MAUDE Adverse Event Report: ABIOMED INC. IMPELLA; TEMPORARY CARDIAC SUPPORT BLOOD PUMP

Model Number IMPELLA CP

Device Problems Kinked (1339); Device-Device Incompatibility (2919); Human-Device Interface Problem (2949); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

The cp pump was returned for investigation.The cannula of the pump was torn and still within the a portion of the cook sheath.The sheath was cut in two placed and had kinks throughout its length.There were numerous kinks observed.The kinks distal to where the sheath was cut by the physician were likely caused during the clamping and subsequent snaring of the sheath by the vascular surgeon.The damage to the cannula was caused when the physician applied excessive force to the pump when it became caught within the sheath during explantation.The pump was unable to pass through the sheath due to the observed kinks in the sheath.These kinks were most likely caused by the vascular tortuousity.This known tortuosity had prompted the team to utilize the cook sheath.The data logs did not pertain to the investigation, and therefore were not analyzed.The root cause of the damge to the cannula was the excessive force applied.Failures of this type will be monitored and trended.(b)(4).

Event Description

A (b)(6) male was admitted with multivessel coronary artery disease, diabetes, hypertension, and mild mitral valve disease.The plan was to place an impella cp for support during multivessel revascularization in the cardiac catheterization lab.While in the cath lab, a swan was placed to monitor right heart pressures, and the cp was placed via a cook 14fr x 30cm (abiomed approved) sheath in the left femoral artery.The left femoral was known to have tortuosity, and the cook sheath would provide adequate support.To assist with the groin access site closure the team placed 2 perclose in the "pre-closing" method to the left femoral artery.During the catheterization procedure, the patient's pressures were labile and there was intermittent hypertension.Therefore, the cp pump weaning process was begun in anticipation of explant.During pump explant, the cp was unable to be eased out of the cook sheath's valve.The physician then applied force to pull the pump back.During this pull through the sheath, the cannula of the pump was damaged with the internal nitinol coil observed outside of the sheath and the remaining portion of the pump caught within the sheath.The team then used fluoroscopy to confirm the remaining portion of the pump was intact and within the cook sheath.The sheath was clamped and cut so that the remaining portion of the pump could be removed.As the physician tried to maintain vascular access, the remaining portion of the cook sheath migrated into the femoral artery.A vascular surgeon was able to emergently remove the remaining portion of the cook sheath.The sheath was snared out and removed via the contralateral leg.The team then completed the perclose procedure of the left femoral and the patient was sent to the icu for a successful recovery.

• Brand Name: IMPELLA
• Type of Device: TEMPORARY CARDIAC SUPPORT BLOOD PUMP
• Manufacturer (Section D): ABIOMED INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 6841943
• MDR Text Key: 84755764
• Report Number: 1220648-2017-00064
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011258
• UDI-Public: 00813502011258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P1400003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: IMPELLA CP
• Device Catalogue Number: 0048-0003
• Device Lot Number: 1273798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK SHEATH 14FR X 30CM; PERCLOSE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR