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

Model Number	IMPELLA CP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was nor returned for evaluation as it was discarded by the user following patient support.There are no definitive information indicating that the use of the impella was the cause of the femoral dissection.The clinicians reported that they believed that per-close challenges indicated potential arterial calcification and mild peripheral vascular disease.The root cause of vascular damage could not be determined because the pump was not returned to abiomed for investigation.(b)(4).
Event or Problem Description
The complainant reported that the patient was taken to the coronary catheterization lab for removal with bilateral access, catheter cross-over and balloon tapenade for 20 minutes.In addition 10 to 15 minutes of manual compression was performed.Following removal of the impella cp it was found that the patient's femoral artery was dissected.The patient was taken to surgery where the arterial repair was successfully performed.The patient's 19 hours of impella cp support was reported as successful and the patient was reported to be in stable condition.

• Brand Name: IMPELLA CP
• Common Device Name: TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, PRODUCT
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074, gm, ; GM
• MDR Report Key: 7304742
• Report Number: 1220648-2018-00013
• Device Sequence Number: 1847177
• 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: P140003
• 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): 01/30/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1312624
• 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: 01/30/2018
• Initial Report FDA Received Date: 02/28/2018
• 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: 47 YR