MAUDE Adverse Event Report: ABIOMED EUROPE GMBH IMPELLA 5.0; PUMP,BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number IMPELLA 5.0

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance (2578); Device-Device Incompatibility (2919)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

The root cause of the cannula detachment could not be determined as not all product was returned.The portion of the pump explanted through the cook sheath was returned, but not the sheath itself, nor the pump portion that remained within the sheath.The pump ring and inlet cage of the pump were not able to be analyzed.The cannula was analyzed and found to be stretched when compared to a sample 5.0 pump.The outflow cage was twisted and the bond between the pump housing and motor housing was damaged.No data logs were returned for analysis.A manufacturing review found no other complaints against this lot of impella 5.0 pumps.The failure will continue to be monitored and trended.(b)(4).

Event Description

A (b)(6) male was admitted to an outlying facility and received an iabp for hemodynamic support.The patient was transferred to the tertiary facility with an ef of 25% and the decision was made to place an impella 5.0 via the transcaval approach on (b)(6).The transcaval access was performed via the cook 24fr x 65 cm sheath.The iabp was then explanted.The patient began to experience signs and symptoms of hemolysis in the form of hemolyzed labs on the following day of support, the (b)(6).The pump position was assessed by echo and not repositioned.The patient was monitored and the renal function was observed during his ongoing dialysis.The team began to question if the hemolysis was due to rhabdomyolysis on (b)(6) , rather than solely the use of the impella 5.0.As the patient's deterioration continued, the family chose to withdraw care.Upon removal of the transcaval sheath and explant of the 5.0 pump, the pump met resistance coming out of the sheath.They continued to pull on the device and the pump came out of the sheath but, the cannula had become detached from the inlet cage.The inlet cage and pigtail remained inside the sheath while the rest of the pump was explanted.As the care was withdrawn, the team did not snare or remove the remaining portion or exchange the sheath.The patient was allowed to expire with product retained.

Manufacturer Narrative

On december 12, 2017 a user initiated medwatch was received, (b)(4).No new clinical details were provided since manufacturer filed medwatch 1220648-2017-00089.Internal reference (b)(4).

• Brand Name: IMPELLA 5.0
• 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; 22 cherry hill drive; danvers MA 01923
• Manufacturer Contact: ralph barisano ; 22 cherry hill drive; danvers, MA 01923 ; 9786461400
• MDR Report Key: 6990219
• MDR Text Key: 91916487
• Report Number: 1220648-2017-00089
• 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: K0831111
• 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: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2019
• Device Model Number: IMPELLA 5.0
• Device Catalogue Number: 005062
• Device Lot Number: 1287177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• 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: 76 YR