IMPELLA RP 004334

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-07-20 for IMPELLA RP 004334 manufactured by Abiomed Europe Gmbh.

Event Text Entries

[114602947] The device was returned to abiomed for evaluation. The catheter was found to have been cut, which was done by the clinicians to maintain access for va ecmo insertion after the impella rp was explanted. This disallowed the ability to perform hemolysis testing of the returned impella rp. A thrombus was noted to be inside the pump housing on the impeller, but no other defects were found on the pump. The automatic impella controller's data logs were returned for this case. The analysis of the logs revealed that the pump had been run for a total of about 12 hours. There were no alarms that triggered related to the failure mode throughout patient support. There was elevated and changing placement signals throughout, which could correlate with the biomaterial ingestion. The changes in the placement signal and motor current during support indicated either changing position or interaction with patient vasculature or ingested biomaterial during this time. A review of the device history record revealed that there had been no issues found during the manufacture or inspection of the device that apply to this failure mode. In addition, there have been on complaints reported related to this failure mode. The root cause of the hemolysis was most likely thrombus ingestion, but this could not be definitively determined as hemolysis testing could not be completed on the pump. No corrective action is recommended at this time as the root cause of the hemolysis was unable to be definitively determined. Failures of this type will continue to be monitored for trends.
Patient Sequence No: 1, Text Type: N, H10


[114602948] On (b)(6) 2018 a (b)(6) year old male patient with post-cardiotomy cardiogenic shock had post aortic valve replacement surgery. The valve replacement surgery was difficult, and a va ecmo device was placed urgently. The ecmo was decannulated after supporting the patient for 24 hours, the patient was administered 2 units of packed red blood cells and an impella rp was placed in the patient. The physician did not use echo to evaluate for clotting prior to the rp insertion. It was reported that there was heparin in the purge solution from implant, but not systemically administered due to bleeding from the ecmo insertion site. During the night patient hemolysis occurred. The labs continued to indicate hemolysis, and the patient's urine output was black. Under x-ray the pump appeared to be located just below the pulmonic valve. The staff was unable to get the heparin level up due to the hemolysis. The impella rp was unable to be repositioned, and on (b)(6) 2018 the impella rp was removed and a va ecmo was placed in the patient. Patient care was withdrawn on (b)(6) 2018 and subsequently expired on that same date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220648-2018-00073
MDR Report Key7707061
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-07-20
Date of Report2018-06-22
Date of Event2018-06-22
Date Mfgr Received2018-06-22
Device Manufacturer Date2017-09-22
Date Added to Maude2018-07-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RALPH BARISANO
Manufacturer Street22 CHERRY HILL DRIVE
Manufacturer CityDANVERS 01923
Manufacturer CountryUS
Manufacturer Postal01923
Manufacturer Phone9788828068
Manufacturer G1ABIOMED EUROPE GMBH
Manufacturer StreetNEUENHOFER WEG 3
Manufacturer CityAACHEN 52074, GM,
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA RP
Generic NameTEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP
Product CodePYX
Date Received2018-07-20
Returned To Mfg2018-06-28
Model NumberIMPELLA RP
Catalog Number004334
Lot Number1301336
Device Expiration Date2019-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerABIOMED EUROPE GMBH
Manufacturer AddressNEUENHOFER WEG 3 AACHEN 52074, GM, GM


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Required No Informationntervention 2018-07-20

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