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	Hematoma (1884); Blood Loss (2597)
Date of Event	11/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella cp and other disposables were discarded following removal from the patient; consequently an evaluation of the pump at issue could not be performed.A console data log analysis was not included in this report because data logs are not relevant to this failure mode.Without the device or repositioning sheath returned for investigation the cause of the femoral artery damage could not be determined.A manufacturing review was performed for the impella cp used during this event, which revealed that there were no material review reports or reworks that apply to this failure mode.In addition, a review of the device history record was performed and it did not reveal any complaints against this lot of impella cp pumps.The repositioning unit was from lot number 1282116, and its tapered wound closure was from lot number 1701271.All units selected from this lot passed incoming inspection.There were no complaints for failures of other repositioning units from this lot.The root cause of the hematoma was unable to be determined as the product was not returned from the field.No corrective action is recommended as the failure mode was determined to have a low risk index based on moderate severity and very low occurrence and the root cause was not determined.Failures of this type will continue to be monitored for trends.Failures of this type will continue to be monitored for trends.Internal reference: (b)(4).
Event or Problem Description
The complainant reported that a (b)(6) male patient was being treated at the facility as a result of having experienced 2 successive days of internal cardiac defibrillator (icd) shocks of increasing frequency due to a ventricular tachycardia heart rhythm.The patient was reported to have a history of multiple comorbidities including a coronary bypass graft performed 22 years ago, hypertension, hypersensitivity lung disease, chronic kidney disease, diabetes mellitus, chronic myofascial pain, cardiomyopathy, and an implanted biventricular pacemaker and cardioverter-defibrillator.Upon admission to the hospital the patient had an ejection fraction of 15%, and his act was over 300.On (b)(6) 2017 a ventricular tachycardia ablation was performed in the ep lab.After the physician burned a couple of sites during the procedure the patient went into a pulseless electrical activity (pta) and arrested.Cpr was then initiated.The impella cp was then placed in the patient via the left femoral artery (lfa) without difficulty.During the impella support the patient would drift into period of no ejection, then no contractility whatsoever, requiring further compressions.The decision was then made to escalate to a v-a ecmo the impella peel-away sheath was removed and the repositioning sheath was advanced.During this time a small hematoma developed immediately.Manual pressure was held, and the site was then soft and looked good.When the ecmo was placed, and after 10,000 units of a heparin bolus was administered, the hematoma rapidly expanded with continued bleeding around the repositioning sheath.Manual pressure continued to be held, and vascular surgery was called.The ecmo was completed and the impella purge pressure was reduced for left ventricle decompression, exploration by the vascular surgeon revealed bleeding all around the repositioning sheath.The impella cp was then removed from the patient after 4.85 hours of hemodynamic support.The vessel was repaired and a chimney graft was placed.Another impella cp was placed for left ventricle venting.Patient blood loss was estimated to be 2,000 cc's, although the patient's act was over 300/second.The patient was administered 6 units of replacement packed red blood cells (prbc.) the patient was eventually transferred to another facility for further treatment.There was no indication from the complainant of any additional adverse effects to the patient as a result of the reported issue.

• 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: 7140206
• Report Number: 1220648-2017-00117
• Device Sequence Number: 1328050
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• 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): 11/23/2017

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: 06/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1294891
• 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: 11/23/2017
• Initial Report FDA Received Date: 12/21/2017
• 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: 61 YR