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

Model Number	IMPELLA CP
Medical Device Problem Codes	Kinked (1339); Difficult to Remove (1528); Device Issue (2379)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Blood Loss (2597)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The impella pump was returned for analysis.The data logs were not retrieved.Upon examination of the pump there was damage noted as the catheter was stretched and broken.Biomaterial was observed within the catheter's cannula.The pump housing was noted to be deformed and damaged.The root cause of the femoral artery dissection was most likely the excessive force used to remove the guidewire and pump.The root cause of the necessity for this excessive force is unable to be determined.No corrective action is warranted, the failure mode will be monitored and trended.Internal reference (b)(4).
Event or Problem Description
A patient admitted with cardiogenic shock and acute mi had an impella cp placed with difficulty via the right femoral artery during cpr.Due to the pump kinking, when the guidewire was removed, the pump was explanted to resolve the kink.Upon reinsertion the right femoral artery was observed to be dissected.The patient had the dissection tamponade by the placement of a 14fr introducer and the case and cpr continued, until his death from cardiogenic shock and failed cpr and defibrillations.

• 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: 7496264
• Report Number: 1220648-2018-00041
• Device Sequence Number: 13788027
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P140003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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: 10/31/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1319167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: 52 YR