MAUDE Adverse Event Report: ABIOMED EUROPE GMBH IMPELLA RP; PUMP, BLOOD,CARDIOPULMONARY BYPASS NON-ROLLER TYPE

Model Number IMPELLA RP

Device Problems Device Issue (2379); Patient-Device Incompatibility (2682)

Patient Problem Hemolysis (1886)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

To date the impella rp pump product and data logs have not been returned for investigative analysis.The return process from the field has begun.Pending return of the product and data logs, the only review possible has been that of the manufacturing records.There are no other complaints made against this lot of impella rp pumps for the failure mode of hemolysis.The root cause of the hemolysis can not be determined at this time.The manufacturer will continue to investigate all reasonable obtainable source information, and will file a supplemental medwatch report if they become available.(b)(4).

Event Description

On the (b)(6), a (b)(6) year old male was admitted with back and shoulder pain.The patient was taken to the cardiac catheterization lab and a ventricular septal defect (vsd) was observed.The vsd was thought to be caused by a myocardial infarction.An impella cp was placed for support.Four days later, on the (b)(6), due to right ventricular failure, and impella rp was placed for right heart support.The patient returned to the icu and was monitored for right heart filling and given fluids.The patient's condition decompensated on the night of the (b)(6) and the team drew labs to confirm a diagnosis of hemolysis.After twenty two hours of impella rp support the pump, the rp was explanted and va- extracorporeal membrane oxygenation (ecmo) was placed due to concerns of hemolysis.On the (b)(6), the team cared for the hemolysis and proceeded with support.The patient's support continued with the va- ecmo and impella cp for ten more days.During these days of support, the patient experienced multiorgan failure, was placed on dialysis, received blood product replacement, and eventually care was withdrawn.The patient expired on the (b)(6) 2017.

Manufacturer Narrative

After the initial medwatch report was filed and submitted on september 11, 2017 the product and data logs were returned for analysis.The impella rp pump was inspected and run through abiomed in-house hemolysis testing.The pump passed hemolysis testing.The root cause of the hemolysis could not be determined.The data logs were analyzed and the logs show that the pump performed without issue.No corrective action is recommended as the failure mode was unable to be determined.The failure mode will be trended and monitored.Internal reference (b)(4).

• Brand Name: IMPELLA RP
• Type of Device: PUMP, BLOOD,CARDIOPULMONARY BYPASS NON-ROLLER TYPE
• Manufacturer (Section D): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen, 52074 ; GM 52074
• 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: 6856311
• MDR Text Key: 85740856
• Report Number: 1220648-2017-00071
• Device Sequence Number: 1
• Product Code: OJE
• UDI-Device Identifier: 00813502010022
• UDI-Public: 00813502010022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H14001
• 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,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: IMPELLA RP
• Device Catalogue Number: 0046-0019
• Device Lot Number: 1289242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR