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	Device Issue (2379)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The impella cp and data logs were returned for analysis.The pump evaluation revealed large biomaterial in the pump housing, as well as impeller damage consisting of a detached impeller blade.As stated in the event description the device was returned and the evaluation of the pump revealed large biomaterial in the pump housing and revealed impeller damage consisting of a detached impeller blade.Biomaterial ingestion is known to cause suction; however, the biomaterial needed to be removed to complete the device evaluation and the pump could not be run with it in place.Although the pump was not run with the biomaterial present during testing, it can be confidently stated that there is a chance this is what caused the suction issues reported in the case.The root cause of the breakage was unable to be definitively determined.The failure mode will be trended and monitored.(b)(4).
Event or Problem Description
The complainant reported that a (b)(6) man was supported with an impella cp for 46.49 hours.After approximately 24 hours of patient support suction alarms occurred.Patient support continued for another 22.49 hours.The device was removed from the patient.The patient was alert and oriented.There were no adverse patient effects as a result of the reported suction.The device was returned and the evaluation of the pump revealed large biomaterial in the pump housing and revealed impeller damage consisting of a detached impeller blade.Biomaterial ingestion is known to cause suction; however, the biomaterial needed to be removed to complete the device evaluation and the pump could not be run with it in place.Although the pump was not run with the biomaterial present during testing, it can be confidently stated that there is a chance this is what caused the suction issues reported in the case.

• 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: 7329022
• Report Number: 1220648-2018-00012
• Device Sequence Number: 18871902
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1310666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR