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

Model Number 004334

Device Problems Difficult to Insert (1316); Suction Problem (2170); Device Displays Incorrect Message (2591); Positioning Problem (3009)

Patient Problems Hemolysis (1886); Hematuria (2558)

Event Date 01/28/2016

Event Type  Injury  

Manufacturer Narrative

The impella cp is still under evaluation.Additional information of the details of this event are currently being sought.It is unclear if this reported issue was related to the impella rp, or if this issue was the result of the physician's device placement/management, or the patient's condition.The manufacturer will continue to investigate all reasonable obtainable source information and will provided the evaluation results and updated conclusions in a supplemental report.(b)(4).Device currrently undergoing evaluation.

Event Description

The complainant reported that the physician was treating a (b)(6) male patient who had been transferred to the facility.On (b)(6) 2016 an impella cp ((b)(4)) was initially placed in the patient for bivad support.On (b)(6) 2016 the impella rp was also implanted.It was then decided to also replace the impella cp with an impella 5.0 ((b)(4)) to escalate the level of support to the patient.The impella cp was removed from the patient on (b)(6) 2016 after 27.35 hours of patient support, and the impella 5.0 was placed.The impella rp had been placed on (b)(6) without issue.The following day suction alarms occurred, and the performance level was reduced and the suction alarms resolved.On (b)(6) the impella rp pump was removed from the patient as a result of continued suction alarms and in an effort to obtain better pump positioning.A new sheath was obtained and the same impella rp was again placed in the patient.During this second placement of the device difficulties were incurred in getting the pump in.The proper location.The pump was successfully placed.Following this second placement of the device the patient exhibited severe hemolysis requireing 3 to 5 units of replacement blood products to be administered to the patient.This impella rp was removed from the patient and a new impella rp was placed.This pump functioned without issue and the patient hemolysis was resolved.Due to the patient's medical conditions the patient's family withdrew medical support on (b)(6) 2016 and the patient expired.The physician reported that the patient outcome was unrelated to the patient's hemolysis.

Manufacturer Narrative

The impella rp was returned for evaluation.In addition, the console logs were also returned for analysis.The evaluation of the pump revealed a significant amount of thrombus around the leading edge of the impeller, as well as the seal around the purge gap.After attaching a new catheter and plug to the pump and connecting it to a console the impella rp pump passed functional testing.The pump lost position multiple times due to patient hiccupping and the impella rp pump had to be repositioned under x-ray.Hemolysis testing was also conducted to determine if the patient's hemolysis was due to defects of the impella rp pump.The pump was attached to another impella rp pump plug and the hemolysis bench test was performed.The results of the test revealed that the pump had an mih value of 6.2 at p9, which is a low normal value.This result indicates that this impella rp pump did not contribute to hemolysis in the patient.There were two issues for this case including: hemolysis, elevated ps.Patient records show that his pfhg was at elevated levels prior to implantation of pump.The analysis of the console logs reveal that the increase pfhg levels during patient support align with suction alarms and improper pump positioning.After the pump was replaced the patient's hemolysis level was reduced.The hemolysis testing on the pump revealed that there was no abnormal pump related hemolysis.Based on the symptoms, there is high probability that biomaterial was suctioned in ph, resulting in impeller rotational interference.Post explant inspection discovered ingested clots.The following has been determined to be the root cause of this event: patient records show that pfhg was at elevated levels prior to implantation of pump.Based on the symptoms, there is a high probability that biomaterial was ingested.Post explant inspection discovered clots.Performance in a standard hemolysis test in the lab showed pfhg level at 6.2 proving that the impella rp pump was not the cause of hemolysis.As a conclusion, the hemolysis was caused by possible pump position during the suction periods with elevated pfhg.It is not clear that there is a link between improper positioning and biomaterial ingestion.The hemolysis was not pump related.(b)(4).

• Brand Name: IMPELLA RP
• Type of Device: IMPELLA RP
• Manufacturer (Section D): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen, germany 13059 , GM; GM 13059, GM
• Manufacturer (Section G): ABIOMED EUROPE, GMBH (GERMANY); neuehofer weg 3; aachen, germany MA 13059 , GM; GM 13059, GM
• Manufacturer Contact: william bolt ; abiomed, inc.; 22 cherry hill drive; danvers, MA 01923 ; 9786461451
• MDR Report Key: 5464208
• MDR Text Key: 39196713
• Report Number: 1220648-2016-00003
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: 004334
• Device Catalogue Number: 004343
• Device Lot Number: 1206932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/28/2016
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2016
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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): Required Intervention
• Patient Age: 44 YR