MAUDE Adverse Event Report: ABIOMED INC. IMPELLA; IMPELLA 5.0 AIC PUMP SET

Model Number 005062

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

The investigation of this event was done with what data was possible to obtain from the case report and a photograph shared of the access site.The product and data logs were not returned for analysis.In the photo the 5.0 repositioning unit suture tab appears to be separated from the decontamination sleeve during use.This separation could have taken place from an inadvertent pull with excessive force.In addition the type of graft used could have contributed to the hematoma and blood loss.The graft was not the one abiomed recommends for axillary 5.0 support.Abiomed recommends a woven graft while the one used in this procedure was knitted.The ifu for the graft states: "clamping may damage any vascular prosthesis.Excessive force should be avoided, as it will damage the polyester fibers and the gelatin impregnation." no corrective actions are to be taken as the root cause could not be determined without product being returned for analysis.The failure mode is determined to be low risk, no corrective action is recommended and the failure mode will be monitored and trended.Internal reference:(b)(4).Device not returned.

Event Description

The patient was transferred to the hospital for escalation of care on (b)(6) 2016.The patient had a history of cardiomyopathy and cabg.The impella 5.0 was placed successfully via the axillary access cutdown.The graft that the physician used was not the normally placed one, but rather a knitted graft, the gelsoft plus 10x30.This was not the abiomed recommended hemoshield plus.The support with the 5.0 pump continued for four days as the patient was stabilized for a planned angioplasty.An intervention was done on the saphenous vein graft to the diagonal branch.Three days after the angioplasty the patient returned to the operating department for the explantation of the 5.0 pump.The patient's pump had been pulled back inadvertently during the patient support and the suture wing tab was separated from the sleeve of the pump.There had been noted a report of "excessive force" being applied and causing inadvertent separation of the blue butterfly tab.A hematoma had developed during the surgical day underneath the dressing and so blood products were given.The vascular surgery team removed the hematoma and applied vessel loops to control the bleeding.The patient had been supported by the 5.0 for 6 days successfully and there was no lasting harm or injury from the hematoma nor the broken blue butterfly tab.

• Brand Name: IMPELLA
• Type of Device: IMPELLA 5.0 AIC PUMP SET
• Manufacturer (Section D): ABIOMED INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer (Section G): ABIOMED EUROPE GMBH; neuenhofer weg 3; aachen 52074 ; GM 52074
• Manufacturer Contact: william bolt ; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 6159525
• MDR Text Key: 62126146
• Report Number: 1220648-2016-00046
• Device Sequence Number: 1
• Product Code: OZD
• UDI-Device Identifier: 00813502011180
• UDI-Public: 00813502011180
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DO79844
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2017
• Device Model Number: 005062
• Device Catalogue Number: IMPELLA 5.0
• Device Lot Number: 1216804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2016
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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: GELOSOFT PLUS 10X30 GRAFT BY (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR