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 Code	Ischemia (1942)
Date of Event	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to the manufacturer for evaluation.The evaluation of the impella rp revealed a split in the outer sheath of the repositioning unit/sheath, as well as biomaterial around the impeller of the pump.In conclusion, the peel away sheath was left inside of the patient's femoral artery during surgery.The patient had severe pvd and an amputation on the other leg.Following the surgery there was a delay in restoring pump flow due to complications requiring additional surgical intervention.The ischemic leg may have been the result of leaving the peel-away sheath inside of the patient's artery during surgery, despite the patient being high risk for limb ischemia, along with the extended loss of hemodynamic support following the bypass operation; however, this cannot be definitively concluded.(b)(4).
Event or Problem Description
The complainant reported that a (b)(6) year old female patient with peripheral artery disease (multi-vessel vessel coronary artery disease with high grade stenosis) had an impella cp placed via the right leg's femoral artery.This patient had previously undergone a lower left extremity amputation.The impella cp was placed to rest the heart.The peel-away sheath was left in place to allow the cardiovasular surgeon to eventually remove the device without having to manage the access site.Following bypass surgery, the patient developed a cold leg, resulting in vascular surgery, during which the leg was amputated.The patient expired 3 days later on (b)(6) 2018.The physician reported that the patient outcome was unrelated to any issue with the impella rp, as the patient would not have made it to the or without the support of the pump.

• 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: 7487724
• Report Number: 1220648-2018-00030
• Device Sequence Number: 13944050
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (Y/N): N
• 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): 02/21/2018

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: 12/22/2017
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1316051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: 51 YR