse any blood products and noted the patient to be stable after vessel repair and impella cp explant.Upon review of the cp post explant the team noted that the repositioning sheath of the cp had a tear of unknown etiology.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen, 52074 ; GM 52074
• MDR Report Key: 7227258
• Report Number: 1220648-2018-00001
• Device Sequence Number: 1022529
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P1400003
• 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): 01/03/2018

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: 08/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1304914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/30/2018
• 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: 56 YR