MAUDE Adverse Event Report: ABIOMED EUROPE, GMBH (GERMANY) IMPELLA RP

Model Number 004334

Device Problem Device Handling Problem (3265)

Patient Problem Blood Loss (2597)

Event Date 06/27/2015

Event Type  Death  

Event Description

The complainant reported that the clinicians were treating a (b)(6) male patient who was nitric oxide dependent, and was 2 weeks post left ventricular assist device placement.The patient was prepped for impella rp placement in order to provide primary support.A swann was placed in the left pulmonary artery with a 0.035 wire.An oscor rp sheath was placed.The patient's act reading was 202, and he was given and additional heparin bolus of 5000 units prior to the removal of the dilator.The swan-ganz catheter was placed deep in the lpa followed by the 0.025 wire.At this point the patient began bleeding quite a bit from the sheath's valve before the impella rp was placed.Attempts to reset the valve were unsuccessful.The impella rp catheter was primed and back-loaded, and was placed into the oscor rp sheath, and then advanced to the inferior vena cava and zeroed.During the advancement, the catheter passed the tricuspid to the pulmonic valve, but then the wire prolapsed and was pulled from the left pulmonary artery.The physician was able to advance the wire while still on the impella rp into the right pulmonary artery.The patient bleeding had continued throughout the impella rp insertion.At this time the physician ordered a transfusion of blood, and 4 units were administered to the patient.Due to patient bleeding the staff decided to accept a right pulmonary artery position for the device.The impella rp placement was completed, the introducer was removed and the physician performed a deep mattress suture for hemostasis, no additional bleeding issues occurred from the oscor sheath.The patient was supported by the impella rp for over 16 days, and the patient continued decompensating due to his underlying condition of pulmonary hypertension, sepsis and being vasodilated.The impella rp was removed from the patient on (b)(6) 2015 as the patient's family withdrew care.On (b)(6) 2015 the patient expired.The patient outcome was not as result of any issue with the impella rp.

Manufacturer Narrative

The device was returned for evaluation for the introducer failure.The clinical information and introducer were analyzed for the failure investigation.The clinical information described the patient bleeding from the introducer valve after insertion of the swan ganz catheter into the left pulmonary artery.This bleeding was not resolved before or during insertion of the impella rp into the patient.The examination of the valve on the sheath revealed an off-centered tear, likely occurring during insertion of the swan ganz.This off-centered insertion resulted in a torn and open valve condition that continued during the remainder of the case, including during the insertion fo the impella rp.The root cause of this reported event has been determined to be the off-centered insertion of the swan-ganz catheter through the oscor sheath which led to the bleeding from the introducer.Additional staff inserviceing has been performed.

• Brand Name: IMPELLA RP
• Type of Device: IMPELLA RP
• Manufacturer (Section D): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen,, germany 13059, gm 13059 , GM; GM 13059, GM
• Manufacturer (Section G): ABIOMED, INC.; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: william bolt ; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 4943485
• MDR Text Key: 6252712
• Report Number: 1220648-2015-00006
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H140001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2015

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: 004334
• Device Catalogue Number: 004334
• Device Lot Number: 1193394
• Other Device ID Number: 565404779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2015
• Initial Date Manufacturer Received: 06/27/2015
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2017
• 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): Death; Required Intervention
• Patient Age: 54 YR